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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the reeducation group | Experimental | The population included in the reeducation group will benefit, in addition to their usual physiotherapy care (at least 1 session per week), from :
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 :
And will be performed in standing, sitting and lying positions. |
|
| The control group | No Intervention | usual physiotherapy care (at least 1 session per week) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive reeducation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 weeks |
| compare the before-after variation in walking speed over a 10-meters test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pauline Lallemant, MD | Contact | 1. 57.27.46.69 | +33 | pauline.lallemant@icm-institute.org |
| Rania Hilab, CRA | Contact | 1. 57.27.46.91 | +33 | rania.hilab@icm-institute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICM, Hôpital Pitié-Salpêtrière | Recruiting | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D015419 | Spastic Paraplegia, Hereditary |
| ID | Term |
|---|---|
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
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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 |
| 18 weeks |
| compare the clinical evolution of spasticity | clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS) | 18 weeks |
| compare the lower-limb joint amplitudes | clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale | 18 weeks |
| compare the patients' mood evolution | patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale | 18 weeks |
| compare the evolution of cognitive disorders | evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS) | 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 | 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) | 18 weeks |
| compare the frequency and intensity of vesico-sphincter disorders | compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore | 18 weeks |
| compare the anorectal disorders | compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile | 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. | 18 weeks |
| compare the fatigue | compare the fatigue using the Modified Fatigue Impact Scale (MFIS) | 18 weeks |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |