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RECRUITING
NCT06742697
NA

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

Sponsor: IRCCS Eugenio Medea

View on ClinicalTrials.gov

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.

Official title: Flexibility, Resistance, Aerobic, Movement Execution (FRAME) Training Program to Improve Gait Capacity in Adults With Hereditary Spastic Paraplegia: Protocol for a Single-cohort Feasibility Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-12-23

Completion Date

2027-04

Last Updated

2025-01-30

Healthy Volunteers

No

Interventions

BEHAVIORAL

Flexibility, Resistance, Aerobic, Movement Execution training

Flexibility: static and dynamic stretching combined with sensory, high-frequency electrical stimulation to reduce spasticity and improve mobility. Resistance training: core stability and lower limb strength training in conditions of instability, to improve strength, coordination, and balance. Movement execution training: gait training according to motor learning principles. Aerobic exercise: in the form of high-intensity interval training at the end of each session, to improve cardiovascular status and foster motor learning consolidation (probably due to the release of brain derived neurothrophic factors).

Locations (2)

Scientific Institute, IRCCS E. Medea, Department of Bosisio Parini, Lecco, Italy.

Bosisio Parini, Lombardy, Italy

Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy

Pieve di Soligo, Veneto, Italy