Intensive Gait Training Rehabilitation Protocol After Sur... | NCT05106114

Studies
Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy

NCT05106114

Sponsor

Fondation Ellen Poidatz

Status

Completed

Last Update Posted

Aug 24, 2025Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

Intensive gait training rehabilitation protocole

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2021Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

May 30, 2024Actual

First Submitted Date

May 28, 2021

First Submission Date that Met QC Criteria

Oct 25, 2021

First Posted Date

Nov 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2025

Last Update Posted Date

Aug 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive gait training rehabilitation protocole	Experimental	Functional gait training Strengthening interventions High intensity interval training	Other: Intensive gait training rehabilitation protocole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive gait training rehabilitation protocole	Other	6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation	Intensive gait training rehabilitation protocole

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Gross Motor Function Measure (GMFM)	Evaluation of Gross motor function	30 minutes
10 meters walking test	Evaluation of walking speed

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel Bams, MD	Medical Doctor	Principal Investigator
Eric Desailly, PhD	Director of research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ellen Poidatz		Saint-Fargeau-Ponthierry		77310	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided