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OpenTrials
Completed

NCT Number: NCT05106114

Intensive Gait Training Rehabilitation Protocol After 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, 77310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive gait training rehabilitation protocole

Other

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

Primary outcomes

  1. 6-minutes walking test

    Time frame: 15 minutes

    Evaluation of walking speed

Secondary outcomes

  1. Gross Motor Function Measure (GMFM)

    Time frame: 30 minutes

    Evaluation of Gross motor function

  2. 10 meters walking test

    Time frame: 5 minutes

    Evaluation of walking speed

  3. Shuttle Run test-I and II

    Time frame: 10 minutes

    Evaluation of aerobic capacity

  4. Muscle strength via a Dynamometer

    Time frame: 15 minutes

    Evaluation of muscle strength

  5. Spatio-temporal gait parameters

    Time frame: 45 minutes

    Cadence, Walking speed, Step Length,Step Time,Step Width

  6. Number of steps per day

    Time frame: one week wearing an accelerometer

  7. Pediatric Quality of Life Inventory (PedSQL)

    Time frame: 10 minutes

    Evaluation of quality of life via a questionnaire

Sponsors and collaborators

Lead sponsor

Fondation Ellen Poidatz

Other

Registry information

Official study title

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

Acronym: ACTIV'MARCHE

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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