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

NCT06229626 | Recruiting

• 1 other identifier: APHP230987
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Spastic Paraparesis

Keywords

physical rehabilitation program; hereditary spastic paraparesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

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

  18 weeks

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

  18 weeks

• compare the clinical evolution of spasticity

  18 weeks

• compare the lower-limb joint amplitudes

  18 weeks

• compare the patients' mood evolution

  18 weeks

Study Arms (2)

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 : * 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 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 : * Stretching * posture * Muscle strengthening * Proprioception And will be performed in standing, sitting and lying positions.

Other: intensive reeducation

The control group

NO INTERVENTION

usual physiotherapy care (at least 1 session per week)

Interventions

intensive reeducation OTHER

* 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

the reeducation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

ICM, Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Central Study Contacts

Pauline Lallemant, MD

CONTACT

1. 57.27.46.69; pauline.lallemant@icm-institute.org

Rania Hilab, CRA

CONTACT

1. 57.27.46.91; rania.hilab@icm-institute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 29, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)