Identification of Modifying Factors in Hereditary Spastic Paraplegia

NCT ID: NCT05373082

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-04

Study Completion Date

2023-10-03

Brief Summary

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A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving spasticity as well as to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders. A new questionnaire was therefore created to collect additional information to optimize the care of patients with HSP.

Detailed Description

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The only common symptom of hereditary spastic paraplegia (HSP) is the presence of spasticity in the lower limbs, associated with a great clinical and genetic heterogeneity.

A first MODIFSPA study carried out by the team identified environmental factors influencing spasticity: stress, fatigue, physical activity. In this first study, only spasticity was studied but several symptoms appeared to require medical management according to the patients: fatigue and vesico-sphincter disorders.

Following this first study, MODIFSPA2 aims to deepen our knowledge of HSP, via the expertise of patients, to propose a care in adequacy with their needs/demands.

Validated scales are included in the questionnaire to evaluate the frequency and intensity of the symptoms most reported by patients (fatigue, pain and mood disorders). Questions are asked to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders.

Conditions

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Hereditary Spastic Paraplegia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hereditary spastic Paraplegia

Patients with hereditary spastic Paraplegia

questionnaire completion

Intervention Type OTHER

Questionnaire to be completed by patients

Interventions

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questionnaire completion

Questionnaire to be completed by patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* French-speaking adult patients aware of their PSH diagnosis coming to the genetic consultation at the Pitié-Salpêtrière Hospital or informed via an association / website of the BRAINTEAM study network
* Affiliated with social security

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut du Cerveau, ICM

Paris, , France

Site Status

Countries

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France

Other Identifiers

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APHP211621

Identifier Type: -

Identifier Source: org_study_id

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