Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533956
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Gait Training Program With Blood Flow Restriction in Children With Cerebral Palsy - EMBRIN Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Programme dEntrainement à la Marche Avec Blood Flow RestrIctioN Chez lEnfant Avec Paralysie cérébrale - EMBRIN Etude Pilote
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
EMBRIN
Brief Summary:
This is a single-center prospective experimental pilot study to assess the feasibility tolerability and effect of a 10-week gait training program combined with simultaneous blood flow restriction BFR on the walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy
The children will receive a 10-week intervention 1 week of habituation without BFR 9 weeks with BFR comprising 3 30-minute treadmill sessions per week At each session the first 5 minutes will enable a gradual increase in speed and then the maximum tolerated walking speed will be sought Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borgs 10-point VAS The rehabilitator will encourage the child to maintain this speed and provide feedback on performance The BFR setting will maintain an occlusion at the root level of both lower limbs of 60 of the total occlusal pressure
Children receiving the 10-week EMBRIN program are expected to improve their walking ability and muscular strength two targets recognized as priorities for individuals with CP by the HAS In this population a major limitation of implementing rehabilitation programs is the large amount of practice required to bring about significant changes This large amount of practice requires a major investment on the part of the individual as well as significant rehabilitation resources Muscle-strengthening programs are also particularly repetitive and therefore not very motivating for children The EMBRIN program could reduce the training load and duration required to impact functional performance in children with CP It could also help reduce the cost of rehabilitation interventions and reduce physical therapy time for individuals with CP in favor of their social participation
The children will receive a 10-week intervention 1 week of habituation without BFR 9 weeks with BFR comprising 3 30-minute treadmill sessions per week At each session the first 5 minutes will enable a gradual increase in speed and then the maximum tolerated walking speed will be sought Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borgs 10-point VAS The rehabilitator will encourage the child to maintain this speed and provide feedback on performance The BFR setting will maintain an occlusion at the root level of both lower limbs of 60 of the total occlusal pressure
Children receiving the 10-week EMBRIN program are expected to improve their walking ability and muscular strength two targets recognized as priorities for individuals with CP by the HAS In this population a major limitation of implementing rehabilitation programs is the large amount of practice required to bring about significant changes This large amount of practice requires a major investment on the part of the individual as well as significant rehabilitation resources Muscle-strengthening programs are also particularly repetitive and therefore not very motivating for children The EMBRIN program could reduce the training load and duration required to impact functional performance in children with CP It could also help reduce the cost of rehabilitation interventions and reduce physical therapy time for individuals with CP in favor of their social participation
Detailed Description:
Context
Cerebral palsy CP is the leading cause of motor disability in children with a prevalence of 177 cases per 1000 births It is defined as a set of permanent developmental disorders of movement and posture resulting from a non-progressive brain lesion affecting a developing brain 60 of individuals with CP have a bilateral form In this group 98 of diplegics and 24 of quadriplegics will be walkers but more often than not with poor walking efficiency In fact these children show not only a reduction in walking speed but also markedly reduced endurance Whats more these children have reduced levels of physical activity resulting in less participation in physical activities throughout their lives Associated with these changes in motor activity CP leads to morphological and architectural changes in the muscles including reduced muscle volume shorter muscle fascicles and increased intramuscular fat These bad adaptations contribute to a reduction in muscle strength and power leading to a progressive decline in functional capacity in adolescence and adulthood associated with a sedentary lifestyle In individuals with CP gait training and muscle strengthening programs carried out separately have shown respectively a relative efficacy in improving walking activity and lower limb muscle strength Rare programs combining these two interventions have been shown to be of interest in mildly affected children In the geriatric population without CP where strengthening with heavy loads may be contraindicated and difficult to implement Blood Flow Restriction BFR training has attracted considerable interest due to its simplicity of use and effectiveness Indeed the application of an inflatable cuff to the proximal part of a limb restricting blood flow combined with low-load muscle strengthening has shown similar effects to high-load strengthening on muscle function BFR was also combined with functional training and this combination showed superiority over functional training alone in improving functional activity BFR does not appear to cause side-effects in typical adolescents and has never been studied in children with CP
Objectives and evaluation criteria
Primary objective to study the effect of a 10-week gait training program combined with simultaneous blood flow restriction BFR using a commercially available device on the walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy To this end a comparison of patients walking speed will be carried out between the period D-70 to D0 standard rehabilitation and the period D0 to D70 walking training program BFR Walking speed will be assessed by the 10-meter walk test The evaluation criterion is the change in walking speed between D-70-J0 and D0-J70
Secondary objectives and evaluation criteria
To assess the effect of this gait training program combined with BFR on the following levels of the International Classification of Functioning and Disability
Functions
Isometric strength of plantar flexors knee extended and flexed by electronic hand dynamometer DEM
Isometric strength of knee flexors and extensors by DEM
Isometric strength of hip abductors by DEM
Pain intensity by numerical rating scale NRS-11 somato sensory function
Activities
Walking endurance by 6-minute walk test
Spontaneous and maximum walking speeds using the 10-meter walk test
Global motor activity via Gross Motor Function Measure - 66 GMFM-66
Spatial gait parameters stride length step length base of support step angle and temporal gait parameters speed and normalized speed cadence percentage of right and left support phase right and left cycle time and double support time Gaitrite
Participation
Achievement of functional goals in terms of performance and satisfaction using the Canadian Occupational Performance Measure COPM
Achievement of daily activities and mobility using the Pediatric Evaluation of Disability Inventory as a computer adaptive test PEDI-CAT
Evaluate the feasibility of this gait training program associated with BFR Feasibility will be assessed by analyzing the percentage of children completing 80 of the training program
To evaluate the tolerance of the EMBRIN program of this gait training program associated with BFR Tolerance to the training program will be studied by assessing pain before during and after gait training with the NRS-11 scale 23 as well as by notifying the occurrence of intercurrent medical events or complications The evaluation criteria are
Change in NRS-11 pain score during gait training sessions
The occurrence of intercurrent medical events or complications
Evaluate participant satisfaction using the CSQ-8 satisfaction questionnaire
Research scheme and progress This is a single-center prospective experimental pilot study designed to assess the feasibility tolerability and effect of a 10-week gait training program combined with simultaneous blood flow restriction BFR on the walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy The children will receive a 10-week intervention 1 week of habituation without BFR 9 weeks with BFR comprising 3 30-minute treadmill sessions per week At each session the first 5 minutes will enable a gradual increase in speed and then the maximum tolerated walking speed will be sought Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borgs 10-point VAS The rehabilitator will encourage the child to maintain this speed and provide feedback on performance The BFR setting will maintain an occlusion at the root level of both lower limbs of 60 of the total occlusal pressure
During each session pain will be assessed using the NRS-11 before the restriction is placed after 15 minutes of walking and within 5 minutes of the restriction being removed In the event of participant request or premature termination of the session a pain assessment will be added A pain assessment will also be carried out 24 hours after the training session
Functional assessments carried out at baseline at T0 D0-70d and T1 D0 will explore the usual evolution of walking speed in children receiving usual care Assessments at T2 D035d will explore the evolution of variables of interest halfway through the intervention period Evaluations at T3 D070d will assess the immediate effects of therapy Functional assessments will be carried out again at T4 D0100d and T5 D0160 to evaluate the medium-term effect of therapy
Research duration Inclusion period 24 months Duration of participation 8 months maximum Study duration 32 months
Cerebral palsy CP is the leading cause of motor disability in children with a prevalence of 177 cases per 1000 births It is defined as a set of permanent developmental disorders of movement and posture resulting from a non-progressive brain lesion affecting a developing brain 60 of individuals with CP have a bilateral form In this group 98 of diplegics and 24 of quadriplegics will be walkers but more often than not with poor walking efficiency In fact these children show not only a reduction in walking speed but also markedly reduced endurance Whats more these children have reduced levels of physical activity resulting in less participation in physical activities throughout their lives Associated with these changes in motor activity CP leads to morphological and architectural changes in the muscles including reduced muscle volume shorter muscle fascicles and increased intramuscular fat These bad adaptations contribute to a reduction in muscle strength and power leading to a progressive decline in functional capacity in adolescence and adulthood associated with a sedentary lifestyle In individuals with CP gait training and muscle strengthening programs carried out separately have shown respectively a relative efficacy in improving walking activity and lower limb muscle strength Rare programs combining these two interventions have been shown to be of interest in mildly affected children In the geriatric population without CP where strengthening with heavy loads may be contraindicated and difficult to implement Blood Flow Restriction BFR training has attracted considerable interest due to its simplicity of use and effectiveness Indeed the application of an inflatable cuff to the proximal part of a limb restricting blood flow combined with low-load muscle strengthening has shown similar effects to high-load strengthening on muscle function BFR was also combined with functional training and this combination showed superiority over functional training alone in improving functional activity BFR does not appear to cause side-effects in typical adolescents and has never been studied in children with CP
Objectives and evaluation criteria
Primary objective to study the effect of a 10-week gait training program combined with simultaneous blood flow restriction BFR using a commercially available device on the walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy To this end a comparison of patients walking speed will be carried out between the period D-70 to D0 standard rehabilitation and the period D0 to D70 walking training program BFR Walking speed will be assessed by the 10-meter walk test The evaluation criterion is the change in walking speed between D-70-J0 and D0-J70
Secondary objectives and evaluation criteria
To assess the effect of this gait training program combined with BFR on the following levels of the International Classification of Functioning and Disability
Functions
Isometric strength of plantar flexors knee extended and flexed by electronic hand dynamometer DEM
Isometric strength of knee flexors and extensors by DEM
Isometric strength of hip abductors by DEM
Pain intensity by numerical rating scale NRS-11 somato sensory function
Activities
Walking endurance by 6-minute walk test
Spontaneous and maximum walking speeds using the 10-meter walk test
Global motor activity via Gross Motor Function Measure - 66 GMFM-66
Spatial gait parameters stride length step length base of support step angle and temporal gait parameters speed and normalized speed cadence percentage of right and left support phase right and left cycle time and double support time Gaitrite
Participation
Achievement of functional goals in terms of performance and satisfaction using the Canadian Occupational Performance Measure COPM
Achievement of daily activities and mobility using the Pediatric Evaluation of Disability Inventory as a computer adaptive test PEDI-CAT
Evaluate the feasibility of this gait training program associated with BFR Feasibility will be assessed by analyzing the percentage of children completing 80 of the training program
To evaluate the tolerance of the EMBRIN program of this gait training program associated with BFR Tolerance to the training program will be studied by assessing pain before during and after gait training with the NRS-11 scale 23 as well as by notifying the occurrence of intercurrent medical events or complications The evaluation criteria are
Change in NRS-11 pain score during gait training sessions
The occurrence of intercurrent medical events or complications
Evaluate participant satisfaction using the CSQ-8 satisfaction questionnaire
Research scheme and progress This is a single-center prospective experimental pilot study designed to assess the feasibility tolerability and effect of a 10-week gait training program combined with simultaneous blood flow restriction BFR on the walking speed of children aged 8 to 18 with bilateral spastic cerebral palsy The children will receive a 10-week intervention 1 week of habituation without BFR 9 weeks with BFR comprising 3 30-minute treadmill sessions per week At each session the first 5 minutes will enable a gradual increase in speed and then the maximum tolerated walking speed will be sought Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borgs 10-point VAS The rehabilitator will encourage the child to maintain this speed and provide feedback on performance The BFR setting will maintain an occlusion at the root level of both lower limbs of 60 of the total occlusal pressure
During each session pain will be assessed using the NRS-11 before the restriction is placed after 15 minutes of walking and within 5 minutes of the restriction being removed In the event of participant request or premature termination of the session a pain assessment will be added A pain assessment will also be carried out 24 hours after the training session
Functional assessments carried out at baseline at T0 D0-70d and T1 D0 will explore the usual evolution of walking speed in children receiving usual care Assessments at T2 D035d will explore the evolution of variables of interest halfway through the intervention period Evaluations at T3 D070d will assess the immediate effects of therapy Functional assessments will be carried out again at T4 D0100d and T5 D0160 to evaluate the medium-term effect of therapy
Research duration Inclusion period 24 months Duration of participation 8 months maximum Study duration 32 months
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