Viewing Study NCT06230627



Ignite Creation Date: 2024-05-06 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:19 PM
Study NCT ID: NCT06230627
Status: COMPLETED
Last Update Posted: 2024-01-31
First Post: 2024-01-19

Brief Title: Feasibility of Home-Based Rehabilitation on Body Composition Some Anthropometric Measures and Muscular Strength After Interruption 4-5 Years of Spinal Cord Injury Serial Cases Study on ISIS War Survivors in Iraq
Sponsor: University of Mosul
Organization: University of Mosul

Study Overview

Official Title: University of Mosul College of Physical Education and Sport Sciences University of Sfax High Institute of Sport and Physical Education at Sfax
Status: COMPLETED
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HBRP-SCI
Brief Summary: Feasibility of Home-Based Rehabilitation on Body Composition some Anthropometric Measures and Muscular Strength after interruption 4-5 years of Spinal Cord Injury Serial Cases Study on ISIS War Survivors in Iraq

Summary Background The war in Mosul wrecked hospitals and rehab centers leaving a gap in rehabilitation services This resulted in a need for alternative solutions for rehabilitation Objectives This study aims to create a home-based rehabilitation program HBRP that fits the participants39 surroundings and also detect and evaluate how effective it is in improving body composition some anthropometric measurements and muscle strength after a 4-5 year break in rehabilitation

Methods This voluntary controlled trial included 18 volunteers split into three groups 13 people with Spinal Cord Injury SCI their injuries time since 534-55 months They joined voluntarily into Two groups Eight in the experimental group Exp and Five in the first control 1st Con while Five were healthy individuals in the second control 2nd Con all around 212 years old on average The HBRP focused on muscles and whole-body joints by using the basic equipment and exercises right at the patient39s homes The program consisted of five weekly sessions with a gradually increasing achievement time of 45-120 minutes per session participants were given rest time between exercises based on their level and severity of injury The assessment was every three months

Results The study found that HBRP were not significant differences in weight BMI some anthropometric measures and some muscle strength tests However the HBRP had significant effects on waistabdomen pelvis and left thigh anthropometric variables with a large effect sizes and ranged between η2 084 - 095 and improvement percentages ranging from IP 24-162 also had a large effect size on all lower extremity tests head and trunk also improvement percentages were ranging 296-2428 exclude the pelvis elevating test Also there was a significant difference between the Exp and 1st Con group in the Eight muscles test P lt005 for the favour Exp group

Innovatively this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained 4 - 5 years ago This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances

Conclusions The study concluded that HBRP affected positively the muscles morphologically and functionally despite a stop in rehabilitation for a long period of 4-5 years for individuals with SCI
Detailed Description: Feasibility of Home-Based Rehabilitation on Body Composition some Anthropometric Measures and Muscular Strength after interruption 4-5 years of Spinal Cord Injury Serial Cases Study on ISIS War Survivors in Iraq

Summary Background The war in Mosul wrecked hospitals and rehab centers leaving a gap in rehabilitation services This resulted in a need for alternative solutions for rehabilitation Objectives This study aims to create a home-based rehabilitation program HBRP that fits the participant surroundings and also detect and evaluate how effective it is in improving body composition some anthropometric measurements and muscle strength after a 4-5 year break in rehabilitation

Methods This voluntary controlled trial included 18 volunteers split into three groups 13 people with Spinal Cord Injury SCI their injuries time since 534-55 months They joined voluntarily into Two groups Eight in the experimental group Exp and Five in the first control 1st Con while Five were healthy individuals in the second control 2nd Con all around 212 years old on average The HBRP focused on muscles and whole-body joints by using the basic equipment and exercises right at the patient39s homes The program consisted of five weekly sessions with a gradually increasing achievement time of 45-120 minutes per session participants were given rest time between exercises based on their level and severity of injury The assessment was every three months

Results The study found that HBRP were not significant differences in weight BMI some anthropometric measures and some muscle strength tests However the HBRP had significant effects on waistabdomen pelvis and left thigh anthropometric variables with a large effect sizes and ranged between η2 084 - 095 and improvement percentages ranging from IP 24-162 also had a large effect size on all lower extremity tests head and trunk also improvement percentages were ranging 296-2428 exclude the pelvis elevating test Also there was a significant difference between the Exp and 1st Con group in the Eight muscles test P005 for the favor Exp group

Innovatively this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained 4 - 5 years ago This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances

Conclusions The study concluded that HBRP affected positively the muscles morphologically and functionally despite a stop in rehabilitation for a long period of 4-5 years for individuals with SCI

Detailed Description

Feasibility of Home-Based Rehabilitation on Body Composition some Anthropometric Measures and Muscular Strength after interruption 4-5 years of Spinal Cord Injury Serial Cases Study on ISIS War Survivors in Iraq

Background

Spinal Cord Injury SCI is a complex pathology that requires skills in assessment treatment and rehabilitation SCI is a large topic area Approximately 90 of SCI cases occur as a result of traumatic causes Globally incidence varies from 40 to 80 cases per million population So people with injuries consequences are becoming more frequent due to conflicts and wars In Iraq the main reasons for the occurrence of this injury due to were the Islamic State in Iraq and Syria ISIS war which is resulting in enormous unmet rehabilitation needs Alarcon Cieza found in his study Rehabilitation the health strategy of the 21st Century that the rehabilitation stakeholders need to bring together the distinct portraits of rehabilitation under the concept of functioning because much of these unmet needs are concentrated amongst the poorest populations in low- and middle-income countries and conflict-affected settings which are often ill-equipped to cope with these increasing needs for rehabilitation services Iraq is regarded as one of these countries its health sectors including rehabilitation have been exhausted due to wars and armed violence However rehabilitation can be effective across almost all conditions therefore in some ways we should have been so backwards about recognizing the effectiveness of rehabilitation for many years

It is worth noting that healthcare problems are among the most complex problems faced by human beings especially under conditions of war armed conflicts terrorist operations and post-war secretions In low-middle income countries so many people would die from SCI within a year two years or three years from infection renal failure and so on and also people could not work and they either were at home or in residential care just waiting to die One of the defining characteristics of rehabilitation is that there are many interventions in contrast to most medical conditions rehabilitation can take place in any setting as a process for problem-solving

In Iraq war-related destruction of health institutions and rehabilitation centers has led to a focus on home-based rehabilitation programs HBRP and new sporting activities as positive and alternative approaches for rehabilitating individuals with SCI This article emphasizes the significance of home-based rehabilitation for individuals with SCI to prevent complications that arise from neglecting rehabilitation Neglecting rehabilitation can result in complex health problems a major concern observed among the study participants who discontinued rehabilitation due to ineffective and insufficient programs Additionally there was a notable mismatch between the participantscircumstances and the available rehabilitation systems and methods To ensure continuous and successful rehabilitation for individuals with SCI it is important to implement exercise regimes that intrinsically motivate them Robert et al confirmed that rehabilitation can occur at home and it is a practical matter of what is the best way to organize it so that the patient is safe the necessary equipment is available and the therapists and other team members time is used appropriately The process is a standard problem-solving process individualized to the patient which is necessary when solving any problem Reconsidering rehabilitation at home by introducing new sporting activities has been recognized as a positive and desirable area of rehabilitation 8

Objectives Innovatively this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained between 4 - 5 years ago This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances

The main contributions of this study are

To the best of the authors knowledge this is the first study in Iraq that highlighted the surviving victims of ISIS with SCIs

The preparation of a home-based rehabilitation program HBRP that lasted for six months and that was compatible with the participants living and environmental conditions as an alternative solution for conditions after the war also at the time of the COVID-19 pandemic when everything was under the closure

Assessing the effectiveness of rehabilitation on some anthropometric and physical variables in participants with SCI following participants stopping of rehabilitation for 4-5 years after SCI

The study raises two questions Does the home-based rehabilitation program HBRP affect people with spinal cord injury through interruption of rehabilitation for 4-5 years Is the HBRP effects on variables such as body composition Weight BMI Anthropometric Measures and Muscle strength Methods This voluntary controlled trial included 18 volunteers split into three groups 13 people with Spinal Cord Injury SCI their injuries time since 534-55 months They joined voluntarily into Two groups eight in the experimental group Exp and Five in the first control 1st Con while five were healthy individuals in the second control 2nd Con all around 212 years old on average As a first procedure detailed interviews were conducted with each participant at the beginning of the study to gather information about their physical psychological and social well-being This information helped the authors create personalized rehabilitation plans for each participant to ensure their participation in the study for the entire 6 months period Through our study objectives the authors used body composition such as height weight BMI and some anthropometric measurements for body parts circumferences by using tape measurements similar to a previous study by Akita et al Also muscle strength tests were performed on participants39 lower and upper extremities head and trunk to measure various movements The 2nd control group completed their measurements and tests at college Additionally a clinical test using the American Spinal Injury Association scale ASIA was conducted on each participant to assess sensory feeling and voluntary movement potential on both sides of the body

The physical tests were conducted using a handheld muscle tester called MicroFET2 to evaluate the strength of participants39 lower extremities head and trunk by using unit measure kilogram kg 11 The Exp group underwent a 6-month intensive rehabilitation program that involved whole-body exercises including stretching strength endurance and aerobic training which was prepared based on previous studies 12 The program included five weekly sessions of 45-120 minutes gradually increasing in intensity It encompassed various exercises like bed exercises rubber ball exercises for strength and balance trunk flexibility exercises crawling rolling ball-related movements and exercises on parallel bars Also aerobic exercises targeted cardiorespiratory fitness While weight exercises focused on the upper limbs shoulders chest and back Rest periods were personalized based on injury severity and overall health The authors updated the exercises based on regular assessments every 3 months tracking muscle strength and endurance The authors created a contact link for coordination among medical rehabilitative teams and participants families overcoming some challenges within the Iraqi healthcare system

To address complex complications like bed sores renal infections and muscle atrophy the authors followed the method of psychological support This method aimed to stimulate patients willpower encouraging them to overcome complications and emphasizing the benefits of rehabilitation for improved overall health and independence by made WhatsApp group was created to facilitate information sharing and provide visual evidence of successful cases inspiring and encouraging participants Furthermore the participant weight and BMI were monitored due to the potential impact of factors such as limited movement and hormonal changes on weight fluctuations as recommended in previous studies

The study highlights the participants the participants fidelity to treatment as evidenced by positive outcomes and sustained progress beyond the conclusion of the therapeutic experiment The participants demonstrated loyalty through ongoing communication with the main author seeking feedback on their rehabilitation stages who reach it Notably some participants achieved the significant milestone of walking by standard walker with the assistive device Knee Ankle Foot OrthosisKAFO

The study used Two-way ANOVA repeated measures as a statistical analysis method with effect size and improvement percentage IP as measures and IBM-SPSS statistics processor version 20 for data analysis A statistical significance level of P 005 alpha was used

Results

the means and standard deviations which represented the baseline score for each variable and the results of the variances between study groups for body composition and some anthropometric measures regarding the effectiveness of the HBRP on weight BMI and anthropometric measurements also within groups after 3-month as a primary measure between 3-month 6-month and between primary and secondary measures Table 2 shows no significant differences in variables weight and BMI among the study groups over 6 months Also the measurements of waistabdomen pelvis and thigh circumference did not differ significantly between groups While significant differences were observed in the measures of the right leg F 756 P 005 and the left leg F 812 P 004 The second control group had a larger mean of the right leg Mean 3480 142 and the left leg Mean 3460 162 compared to the experimental group and the first control group

Table 3 shows the variances within groups the effect sizes and improvement percentages There are large effect sizes for HBRP on all variables and the range of IPs indicates a high ratio for anthropometric variables in the Exp group which ranged between 24 - and 162 compared to the other groups As well as the range of effect sizes were 097 - 099 Additionally the primary results show a noticeable improvement in the pelvic circumference as a result of the response to exercise also the change was in an increase the BMI As for the secondary measurements our improvement appeared in the waist circumference in addition to the pelvic circumference and the left thigh circumference in favor of the post-measures The variances between Exp and 1st Con

Tables 4 and 5 show the means and standard deviations which represented the baseline score for each test of muscle strength and the results of the variances between study groups for muscles which work on the lower extremities under the lesion on the head on the trunk and the pelvis The mean differences indicate the increase in the scores of muscle strength with time as a result of the effectiveness of HBRP Also table 4 shows there are significant differences among the Exp 1st Con and 2nd Con groups favor the 2nd Con group in all tests so the P-value was 005 except for the test head elevation from lying-down position which was reported no significant difference among study groups and F2098 P 157 From table 5 the significant differences between Exp and 1st Con group for favor the Exp group in test right knee-hip flexion from lying-down position MD 606 P 005 both knees-hips flexion MD 564 P 001 hip extension from 45 with the ground MD 383 P 014 right lower limb adduction from knee flexed 90from supine MD 297 P 011 and for left lower limb MD 430 P 001 pelvis elevation from open legs-knees-feet based on the ground MD 897 P001 pelvis elevation from close legs-knees-feet based on the ground MD 985 P 000 Also from a supine position the test of both knees extension from 90 MD 435 P 049 right knee extension from 45 MD 468 P 022 left hip flexion MD 1004 P 000

Additionally table 5 shows the variances within groups were significant and the difference sometimes between pre-post1 and post1-post2 tests as a primary result and in most tests of secondary results happened and for a favor the post-tests except within the test of right Knee Extension from 45 and supine position it was not significant Also the effect sizes were large and ranged between η2084 - 095 also the IPs in muscle strength tests favored the Exp group as compared to 1st Con and 2nd Con groups the IPs ranged between 296 - 2428

Discussion The noticeable effect of HBRP was clear on variables studied through large effect sizes and a superior improvement percentage in the Exp group compared with other groups However there were no significant differences in weight BMI and some anthropometric measures over 6 months possibly because of the relatively short duration of HBRP compared to the longer period without rehabilitation Nevertheless significant differences were found in waistabdomen and pelvis measurements before and after the test

A study by Bakkum et al found that a 16-week hand-cycling program for people with chronic SCI reduced waist circumference trunk and Android fat percentage Another study found that individuals with complete injuries had higher weight in paraplegia compared to tetraplegia However some studies state that body mass index may not accurately describe adiposity in SCI individuals Additionally leg lean tissue mass decreased by 151 one year after injury Thus the changes in body composition after injury often involve muscle atrophy and decreased fat-free mass

Differences between study groups were not significant except for the healthy group compared to Exp group and 1st Con group Lack of long-term rehabilitation in SCI individuals led to muscle atrophy and a decline in physical shape as compared to the healthy group SCI individuals had increased body fat mass due to prolonged physical inactivity after injury Jennifer L Maher et al found that exercise likely helps in maintaining or promoting a stable body weight and they concluded that paraplegia results in higher weight than tetraplegia Longer injury duration in tetraplegia was associated with higher waist circumference and weight yet it was not statistically significant this result agrees with the study result Furthermore maintaining ideal weight and BMI is important for SCI individuals and evidence supports the role of chronic exercise in the prevention and treatment of secondary complications associated with dyslipidemia and insulin resistance Exercise likely assists in maintaining a stable body weight or promoting a reduction in body mass although less experimental evidence supports the use of exercise as a monotherapy for weight loss after SCI This has indeed happened with the participants in our study Loss of body mass may be more effectively achieved by combining exercise with caloric restriction and dietary intake with reduced intake of saturated fats Ishimoto et al recommended in their study that routine monitoring of body composition is necessary especially among those with multiple risk factors such as SCI to identify individuals in need of preventive and therapeutic interventions

The aforementioned results show the effectiveness of HBRP through the large effect size values also the IPs were good at the end of HBRP So the clarification of the interpretation of different quantities effect size that the study encompasses several variables and the rehabilitation protocol targets distinct muscle groups integrated with diverse neural networks exerting varying influences on the magnitude of response observed in each participant with SCI contingent upon the severity and the size of their nerves damage which are not the same for participants Consequently the outcomes manifest disparate effect sizes a finding that is substantiated This clarification is confirmed by the Mahalanobis distance D is the multivariate generalization of Cohens d and can be used as a standardized effect size for multivariate differences between groups An important issue in the interpretation of D is heterogeneity that is the extent to which contributions to the overall effect size are concentrated in a small subset of variables rather than evenly distributed across the whole set Here I present two heterogeneity coefficients for D based on the Gini coefficient a well-known index of inequality among values of a distribution In addition significant differences were observed in muscle strength tests which work under the lesion and muscles connecting the lower extremities to the lesion area Despite partial paralysis and varying damage levels the HBRP had a positive impact on muscle strength The study found that HBRP was valuable for individuals with SCIs as it improves their care Concerning rehabilitation at home J Yuen et al showed that most patients found the service of telemedicine was high quality and useful to their care this provides evidence from SCI patients perspective that telemedicine service has an important role in their management Moreover Khorasanizadeh et al concluded that they demonstrated how neurological recovery after TSCI is significantly dependent on injury factors ie severity level and mechanism of injury but is not associated with the type of treatment or country of origin where the treatment is delivered Also studies have shown that regular physical activity is effective in improving fitness in SCI people although most of the evidence is based on relatively short studies focused on paraplegia or tetraplegia individuals Richard-Denis et al concluded in their study that Home-based rehabilitation in selected individuals sustaining an acute AIS-D TSCI is a safe and interesting strategy to optimize the long-term outcome in terms of functional recovery physical as well as to optimize inpatient rehabilitation resources Hicks et al showed that twice-weekly regular exercise training for people with SCI can improve physical Duran et al found that a directed exercise program positively affected mobility strength coordination aerobic resistance and relaxation As well as Ralph et al discovered that motor scores improved based on injury severity within a year Moreover Mohr et al in their study observed a 12 increase in muscle mass after one year of training which partially normalized in all subjects As well as Ji Xubin et al found in their study that the mechanism of exercise training may be connected to the inhibition of the Nogo-NgR signaling pathway to promote neuronal growth as an explanation of development that occurred after rehabilitation Also V L Phillips et al Preliminary evidence suggests that in-home telephone or video-based interventions do improve health-related outcomes for newly injured SCI patients moreover may be cost-saving if program costs are more than offset by a reduction in rehospitalization costs but differential advantages of video-based interventions versus telephone The differences were significant between the Exp group and the 1st Con group in some tests However not all tests showed significant differences due to chronic complications resulting from neglecting rehabilitation for extended periods affecting participants responses The differences were significant within groups for all tests of muscle strength and some anthropometric measures

The impact of the HBRP on muscle groups varies based on the injury level and severity as noted by Kroll et al The 2nd Con group performed better in all tests Participants with high spirits strong will and commitment to the program achieved better results Feigin et al emphasized that individualized management plans and clinical reasoning skills are necessary for each person unique response to treatment Despite facing chronic complications from neglecting rehabilitation the Exp group showed improvement and reduced the risks of various associated complications such as cardiorespiratory issues anemia and urinary tract infections Discontinuing rehabilitation for several years resulted in physical deterioration and adverse psychological and social conditions for participants However individuals with spinal cord injuries face significant challenges in healthcare especially in low-middle-income countries as discussed by Wade Various studies have emphasized the importance of habitual exercise for individuals with SCI as it enhances activity life satisfaction and overall health as concluded by Nash

In this study it is crucial to recognize the constraint imposed by a relatively modest sample size potentially limiting the applicability of the findings to broader populations The implementation of rehabilitation on a large scale mirroring the conditions faced by study participants presents inherent challenges These challenges stem from the requisite involvement of a considerable team of specialized researchers in spinal cord injuries and the logistical intricacies of providing essential resources for in-home rehabilitation all while accommodating diverse environmental conditions Regarding sample selection the study employed a voluntary non-probability sample so the individuals self-selected to participate in the study introducing a potential source of bias and potentially impeding the establishment of causal relationships between the intervention and observed outcomes However this voluntary sample aligns with specific study criteria a common practice in medical research Moreover to comprehensively evaluate the intervention impact diverse outcome measures were employed posing a challenge in isolating specific effects attributable to the intervention To mitigate this challenge the study incorporated control samples from both healthy and affected individuals to control for additional environmental influences over time that could impact the results

Conclusions The HBRP did not demonstrate effectiveness in inducing significant differences in body weight BMI and certain anthropometric measurements between pre- and post-assessments The authors attribute the lack of statistical significance to the brevity of the 6-month intervention period positing that this duration may be insufficient to counteract the prolonged hiatus from rehabilitation experienced by the participants Additionally the challenge posed by the small sample size is acknowledged as a factor influencing the outcomes of such statistical analysis However it did yield a substantial impact on these metrics Moreover there were notable improvements observed after the program Additionally the HBRP has the potential to improve individuals who have been out of regular rehabilitation for several years physically reduce the activity of complications and sometimes even halt their progression Moreover these improvements instilled hope and a renewed sense of purpose motivating them to continue rehabilitation and strive for greater independence and social integration Therefore the authors recommend future work to support prolonged rehabilitation programs for individuals with spinal cord injuries especially those facing interruptions lasting several years This suggestion is based on our study models which indicate the effectiveness of rehabilitation even in cases with prolonged interruptions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None