RecruitingNot ApplicableNCT06229626

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

50 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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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


Locations(1)

ICM, Hôpital Pitié-Salpêtrière

Paris, France

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NCT06229626


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