Clinical trial NCT06229626: Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
Official title: Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Spastic Paraparesis
Keywords: physical rehabilitation program
hereditary spastic paraparesis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.
timeFrame: 6 weeks
Secondary outcomes:
measure: compare the before-after variation in distance covered in 6 minutes
timeFrame: 18 weeks
measure: compare the before-after variation in walking speed over a 10-meters test
timeFrame: 18 weeks
measure: compare the clinical evolution of spasticity
timeFrame: 18 weeks
measure: compare the lower-limb joint amplitudes
timeFrame: 18 weeks
measure: compare the patients' mood evolution
timeFrame: 18 weeks
measure: compare the evolution of cognitive disorders
timeFrame: 18 weeks
measure: compare the before-after variation in the daily number of steps
timeFrame: 18 weeks
measure: compare the before-after variation in heart rate
timeFrame: 18 weeks
measure: compare the frequency and intensity of vesico-sphincter disorders
timeFrame: 18 weeks
measure: compare the anorectal disorders
timeFrame: 18 weeks
measure: compare the quality of life
timeFrame: 18 weeks
measure: compare the fatigue
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM, Hôpital Pitié-Salpêtrière
Study officials:
References: