Hereditary Spastic ParaparesisWALK-upNCT06229626
Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
A study testing intensive reeducation in people with Hereditary Spastic Paraparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Spastic Paraparesis
- What is being tested?
- intensive reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ICM, Hôpital Pitié-Salpêtrière
Paris, 75013
Pauline Lallemant, MD, 1. 57.27.46.69 ext. +33, pauline.lallemant@icm-institute.org
Rania Hilab, CRA, 1. 57.27.46.91 ext. +33, rania.hilab@icm-institute.org
About this study
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.
Read the 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.
- Conditions
- Hereditary Spastic Paraparesis
- Being tested
- intensive reeducation
- Keywords
- physical rehabilitation program, hereditary spastic paraparesis
- Medical subject headings
- Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive reeducationOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: intensive reeducation |
| The control group | No intervention | usual physiotherapy care (at least 1 session per week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (12)
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
Measured: 18 weeks
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
Measured: 18 weeks
compare the clinical evolution of spasticity
clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)
Measured: 18 weeks
compare the lower-limb joint amplitudes
clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale
Measured: 18 weeks
compare the patients' mood evolution
patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale
Measured: 18 weeks
compare the evolution of cognitive disorders
evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)
Measured: 18 weeks
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
Measured: 18 weeks
compare the before-after variation in heart rate
before-after variation in heart rate during walking assessments (6-minute and 10-meter tests)
Measured: 18 weeks
compare the frequency and intensity of vesico-sphincter disorders
compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore
Measured: 18 weeks
compare the anorectal disorders
compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile
Measured: 18 weeks
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.
Measured: 18 weeks
compare the fatigue
compare the fatigue using the Modified Fatigue Impact Scale (MFIS)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start4 Apr 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaparesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229626
- Sponsor's protocol ID
- APHP230987
- Acronym
- WALK-up
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
- ClinicalTrials.gov ID
- NCT06229626
- Acronym / sponsor ID
- WALK-up / APHP230987
- Conditions
- Hereditary Spastic Paraparesis
- Keywords
- physical rehabilitation program, hereditary spastic paraparesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the reeducation group | Experimental | Other: intensive reeducationThe 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. |
| The control group | No intervention | –usual physiotherapy care (at least 1 session per week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | the reeducation group |
Primary outcome
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
12 secondary outcomes
compare the before-after variation in distance covered in 6 minutes
Time frame: 18 weeks
compare the before-after variation in walking speed over a 10-meters test
Time frame: 18 weeks
compare the clinical evolution of spasticity
Time frame: 18 weeks
compare the lower-limb joint amplitudes
Time frame: 18 weeks
compare the patients' mood evolution
Time frame: 18 weeks
compare the evolution of cognitive disorders
Time frame: 18 weeks
compare the before-after variation in the daily number of steps
Time frame: 18 weeks
compare the before-after variation in heart rate
Time frame: 18 weeks
compare the frequency and intensity of vesico-sphincter disorders
Time frame: 18 weeks
compare the anorectal disorders
Time frame: 18 weeks
compare the quality of life
Time frame: 18 weeks
compare the fatigue
Time frame: 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive reeducation in people with Hereditary Spastic Paraparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Lallemant, MD (1. 57.27.46.69 ext. +33, pauline.lallemant@icm-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.