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

Hereditary Spastic Paraparesis Clinical Trial

— WALK-up  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229626
• Other study ID #: APHP230987
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Pauline Lallemant, MD
• Phone: 1. 57.27.46.69
• Email: pauline.lallemant[@]icm-institute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 4 months of protocol inclusion

• Discontinuation of private physiotherapy,

• Refusal to participate in the protocol,

• Participation in another interventional research study, or being in the exclusion period following a previous study, if applicable.

• Pregnant women

• Not affiliated to a social security scheme or beneficiary of such a scheme

• Patient under guardianship or trusteeship

Related Conditions & MeSH terms

• Hereditary Spastic Paraparesis
• Muscle Spasticity
• Paraparesis
• Paraparesis, Spastic

Intervention

Other:
• intensive 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

Country	Name	City	State
France	ICM, Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	18 weeks
Secondary	compare the clinical evolution of spasticity	clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)	18 weeks
Secondary	compare the lower-limb joint amplitudes	clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale	18 weeks
Secondary	compare the patients' mood evolution	patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale	18 weeks
Secondary	compare the evolution of cognitive disorders	evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)	18 weeks
Secondary	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
Secondary	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
Secondary	compare the frequency and intensity of vesico-sphincter disorders	compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore	18 weeks
Secondary	compare the anorectal disorders	compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile	18 weeks
Secondary	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
Secondary	compare the fatigue	compare the fatigue using the Modified Fatigue Impact Scale (MFIS)	18 weeks