ICM, Hôpital Pitié-Salpêtrière
Paris, 75013, France
Location status: Recruiting
Location contact
Pauline Lallemant, MD
CONTACT
1. 57.27.46.69 ext. +33
Pauline Lallemant, MD
CONTACT
Rania Hilab, CRA
CONTACT
1. 57.27.46.91 ext. +33
NCT Number: NCT06229626
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
Pauline Lallemant, MD
CONTACT
1. 57.27.46.69 ext. +33
Pauline Lallemant, MD
CONTACT
Rania Hilab, CRA
CONTACT
1. 57.27.46.91 ext. +33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 18 weeks
clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)
Time frame: 18 weeks
clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale
Time frame: 18 weeks
patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale
Time frame: 18 weeks
evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)
Time frame: 18 weeks
before-after variation in the number of steps taken daily under ecological conditions, reported by pedometer
Time frame: 18 weeks
before-after variation in heart rate during walking assessments (6-minute and 10-meter tests)
Time frame: 18 weeks
compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore
Time frame: 18 weeks
compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile
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.
Time frame: 18 weeks
compare the fatigue using the Modified Fatigue Impact Scale (MFIS)
Contact information is provided by the study sponsor or research team.
Pauline Lallemant, MD
CONTACT
1. 57.27.46.69 ext. +33
Rania Hilab, CRA
CONTACT
1. 57.27.46.91 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Acronym: WALK-up
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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