Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intensive reeducation.
- Who it may be relevant to
- Registry conditions: Hereditary Spastic Paraparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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
Primary outcome measures
- to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group. [Time frame: 6 weeks]
Secondary outcome measures (12)
- compare the before-after variation in distance covered in 6 minutes [Time frame: 18 weeks]
- compare the before-after variation in walking speed over a 10-meters test [Time frame: 18 weeks]
- compare the clinical evolution of spasticity [Time frame: 18 weeks]
- compare the lower-limb joint amplitudes [Time frame: 18 weeks]
- compare the patients' mood evolution [Time frame: 18 weeks]
- compare the evolution of cognitive disorders [Time frame: 18 weeks]
- compare the before-after variation in the daily number of steps [Time frame: 18 weeks]
- compare the before-after variation in heart rate [Time frame: 18 weeks]
- compare the frequency and intensity of vesico-sphincter disorders [Time frame: 18 weeks]
- compare the anorectal disorders [Time frame: 18 weeks]
- compare the quality of life [Time frame: 18 weeks]
- compare the fatigue [Time frame: 18 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- ICM, Hôpital Pitié-Salpêtrière — Paris
Identifiers
NCT: NCT06229626 · APHP230987