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NCT Number: NCT06229626

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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

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.

    Time frame: 6 weeks

    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

Secondary outcomes

  1. compare the before-after variation in distance covered in 6 minutes

    Time frame: 18 weeks

    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

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

    Time frame: 18 weeks

    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

  3. compare the clinical evolution of spasticity

    Time frame: 18 weeks

    clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)

  4. compare the lower-limb joint amplitudes

    Time frame: 18 weeks

    clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale

  5. compare the patients' mood evolution

    Time frame: 18 weeks

    patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale

  6. compare the evolution of cognitive disorders

    Time frame: 18 weeks

    evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)

  7. compare the before-after variation in the daily number of steps

    Time frame: 18 weeks

    before-after variation in the number of steps taken daily under ecological conditions, reported by pedometer

  8. compare the before-after variation in heart rate

    Time frame: 18 weeks

    before-after variation in heart rate during walking assessments (6-minute and 10-meter tests)

  9. compare the frequency and intensity of vesico-sphincter disorders

    Time frame: 18 weeks

    compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore

  10. compare the anorectal disorders

    Time frame: 18 weeks

    compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile

  11. compare the quality of life

    Time frame: 18 weeks

    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.

  12. compare the fatigue

    Time frame: 18 weeks

    compare the fatigue using the Modified Fatigue Impact Scale (MFIS)

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline Lallemant, MD

CONTACT

[email protected]

1. 57.27.46.69 ext. +33

Rania Hilab, CRA

CONTACT

[email protected]

1. 57.27.46.91 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: WALK-up

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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