Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy

NCT04837105 | Recruiting

• 1 other identifier: ARROW CP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Keywords

physiotherapy; gait rehabilitation; serious game; multi level surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  6 minutes

Secondary Outcomes (3)

• Muscle power sprint test

  10 minutes

• Shuttle run test I and II (adapted for children with CP)

  20 minutes

• Questionnaire (PACES)

  10 minutes

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.)

Other: Treadmill

Test group

EXPERIMENTAL

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.)

Other: Serious game ARROW CP

Interventions

Serious game ARROW CP OTHER

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".

Test group

Treadmill OTHER

Participant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)

Control group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A clinical diagnosis of CP mentioned in the medical record
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ellen Poidatz: lead

Study Sites (1)

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, Île-de-France Region, 77310, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36216413 DERIVED

Related Links

• Fondation Ellen Poidatz ARROW CP

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pre-test and post-test evaluation are made by one physiotherapist ignoring the patient's arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control trial - 2 groups

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)