Cerebral PalsyACTIV'MARCHENCT05106114
Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy
A study testing Intensive gait training rehabilitation protocole in people with Cerebral Palsy, run by Fondation Ellen Poidatz at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intensive gait training rehabilitation protocole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- injuries or pain in lower limbs
- toxines or surgery less than one year before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level 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.
- Conditions
- Cerebral Palsy
- Being tested
- Intensive gait training rehabilitation protocole
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive gait training rehabilitation protocoleOther
6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intensive gait training rehabilitation protocole | Experimental | * Functional gait training
* Strengthening interventions
* High intensity interval training Receives: Other: Intensive gait training rehabilitation protocole |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minutes walking test
Evaluation of walking speed
Measured: 15 minutes
Secondary outcomes (7)
Gross Motor Function Measure (GMFM)
Evaluation of Gross motor function
Measured: 30 minutes
10 meters walking test
Evaluation of walking speed
Measured: 5 minutes
Shuttle Run test-I and II
Evaluation of aerobic capacity
Measured: 10 minutes
Muscle strength via a Dynamometer
Evaluation of muscle strength
Measured: 15 minutes
Spatio-temporal gait parameters
Cadence, Walking speed, Step Length,Step Time,Step Width
Measured: 45 minutes
Number of steps per day
Measured: one week wearing an accelerometer
Pediatric Quality of Life Inventory (PedSQL)
Evaluation of quality of life via a questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start28 May 2021
- Primary completion31 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ellen Poidatz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Bams, MD, Principal investigator, Medical DoctorEric Desailly, PhD, Study director, Director of research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106114
- Sponsor's protocol ID
- RIRCM-P2021-1
- Acronym
- ACTIV'MARCHE
- Status last verified
- Aug 2025
- First submitted
- 28 May 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05106114
- Acronym / sponsor ID
- ACTIV'MARCHE / RIRCM-P2021-1
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondation Ellen PoidatzUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive gait training rehabilitation protocole | Experimental | Other: Intensive gait training rehabilitation protocole* Functional gait training * Strengthening interventions * High intensity interval training |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- injuries or pain in lower limbs
- toxines or surgery less than one year before the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive gait training rehabilitation protocole6 weeks of intensive gait training : 4 weeks at the center and 2 weeks of home-based telerehabilitation | Other | Intensive gait training rehabilitation protocole |
Primary outcome
6-minutes walking test
Time frame: 15 minutes
Evaluation of walking speed
7 secondary outcomes
Gross Motor Function Measure (GMFM)
Time frame: 30 minutes
10 meters walking test
Time frame: 5 minutes
Shuttle Run test-I and II
Time frame: 10 minutes
Muscle strength via a Dynamometer
Time frame: 15 minutes
Spatio-temporal gait parameters
Time frame: 45 minutes
Number of steps per day
Time frame: one week wearing an accelerometer
Pediatric Quality of Life Inventory (PedSQL)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Bams, MD principal investigator
Medical Doctor
Eric Desailly, PhD study director
Director of research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive gait training rehabilitation protocole in people with Cerebral Palsy, run by Fondation Ellen Poidatz at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minutes walking test (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.