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Clinical Trials in Italy / NCT06728787
Recruiting Observational

Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)

NCT06728787 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2012-01-01
Last updated
2025-05-04

Condition(s) studied

Hereditary Spastic Paraplegia

Investigational drug(s) / intervention(s)

Robot-Assisted Gait Training

Robot-Assisted Gait Training: 15 sessions of robot-assisted gait training(LOKOMAT)+ 15 session of usual treatment for a total of 30 sessions in three weeks. 45 minutes for each session.

Study 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

Sex
ALL
Min age
4 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Irccs Eugenio Medea Bosisio Parini Italy/lecco Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728787 on ClinicalTrials.gov ↗ ← All trials in Italy