ClinicalTrials.gov record NCT06229626

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study is for adults with genetically confirmed SPG4 (SPAST) hereditary spastic paraparesis. It compares a 6-week intensive physical rehabilitation program added to usual physiotherapy versus usual physiotherapy alone. The primary measurement is change in distance on a 6-minute walk test at 6 weeks, with additional outcomes followed to 18 weeks.

What it is studying. The study evaluates the effect of adding a structured, intensive 6-week physiotherapy program to patients' usual care on walking ability in SPG4 hereditary spastic paraparesis. The intervention adds three 30-minute sessions per week (one supervised group session or videoconference plus two home sessions with video support) to usual physiotherapy. The study measures walking distance/speed and a range of clinical outcomes.

What the researchers hope to learn. Scientific goals: to measure whether a 6-week intensive rehabilitation program changes 6-minute walk distance in SPG4 HSP and to compare effects on 10-meter walking speed, spasticity (SPRS, modified Ashworth), joint range, daily steps, heart rate during walking, mood (HAD), cognition (CCAS), bladder/bowel symptoms, quality of life (EQ-5D), and fatigue (MFIS).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • intensive reeducation

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized to either a 6-week intensive reeducation program in addition to their usual physiotherapy or to continue usual physiotherapy (at least one session/week). The intensive program adds three 30-minute sessions per week for 6 weeks: one group session (in-person or by videoconference) plus two home sessions guided by emailed video materials; exercises include stretching, posture work, muscle strengthening and proprioception performed standing, sitting and lying. Assessments include a 6-minute walk test at baseline and 6 weeks (primary outcome) and additional tests and questionnaires at baseline and 18 weeks (10‑meter walk, spasticity and joint scales, mood and cognition scales, daily steps by pedometer, heart rate during walking, bladder/bowel questionnaires, quality of life and fatigue). No invasive procedures are described in the record.

How the study is structured. Interventional, randomized, open-label study with two parallel groups. All participants continue at least one weekly physiotherapy session; the experimental group receives three extra 30-minute sessions per week for 6 weeks (group/videoconference plus home video sessions). Assessments include a 6-minute walk at baseline and 6 weeks (primary outcome) and additional follow-up measures up to 18 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Hereditary Spastic Paraparesis. Does it apply to my diagnosis?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hereditary spastic paraplegia

Clinical trials21 trials listed for hereditary spastic paraplegiaEvery trial the registry lists for hereditary spastic paraplegia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hereditary spastic paraplegia researchLatest monthly update: September 2026. Includes: SPTSSA treatment signal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 4, 2024
Primary completion
October 2026 (estimated)
Study completion
October 2026 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Nov 25, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
parallel groups
Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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