Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444672
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-11
Brief Title:
Effects of a Home-Based Rehabilitation on Anthropometric Measures Sensory-Motor Functions and Independence After Spinal Cord Injury
Sponsor:
University of Mosul
Organization:
University of Mosul
Study Overview
Official Title:
Effects of a Home-Based Rehabilitation on Anthropometric Measures Sensory-Motor Functions and Independence After Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2024-05
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:
HBRSCI
Brief Summary:
Background The scarcity of resources for spinal cord injury SCI rehabilitation constitutes a significant obstacle particularly in war-torn regions experiencing a rise in such injuries Implementing a home-based rehabilitative program HBRP tailored to patients environmental social and financial contexts is crucial in mitigating this challenge The authors investigated the effects of a 24-month HBRP on anthropometric measurements muscular strength sensory and motor function and independence in participants transitioning from bed to walking following SCI
Methods Serial case study in a quasi-experimental design the conducting was at the participants homes The participants were four patients with SCI experimental group and another two patients with SCI control group The interventions were a 24-month HBRP comprising strength flexibility and balance training the outcome measures involved anthropometric measurements muscle strength using a digital handheld dynamometer muscle thickness and cross-sectional area measured using magnetic resonance imaging measured five walking tests and the American Spinal Injury Association scale ASIA score for assess the sensory and motor score and the Spinal Cord Independence Measure SCIM
Methods Serial case study in a quasi-experimental design the conducting was at the participants homes The participants were four patients with SCI experimental group and another two patients with SCI control group The interventions were a 24-month HBRP comprising strength flexibility and balance training the outcome measures involved anthropometric measurements muscle strength using a digital handheld dynamometer muscle thickness and cross-sectional area measured using magnetic resonance imaging measured five walking tests and the American Spinal Injury Association scale ASIA score for assess the sensory and motor score and the Spinal Cord Independence Measure SCIM
Detailed Description:
Materials and Methods
The primary condition being studied
Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No SensoryMotor in S4-5
Participants
From NRCODP the authors accessed six participants with SCIs who participated voluntarily in this study three males and one female their mean age was 2475 years Those patients constituted the experimental group Their injuries were classified as grade A according to the American Spinal Injury Association ASIA scale Spinal cord damage was observed at T6 T8 L1 and L2 The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months The control group comprised two volunteers mean age 2350 years with SCIs at T9 and L1 These patients only served as a comparison for magnetic resonance imaging MRI findings
This study was a case series that included a home-based therapeutic exercise program Strength and ASIA- scales were assessed every 6 months The walking evaluation was performed monthly for 10 months after the participants began using assistive devices The final assessment was conducted at 24 months
Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement The HBRP included whole-body training with various exercises for stretching strength endurance and aerobic fitness The treatment sessions were performed three times per week and had a 50-120-minute duration The exercises were modified based on individual progress and included using a rubber ball for balance and strength as well as trunk flexibility static balance stability and standing exercises Participants who could stand with assistive devices such as knee-ankle-foot orthoses KAFO performed walking exercises During the 24 months the program encountered technical obstacles during implementation primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety especially during the first 6 months Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square employing safety belts maintaining a safe distance and involving participants relatives for assistance especially during the introduction of new and challenging motor tasks Participants families either purchased or received exercise equipment and some devices were locally manufactured based on standard specifications Participants facing negative psychological states due to motor challenges and monotony received psychological faith-based encouraging and entertaining interventions incorporating real-life success stories through video observations of individuals with SCIs During the 24 months the program encountered technical obstacles during implementation primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety especially during the first 6 months However precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square employing safety belts maintaining a safe distance and involving participants relatives for assistance especially during the introduction of new and challenging motor tasks Participants families either purchased or received exercise equipment and some devices were locally manufactured based on standard specifications Participants facing negative psychological states due to motor challenges and monotony received psychological faith-based encouraging and entertaining interventions incorporating real-life success stories through video observations of individuals with SCIs
Walking tests The 10-m walk test WT 2-min WT 2MWT 4MWT 6MWT and Up GO WT were used when the participants reached the walking phase These tests were used to assess walking speed improvement and endurance in patients with SCI The investigators chose wide suitable areas at participants homes for walking assessments to adhere to test prerequisites Essential equipment including markers denoting starting and concluding points was supplied and distinguished Remember the following text by colorful stickers stopwatches and measuring tapes Further safety protocols were implemented to safeguard participants during test execution and all tests were carried out according to the relevant standards
In addition a kinesthetic analysis approach was used in which mental visualization played a pivotal role in patients who lack a sense of balance Locally manufactured assistive devices eg KAFO were used and coordination between doctors and the author ensured effective treatment and successful rehabilitation
Outcome measures Anthropometric measurements including the abdominal pelvic thigh and leg circumference were taken using a tape measure Weight and height were measured using traditional scales Patient measurements weight body mass index BMI and anthropometric measurements were monitored every 6 months throughout the intervention period The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months The pre-HRBP and 24-month values were also compared In addition muscle strength was measured using a Micro-FET2 dynamometer Hoggan Scientific LLC Salt Lake City UT where the participants exerted maximum force against the device while the examiner provided resistance The tests lasted a few seconds and were signalled by the commands go and relax The Spinal Cord Independence Measure SCIM includes the self-care 0-20 respiration and sphincter management 0-40 and mobility 0-40 sub-scores Each area is scored according to its proportional weight in these patients general activity The final score ranges from 0 to 100 with a high score indicating higher independence the authors assess the independence of participants during the 24 months of rehabilitation
Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 15 T MRI scanner Elekta Unity Philips Stockholm Sweden which is a modified 15 T Philips Ingenia Best The Netherlands Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume and anatomical cross-sectional area CSA focusing on the rectus femoris RF and gluteus maximus GM muscles Additionally the MRIs included muscle thickness MT in mm and CSA measurements for the bilateral RF and GM muscles These measurements were repeated 8-9 months after the start of standing and walking training Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization
During MRI analysis the initial peak corresponds to muscle density while the subsequent peak indicates fat density and the midpoint between these peaks delineates muscle from fat pixels Calculations of CSAs were performed using the equations outlined by Gorge and Dudley Muscle CSA cm2 ¼ of the total number of muscle pixels field of view FOV matrix size2 and Intramuscular Fat IMF CSA cm2 ¼ of the total number of IMF pixels FOV matrix size2 To normalize for skeletal muscle size discrepancies across groups IMF CSA was expressed relative to skeletal muscle CSA Relative IMF ¼ of IMF CSA muscle CSA 100
Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance The ES was quantified by Cohens criteria Additionally paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores SPSS version 240 IBM Corp Armonk NY USA was used for all analyses An alpha value 005 indicated statistical significance
The primary condition being studied
Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No SensoryMotor in S4-5
Participants
From NRCODP the authors accessed six participants with SCIs who participated voluntarily in this study three males and one female their mean age was 2475 years Those patients constituted the experimental group Their injuries were classified as grade A according to the American Spinal Injury Association ASIA scale Spinal cord damage was observed at T6 T8 L1 and L2 The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months The control group comprised two volunteers mean age 2350 years with SCIs at T9 and L1 These patients only served as a comparison for magnetic resonance imaging MRI findings
This study was a case series that included a home-based therapeutic exercise program Strength and ASIA- scales were assessed every 6 months The walking evaluation was performed monthly for 10 months after the participants began using assistive devices The final assessment was conducted at 24 months
Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement The HBRP included whole-body training with various exercises for stretching strength endurance and aerobic fitness The treatment sessions were performed three times per week and had a 50-120-minute duration The exercises were modified based on individual progress and included using a rubber ball for balance and strength as well as trunk flexibility static balance stability and standing exercises Participants who could stand with assistive devices such as knee-ankle-foot orthoses KAFO performed walking exercises During the 24 months the program encountered technical obstacles during implementation primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety especially during the first 6 months Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square employing safety belts maintaining a safe distance and involving participants relatives for assistance especially during the introduction of new and challenging motor tasks Participants families either purchased or received exercise equipment and some devices were locally manufactured based on standard specifications Participants facing negative psychological states due to motor challenges and monotony received psychological faith-based encouraging and entertaining interventions incorporating real-life success stories through video observations of individuals with SCIs During the 24 months the program encountered technical obstacles during implementation primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety especially during the first 6 months However precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square employing safety belts maintaining a safe distance and involving participants relatives for assistance especially during the introduction of new and challenging motor tasks Participants families either purchased or received exercise equipment and some devices were locally manufactured based on standard specifications Participants facing negative psychological states due to motor challenges and monotony received psychological faith-based encouraging and entertaining interventions incorporating real-life success stories through video observations of individuals with SCIs
Walking tests The 10-m walk test WT 2-min WT 2MWT 4MWT 6MWT and Up GO WT were used when the participants reached the walking phase These tests were used to assess walking speed improvement and endurance in patients with SCI The investigators chose wide suitable areas at participants homes for walking assessments to adhere to test prerequisites Essential equipment including markers denoting starting and concluding points was supplied and distinguished Remember the following text by colorful stickers stopwatches and measuring tapes Further safety protocols were implemented to safeguard participants during test execution and all tests were carried out according to the relevant standards
In addition a kinesthetic analysis approach was used in which mental visualization played a pivotal role in patients who lack a sense of balance Locally manufactured assistive devices eg KAFO were used and coordination between doctors and the author ensured effective treatment and successful rehabilitation
Outcome measures Anthropometric measurements including the abdominal pelvic thigh and leg circumference were taken using a tape measure Weight and height were measured using traditional scales Patient measurements weight body mass index BMI and anthropometric measurements were monitored every 6 months throughout the intervention period The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months The pre-HRBP and 24-month values were also compared In addition muscle strength was measured using a Micro-FET2 dynamometer Hoggan Scientific LLC Salt Lake City UT where the participants exerted maximum force against the device while the examiner provided resistance The tests lasted a few seconds and were signalled by the commands go and relax The Spinal Cord Independence Measure SCIM includes the self-care 0-20 respiration and sphincter management 0-40 and mobility 0-40 sub-scores Each area is scored according to its proportional weight in these patients general activity The final score ranges from 0 to 100 with a high score indicating higher independence the authors assess the independence of participants during the 24 months of rehabilitation
Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 15 T MRI scanner Elekta Unity Philips Stockholm Sweden which is a modified 15 T Philips Ingenia Best The Netherlands Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume and anatomical cross-sectional area CSA focusing on the rectus femoris RF and gluteus maximus GM muscles Additionally the MRIs included muscle thickness MT in mm and CSA measurements for the bilateral RF and GM muscles These measurements were repeated 8-9 months after the start of standing and walking training Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization
During MRI analysis the initial peak corresponds to muscle density while the subsequent peak indicates fat density and the midpoint between these peaks delineates muscle from fat pixels Calculations of CSAs were performed using the equations outlined by Gorge and Dudley Muscle CSA cm2 ¼ of the total number of muscle pixels field of view FOV matrix size2 and Intramuscular Fat IMF CSA cm2 ¼ of the total number of IMF pixels FOV matrix size2 To normalize for skeletal muscle size discrepancies across groups IMF CSA was expressed relative to skeletal muscle CSA Relative IMF ¼ of IMF CSA muscle CSA 100
Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance The ES was quantified by Cohens criteria Additionally paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores SPSS version 240 IBM Corp Armonk NY USA was used for all analyses An alpha value 005 indicated statistical significance
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