Robot-assisted walking treatment for hereditary spastic paraplegia
Efficacy of Robot-assisted Walking Treatment on Gait Biomechanics, Functional Outcomes, and Quality of Life in Subjects With Hereditary Spastic Paraplegia (HSP)
This study is testing whether using a robot to help with walking, along with regular physical therapy, can improve movement and quality of life for people with hereditary spastic paraplegia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Italy/lecco) |
| Trial ID | NCT06728787 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of a combined rehabilitation approach using the Lokomat robotic gait training system alongside traditional physical therapy for patients with hereditary spastic paraplegia (HSP). Participants will undergo a total of 30 sessions over three weeks, with assessments conducted before, after treatment, and at a three-month follow-up. The study aims to measure improvements in gait, functional abilities, and quality of life through various clinical-functional assessments. This approach seeks to enhance the rehabilitation experience and outcomes for individuals affected by this rare neurological disorder.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 4 to 70 with a genetic or clinical diagnosis of hereditary spastic paraplegia who can walk independently.
Not a fit: Patients with severe lower limb muscle retractions, recent lower limb surgeries, or acute neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mobility and quality of life for patients with hereditary spastic paraplegia.
How similar studies have performed: Previous studies using robotic gait training in neurological disorders have shown promising results, suggesting potential efficacy for this approach in hereditary spastic paraplegia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bosisio Parini, Italy/lecco
- Irccs Eugenio Medea — Bosisio Parini, Italy/lecco, Italy (Recruiting)
Study contacts
- Study coordinator: Eleonora Diella
- Email: eleonora.diella@lanostrafamiglia.it
- Phone: 3286859456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.