NCT06229626 Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
| NCT ID | NCT06229626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hereditary Spastic Paraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-04 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients. This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.
Eligibility Criteria
Inclusion Criteria: * Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene, * Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses), * At least 1 physiotherapy session per week already in place. * Understanding of the protocol * Possibility of connecting to the Internet from home to access video material provided as part of the protocol. Exclusion Criteria: * Botulinum toxin injection within 2 months of protocol inclusion * Discontinuation of private physiotherapy, * Refusal to participate in the protocol, * Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial * Pregnant women * Not affiliated to a social security scheme or beneficiary of such a scheme * Patient under guardianship or trusteeship
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06229626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hereditary Spastic Paraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06229626 currently recruiting?
Yes, NCT06229626 is actively recruiting participants. Contact the research team at pauline.lallemant@icm-institute.org for enrollment information.
Where is the NCT06229626 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06229626 clinical trial?
NCT06229626 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.