NCT06728787 Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)
| NCT ID | NCT06728787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2012-01-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Patients will undergo a combined rehabilitation treatment consisting of 15 sessions on Lokomat and 15 sessions of physical therapy over three weeks for a total of 30 sessions. Two sessions/day for 5 days a week. The same subjects will conduct clinical-functional assessments before, at the end of treatment, and after a 3-month follow-up: 3D Gait Analysis with defined protocol (BTSBioenginner); Spastic Paraplegia Rating Scale (SPRS); Six-Minute Walk Test (6MWT), Ten Meters Walk Test (10MWT), Gross Motor Function Measure-88 (GMFM-88) and Berg Balance Scale (BBS); Quality of life questionnaires: Medical Outcome Survey Short Form (SF-36) and ad hoc questionnaire for subjective assessment of symptoms during walking (HSP-SNAP). This study is part of normal clinical practice and does not involve any changes to the current rehabilitation course for patients.
Eligibility Criteria
Inclusion Criteria: * genetic or clinical diagnosis of HSP. * age greater than 4 years and less than 70 * femur length \> 23 cm * ability to walk independently indoors, with or without walking aids. Exclusion Criteria: * botulinum toxin injection or lower limb surgery in the previous 6 months * severe lower limb muscle retractions * severe osteoporosis * unhealed skin lesions in lower limbs * cardiovascular instability * acute or progressive neurological disorders * behavioral problemS