Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy

Cerebral Palsy Clinical Trial

— ACTIV'MARCHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106114
• Other study ID #: RIRCM-P2021-1
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2023
• Source: Fondation Ellen Poidatz
• Contact: Eric Desailly, PhD
• Phone: 0160658282
• Email: eric.desailly[@]fondationpoidatz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Intensive gait training rehabilitation protocole
6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation

Locations

Country	Name	City	State
France	Fondation Ellen Poidatz	Saint-Fargeau-Ponthierry

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ellen Poidatz

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minutes walking test	Evaluation of walking speed	15 minutes
Secondary	Gross Motor Function Measure (GMFM)	Evaluation of Gross motor function	30 minutes
Secondary	10 meters walking test	Evaluation of walking speed	5 minutes
Secondary	Shuttle Run test-I and II	Evaluation of aerobic capacity	10 minutes
Secondary	Muscle strength via a Dynamometer	Evaluation of muscle strength	15 minutes
Secondary	Spatio-temporal gait parameters	Cadence, Walking speed, Step Length,Step Time,Step Width	45 minutes
Secondary	Number of steps per day		one week wearing an accelerometer
Secondary	Pediatric Quality of Life Inventory (PedSQL)	Evaluation of quality of life via a questionnaire	10 minutes