Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645795
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Robot Asissted Training on Neurodevelopmental Alterations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Physiotherapy Based on Robot Assited Gait Training on Body Composition and Functional Variables in Pediatric Patient With Neurodevelopmental Alterations Randomized and Crossover Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAGTNEUDEV
Brief Summary:
The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disordersThe main questions to answer are
Does this treatment improve body composition parameters
Does the treatment help maintaining functionality and without causing discomfort or pain
Participants will perform 2 weekly physiotherapy sessions for 8 weeks then there will be 4 weeks of washout afer which each patient will cross over to the other group for 8 more weeks
Does this treatment improve body composition parameters
Does the treatment help maintaining functionality and without causing discomfort or pain
Participants will perform 2 weekly physiotherapy sessions for 8 weeks then there will be 4 weeks of washout afer which each patient will cross over to the other group for 8 more weeks
Detailed Description:
Pediatric population with neurodevelopmental disorders such as cerebral palsy CP levels IV-V of the Gross Motor Function Classification System GMFCS do not walk independently due to their significant physical limitations so their body composition may be altered which in turn affects their functional level and may lead to the appearance of musculoskeletal complications Robot assisted gait training RAGT offers a new opportunity to improve mobility of pediatric population with CP levels IV-V of GMFCS although scientific literature is still scarce in this population
The main aim of this study is to determine the effect of RAGT on body composition and functional variables in a pediatric population with neurodevelopmental disorders Also to analyze changes in functional musculoeskeletal and stress biomarkers variables after the intervention and to evaluate the cardiorespiratory adaptation to the RAGT
A convenience sample of 10-12 participants will be selected who will serve as their own control It has been taken into account that previous studies conducted on pediatric population with CP this sample size is adequate
At the beginning of the study 50 of the participants will be part of the RAGT group which will perform 2 weekly sessions of RAGT plus conventional therapy and the other 50 will belong to the conventional physical therapy group The study consists of phases 1 and 2 of treatment with a washout period between phases after phase 1 8 weeks of therapy in one of the two groups there will be 4 weeks of washout after which each patient will cross over to the other group in phase 2 for 8 weeks
Participants will be assessed before phase 1 T1 after phase 1 T2 before phase 2 T3 and after phase 2 T4
The main aim of this study is to determine the effect of RAGT on body composition and functional variables in a pediatric population with neurodevelopmental disorders Also to analyze changes in functional musculoeskeletal and stress biomarkers variables after the intervention and to evaluate the cardiorespiratory adaptation to the RAGT
A convenience sample of 10-12 participants will be selected who will serve as their own control It has been taken into account that previous studies conducted on pediatric population with CP this sample size is adequate
At the beginning of the study 50 of the participants will be part of the RAGT group which will perform 2 weekly sessions of RAGT plus conventional therapy and the other 50 will belong to the conventional physical therapy group The study consists of phases 1 and 2 of treatment with a washout period between phases after phase 1 8 weeks of therapy in one of the two groups there will be 4 weeks of washout after which each patient will cross over to the other group in phase 2 for 8 weeks
Participants will be assessed before phase 1 T1 after phase 1 T2 before phase 2 T3 and after phase 2 T4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None