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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Feasibility (recruitment rate). — Enrolment (T0), end of treatment five to ten weeks after T0 (T1).
  Study feasibility in terms of achieving sufficient recruitment rate, defined as the enrollment of 20 patients within 24 months from the start of the study.
• Feasibility (adherence rate). — Enrolment (T0), end of treatment five to ten weeks after T0 (T1).
  Study feasibility in terms of achieving adequate adherence to the treatment plan, defined as completing at least 75% of the scheduled treatment sessions, and in any case a minimum of 10 treatment sessions.
• Feasibility (retention rate). — Enrolment (T0), end of treatment five to ten weeks after T0 (T1).
  Study feasibility in terms of achieving sufficient patient retention, defined as at least 75% of the enrolled patients completing the study with adequate adherence to the treatment.
• Feasibility (safety). — Enrolment (T0), end of treatment five to ten weeks after T0 (T1).
  Study feasibility in terms of absence of any serious adverse event related to patient participation in the study.

Trial sites (2)

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