Back to resultsSerious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Gait Disorders, Neurologic
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game ARROW CP
Treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring physiotherapy, gait rehabilitation, serious game, multi level surgery
Eligibility Criteria
Inclusion Criteria:
- A clinical diagnosis of CP mentioned in the medical record
- Minor child for the entire duration of the protocol, i.e. between 10 and 17 years of age (the child must be less than 18 years of age at the time of the last check-up scheduled 1 year after inclusion in the study)
- Global Motor Function Classification System (GMFCS) levels I to III
- Functional Mobility Scale 50 meters rating superior or equal to 2 (ability to walk on 50m using a walker or frame without help from another person)
- Ability to cooperate, understand and follow simple instructions to play.
- Patient affiliated to the French social security system
- Voluntary patient whose parents have given their consent for their child to participate in the study
- Patient who has undergone multisite surgery of the lower limbs including bone procedures at least 7 weeks before the start of the procedure
Exclusion Criteria:
- A diagnosis of photosensitive epilepsy mentioned in the medical file AND/OR a mention in the child's medical file or by the parents or by the child of a history of epileptic seizures occurring during the practice of a video game
- A visual, cognitive or auditory impairment at a level that would interfere with playing the game. The patient must have normal or corrected vision and hearing.
Sites / Locations
- Fondation Ellen PoidatzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Test group
Arm Description
Classic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3*/week/4weeks: 5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed. (protocol from Grecco et al.)
Classic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3*/week/4weeks: walking sprint session at maximal speed with gradual increase in number of repetitions over the weeks. (protocol from Verschuren et al.)
Outcomes
Primary Outcome Measures
6 minutes walking test
Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length).
Procedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
Secondary Outcome Measures
Muscle power sprint test
Aim of the measurement: To assess the anaerobic capacity of children with motor disabilities.
Procedure: The patient is asked to perform six 15-metre walking sprints, with 10 seconds of rest between each sprint. The average and maximum power are calculated based on the speeds achieved during the sprints.
Shuttle run test I and II (adapted for children with CP)
In this test, the child must walk between 2 poles spaced 10 metres apart following the "beep rhythm" imposed by a pre-recorded soundtrack. The soundtrack includes an increase in walking speed of 0.25 km/h every minute.
(Verschuren et al.)
Questionnaire (PACES)
To assess enjoyment for both control and test group, the 16-items of the Physical Activity Enjoyment Scale (PACES) will be used. The PACES is a valid and re- liable measure of physical activity enjoyment. It has been used in many studies assessing the effectiveness of VR therapy This questionnaire will be presented to the participant at the end of the last session.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04837105
Brief Title
Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
Official Title
Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ellen Poidatz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery.
The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.
Detailed Description
This study is a randomized control trial.
Participants are children with cerebral palsy having a single event multi level surgery. They are involving in a rehabilitation protocol in the same rehab center.
Two groups are formed:
control group: classic rehab+children have treadmill gait protocol during 4 weeks
test group : classic rehab+children have gait training with the ARROW CP serious game.
ARROW CP game is developed for augmented reality headset (Microsoft Hololens). It delivers feedback in real time and with delay on participant gait performance. This game has been developed by researchers (Fondation Ellen Poidatz, France).
The aims of this study are:
. To determine the impact on spatiotemporal gait parameters of intensive gait rehabilitation involving the use of a serious AR game in children and adolescents with cerebral palsy.
To explore the effects of playing a serious game on functional abilities
To assess motivation, satisfaction and adherence to treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gait Disorders, Neurologic
Keywords
physiotherapy, gait rehabilitation, serious game, multi level surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial - 2 groups
Masking
Outcomes Assessor
Masking Description
Pre-test and post-test evaluation are made by one physiotherapist ignoring the patient's arm.
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Classic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3*/week/4weeks:
5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed.
(protocol from Grecco et al.)
Arm Title
Test group
Arm Type
Experimental
Arm Description
Classic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3*/week/4weeks:
walking sprint session at maximal speed with gradual increase in number of repetitions over the weeks.
(protocol from Verschuren et al.)
Intervention Type
Other
Intervention Name(s)
Serious game ARROW CP
Intervention Description
ARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during "sprint session".
Intervention Type
Other
Intervention Name(s)
Treadmill
Intervention Description
Participant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)
Primary Outcome Measure Information:
Title
6 minutes walking test
Description
Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length).
Procedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Muscle power sprint test
Description
Aim of the measurement: To assess the anaerobic capacity of children with motor disabilities.
Procedure: The patient is asked to perform six 15-metre walking sprints, with 10 seconds of rest between each sprint. The average and maximum power are calculated based on the speeds achieved during the sprints.
Time Frame
10 minutes
Title
Shuttle run test I and II (adapted for children with CP)
Description
In this test, the child must walk between 2 poles spaced 10 metres apart following the "beep rhythm" imposed by a pre-recorded soundtrack. The soundtrack includes an increase in walking speed of 0.25 km/h every minute.
(Verschuren et al.)
Time Frame
20 minutes
Title
Questionnaire (PACES)
Description
To assess enjoyment for both control and test group, the 16-items of the Physical Activity Enjoyment Scale (PACES) will be used. The PACES is a valid and re- liable measure of physical activity enjoyment. It has been used in many studies assessing the effectiveness of VR therapy This questionnaire will be presented to the participant at the end of the last session.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of CP mentioned in the medical record
Minor child for the entire duration of the protocol, i.e. between 10 and 17 years of age (the child must be less than 18 years of age at the time of the last check-up scheduled 1 year after inclusion in the study)
Global Motor Function Classification System (GMFCS) levels I to III
Functional Mobility Scale 50 meters rating superior or equal to 2 (ability to walk on 50m using a walker or frame without help from another person)
Ability to cooperate, understand and follow simple instructions to play.
Patient affiliated to the French social security system
Voluntary patient whose parents have given their consent for their child to participate in the study
Patient who has undergone multisite surgery of the lower limbs including bone procedures at least 7 weeks before the start of the procedure
Exclusion Criteria:
A diagnosis of photosensitive epilepsy mentioned in the medical file AND/OR a mention in the child's medical file or by the parents or by the child of a history of epileptic seizures occurring during the practice of a video game
A visual, cognitive or auditory impairment at a level that would interfere with playing the game. The patient must have normal or corrected vision and hearing.
Facility Information:
Facility Name
Fondation Ellen Poidatz
City
Saint-Fargeau-Ponthierry
State/Province
ILE DE France
ZIP/Postal Code
77310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Desailly, PhD
Phone
160652765
Ext
+33
Email
eric.desailly@fondationpoidatz.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36216413
Citation
Guinet AL, Bams M, Payan-Terral S, Khouri N, Otmane S, Bouyer G, Desailly E. Effect of an augmented reality active video game for gait training in children with cerebral palsy following single-event multilevel surgery: protocol for a randomised controlled trial. BMJ Open. 2022 Oct 10;12(10):e061580. doi: 10.1136/bmjopen-2022-061580.
Results Reference
derived
Links:
URL
https://www.fondationpoidatz.com/arrow-cp/
Description
Fondation Ellen Poidatz ARROW CP
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Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
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