Clinical Trial

Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia

Study acronym: FRAME
Recruiting
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Summary
Hereditary Spastic Paraplegia (HSP) is a diverse group of genetic neurological conditions causing progressive weakness and spasticity in the lower limbs, severely reducing balance and gait capabilities. There is currently a lack of structured neurorehabilitation programs aimed at improving gait in adults with HSP. This protocol seeks to assess the feasibility and effectiveness of a structured training approach focusing on flexibility, muscle strength, motor control, balance, and aerobic capacity. To this end, twenty adults diagnosed with HSP will engage in 10 to 16 sessions, each lasting 60 to 120 minutes, guided by a therapist once or twice a week, depending on individual preferences. At the end of the program, participants will receive a transfer package, including written instructions (a manual) and video tutorials, to encourage ongoing exercise at home. Assessments will occur before the intervention (T0), immediately after (T1), and three months later (T2). The primary outcomes will measure the feasibility of the program, including recruitment, retention, adherence, the absence of adverse events, and patient satisfaction. Secondary outcomes will focus on improvements in gait capabilities such as gait endurance and gait speed.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-18.
Status change: Not Yet Recruiting → Recruiting 2025-01-28
Trial Details
NCT Number NCT06742697
Lead Sponsor IRCCS Eugenio Medea
Conditions Hereditary Spastic Paraplegia
Enrollment 20 participants
Start Date 2024-12-23
Primary Completion 2026-12 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-01-30