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

Assistance Publique - Hôpitaux de Paris50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hereditary Spastic Paraparesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.

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

Time frame: 6 weeks

Secondary Outcomes

compare the before-after variation in distance covered in 6 minutes

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

Time frame: 18 weeks

compare the before-after variation in walking speed over a 10-meters test

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

Time frame: 18 weeks

compare the clinical evolution of spasticity

clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)

Time frame: 18 weeks

compare the lower-limb joint amplitudes

clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale

Time frame: 18 weeks

compare the patients' mood evolution

patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale

Time frame: 18 weeks

compare the evolution of cognitive disorders

evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)

Time frame: 18 weeks

compare the before-after variation in the daily number of steps

before-after variation in the number of steps taken daily under ecological conditions, reported by pedometer

Time frame: 18 weeks

compare the before-after variation in heart rate

before-after variation in heart rate during walking assessments (6-minute and 10-meter tests)

Time frame: 18 weeks

compare the frequency and intensity of vesico-sphincter disorders

compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore

Time frame: 18 weeks

compare the anorectal disorders

compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile

Time frame: 18 weeks

compare the quality of life

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.

Time frame: 18 weeks

compare the fatigue

compare the fatigue using the Modified Fatigue Impact Scale (MFIS)

Time frame: 18 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts