Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast

NCT06229626 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2024-04-04

Last updated

2024-11-25

Condition(s) studied

Hereditary Spastic Paraparesis

Investigational drug(s) / intervention(s)

intensive reeducation

intensive reeducation: * 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks * 2 sessions per week at home with video support sent by e-mail for 6 weeks

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group. — 6 weeks
6-minute walk test carried out in the presence of a clinician trained in this test. The patient walks for 6 minutes on a circuit of known distance, identical for each patient. The clinician times the walking time and measures the distance covered during 6 minutes. This test is performed at inclusion and again at 6 weeks

Trial sites (1)

Facility	City	Region	Status
ICM, Hôpital Pitié-Salpêtrière	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06229626 on ClinicalTrials.gov ↗ ← All trials in France