Hereditary Spastic Paraparesis
Conditions
Keywords
physical rehabilitation program, hereditary spastic paraparesis
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.
Interventions
OTHERintensive 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compare the before-after variation in distance covered in 6 minutes | 18 weeks | 6-minute walk test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks |
| compare the before-after variation in walking speed over a 10-meters test | 18 weeks | 10-meters test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks |
| compare the clinical evolution of spasticity | 18 weeks | clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS) |
| compare the lower-limb joint amplitudes | 18 weeks | clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale |
| compare the patients' mood evolution | 18 weeks | patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale |
| compare the evolution of cognitive disorders | 18 weeks | evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS) |
| compare the before-after variation in the daily number of steps | 18 weeks | before-after variation in the number of steps taken daily under ecological conditions, reported by pedometer |
| compare the before-after variation in heart rate | 18 weeks | before-after variation in heart rate during walking assessments (6-minute and 10-meter tests) |
| compare the frequency and intensity of vesico-sphincter disorders | 18 weeks | compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore |
| compare the anorectal disorders | 18 weeks | compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile |
| compare the quality of life | 18 weeks | compare the quality of life using the EQ5D scale. The EQ-5D is a self-administered questionnaire that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. |
| compare the fatigue | 18 weeks | compare the fatigue using the Modified Fatigue Impact Scale (MFIS) |
Countries
France
Contacts
Primary ContactPauline Lallemant, MD
Backup ContactRania Hilab, CRA
Outcome results
None listed