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

NCT ID: NCT06229626

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2026-10-31

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.

Detailed 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.

Conditions

Hereditary Spastic Paraparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the reeducation group

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.

Group Type: EXPERIMENTAL

intensive reeducation

Intervention Type: OTHER

• 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

The control group

usual physiotherapy care (at least 1 session per week)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICM, Hôpital Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline Lallemant, MD

Role: CONTACT

pauline.lallemant@icm-institute.org

1. 57.27.46.69 ext. +33

Rania Hilab, CRA

Role: CONTACT

rania.hilab@icm-institute.org

1. 57.27.46.91 ext. +33

Facility Contacts

Pauline Lallemant, MD

Role: primary

pauline.lallemant@icm-institute.org

1. 57.27.46.69 ext. +33

Rania Hilab, CRA

Role: backup

rania.hilab@icm-institute.org

1. 57.27.46.91 ext. +33

Pauline Lallemant, MD

Role: backup

Other Identifiers

APHP230987

Identifier Type: -

Identifier Source: org_study_id