Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast (WALK-up)

November 21, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: the reeducation group

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
  • 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
No Intervention: The control group
usual physiotherapy care (at least 1 session per week)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 weeks
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
18 weeks
compare the clinical evolution of spasticity
Time Frame: 18 weeks
clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)
18 weeks
compare the lower-limb joint amplitudes
Time Frame: 18 weeks
clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale
18 weeks
compare the patients' mood evolution
Time Frame: 18 weeks
patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale
18 weeks
compare the evolution of cognitive disorders
Time Frame: 18 weeks
evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)
18 weeks
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
18 weeks
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)
18 weeks
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
18 weeks
compare the anorectal disorders
Time Frame: 18 weeks
compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile
18 weeks
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.
18 weeks
compare the fatigue
Time Frame: 18 weeks
compare the fatigue using the Modified Fatigue Impact Scale (MFIS)
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP230987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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