NCT05106114

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

May 28, 2021

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 6-minutes walking test

    Evaluation of walking speed

    15 minutes

Secondary Outcomes (7)

  • Gross Motor Function Measure (GMFM)

    30 minutes

  • 10 meters walking test

    5 minutes

  • Shuttle Run test-I and II

    10 minutes

  • Muscle strength via a Dynamometer

    15 minutes

  • Spatio-temporal gait parameters

    45 minutes

  • +2 more secondary outcomes

Study Arms (1)

Intensive gait training rehabilitation protocole

EXPERIMENTAL

* Functional gait training * Strengthening interventions * High intensity interval training

Other: Intensive gait training rehabilitation protocole

Interventions

6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation

Intensive gait training rehabilitation protocole

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, 77310, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michel Bams, MD

    Medical Doctor

    PRINCIPAL INVESTIGATOR
  • Eric Desailly, PhD

    Director of research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

November 3, 2021

Study Start

May 28, 2021

Primary Completion

December 31, 2023

Study Completion

May 30, 2024

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations