Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast (WALK-up)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Hereditary Spastic Paraparesis

Treatments: Other: intensive reeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06229626

APHP230987

Details and patient eligibility

About

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.

Full description

Following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. The hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective.

The main aim of the WALK-UP study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with SPG4 / SPAST-HSP. This is the most frequent genotype in Hereditary Spastic Paraparesis. All patients included in the study will receive at least one physiotherapy session per week in a liberal practice.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

the reeducation group

Experimental group

Description:

The population included in the reeducation group will benefit, in addition to their usual physiotherapy care (at least 1 session per week), from : * 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 These 3 additional video or group sessions will last 30 min. These sessions will be created and adjusted by a physiotherapist and a Physical and Rehabilitation Medicine doctor. They will include exercises such as : * Stretching * posture * Muscle strengthening * Proprioception And will be performed in standing, sitting and lying positions.

Treatment:

Other: intensive reeducation

The control group

No Intervention group

Description:

usual physiotherapy care (at least 1 session per week)