Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy (ACTIV'MARCHE)

August 19, 2025 updated by: Fondation Ellen Poidatz

Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy

In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Fargeau-Ponthierry, France, 77310
        • Fondation Ellen Poidatz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cerebral palsy
  • Age between 10 and 20 years
  • Single-Event multi-level surgery more than one year ago
  • GMFCS I to III
  • Capacity to understand simple instructions
  • Volontary consent

Exclusion Criteria:

  • injuries or pain in lower limbs
  • toxines or surgery less than one year before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive gait training rehabilitation protocole
  • Functional gait training
  • Strengthening interventions
  • High intensity interval training
Other: Intensive gait training rehabilitation protocole
6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minutes walking test
Time Frame: 15 minutes
Evaluation of walking speed
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM)
Time Frame: 30 minutes
Evaluation of Gross motor function
30 minutes
10 meters walking test
Time Frame: 5 minutes
Evaluation of walking speed
5 minutes
Shuttle Run test-I and II
Time Frame: 10 minutes
Evaluation of aerobic capacity
10 minutes
Muscle strength via a Dynamometer
Time Frame: 15 minutes
Evaluation of muscle strength
15 minutes
Spatio-temporal gait parameters
Time Frame: 45 minutes
Cadence, Walking speed, Step Length,Step Time,Step Width
45 minutes
Number of steps per day
Time Frame: one week wearing an accelerometer
one week wearing an accelerometer
Pediatric Quality of Life Inventory (PedSQL)
Time Frame: 10 minutes
Evaluation of quality of life via a questionnaire
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ellen Poidatz

Investigators

  • Principal Investigator: Michel Bams, MD, Medical Doctor
  • Study Director: Eric Desailly, PhD, Director of research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIRCM-P2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe