Intensive training program for patients with hereditary spastic paraparesis
Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
This study tests if a 6-week intensive physical rehab program can help people with hereditary spastic paraparesis walk faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06229626 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a 6-week intensive physical rehabilitation program aimed at improving walking speed in patients diagnosed with hereditary spastic paraparesis, specifically the SPG4 genotype. Participants will engage in additional physiotherapy sessions, totaling at least four sessions per week. The study is designed as a prospective, open, randomized trial with a control group to compare outcomes. The goal is to provide objective evidence of the benefits of increased physiotherapy frequency on gait disorders.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed molecular diagnosis of hereditary spastic paraparesis who can walk for 6 minutes with or without assistance.
Not a fit: Patients who have recently received botulinum toxin injections or those who are not currently engaged in physiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the walking ability and quality of life for patients with hereditary spastic paraparesis.
How similar studies have performed: Previous studies have indicated positive outcomes from physiotherapy in managing spasticity, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- ICM, Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Pauline Lallemant, MD
- Email: pauline.lallemant@icm-institute.org
- Phone: 1. 57.27.46.69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.