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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive gait training rehabilitation protocole
Sponsored by
Fondation Ellen Poidatz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ellen PoidatzRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensive gait training rehabilitation protocole

Arm Description

Functional gait training Strengthening interventions High intensity interval training

Outcomes

Primary Outcome Measures

6-minutes walking test
Evaluation of walking speed

Secondary Outcome Measures

Gross Motor Function Measure (GMFM)
Evaluation of Gross motor function
10 meters walking test
Evaluation of walking speed
Shuttle Run test-I and II
Evaluation of aerobic capacity
Muscle strength via a Dynamometer
Evaluation of muscle strength
Spatio-temporal gait parameters
Cadence, Walking speed, Step Length,Step Time,Step Width
Number of steps per day
Pediatric Quality of Life Inventory (PedSQL)
Evaluation of quality of life via a questionnaire

Full Information

First Posted
May 28, 2021
Last Updated
February 14, 2023
Sponsor
Fondation Ellen Poidatz
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1. Study Identification

Unique Protocol Identification Number
NCT05106114
Brief Title
Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy
Acronym
ACTIV'MARCHE
Official Title
Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive gait training rehabilitation protocole
Arm Type
Experimental
Arm Description
Functional gait training Strengthening interventions High intensity interval training
Intervention Type
Other
Intervention Name(s)
Intensive gait training rehabilitation protocole
Intervention Description
6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation
Primary Outcome Measure Information:
Title
6-minutes walking test
Description
Evaluation of walking speed
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM)
Description
Evaluation of Gross motor function
Time Frame
30 minutes
Title
10 meters walking test
Description
Evaluation of walking speed
Time Frame
5 minutes
Title
Shuttle Run test-I and II
Description
Evaluation of aerobic capacity
Time Frame
10 minutes
Title
Muscle strength via a Dynamometer
Description
Evaluation of muscle strength
Time Frame
15 minutes
Title
Spatio-temporal gait parameters
Description
Cadence, Walking speed, Step Length,Step Time,Step Width
Time Frame
45 minutes
Title
Number of steps per day
Time Frame
one week wearing an accelerometer
Title
Pediatric Quality of Life Inventory (PedSQL)
Description
Evaluation of quality of life via a questionnaire
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Desailly, PhD
Phone
0160658282
Ext
0033
Email
eric.desailly@fondationpoidatz.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Hinnekens, Master
Phone
0160658282
Ext
0033
Email
elodie.hinnekens@fondationpoidatz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bams, MD
Organizational Affiliation
Medical Doctor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Desailly, PhD
Organizational Affiliation
Director of research
Official's Role
Study Director
Facility Information:
Facility Name
Fondation Ellen Poidatz
City
Saint-Fargeau-Ponthierry
ZIP/Postal Code
77310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Desailly, PhD
Phone
160658282
Ext
0033
Email
eric.desailly@fondationpoidatz.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy

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