Training program for adults with hereditary spastic paraplegia
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
This study is testing a training program to see if it can help adults with hereditary spastic paraplegia improve their strength, balance, and walking ability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 2 sites (Bosisio Parini, Lombardy and 1 other locations) |
| Trial ID | NCT06742697 on ClinicalTrials.gov |
What this trial studies
This study evaluates a structured training program designed to improve flexibility, muscle strength, motor control, balance, and aerobic capacity in adults diagnosed with hereditary spastic paraplegia (HSP). Participants will engage in 10 to 16 sessions, each lasting 60 to 120 minutes, guided by a therapist. The program aims to assess both the feasibility of recruitment and adherence, as well as the therapeutic efficacy in enhancing walking endurance and speed. Assessments will be conducted before, immediately after, and three months post-intervention to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with hereditary spastic paraplegia who can walk independently and have functional deficits affecting their mobility.
Not a fit: Patients who have undergone recent botulinum toxin treatment or surgery for lower limb hypertonia may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve walking abilities and overall quality of life for patients with hereditary spastic paraplegia.
How similar studies have performed: While there have been specific interventions for HSP, this comprehensive training approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults diagnosed with Hereditary Spastic Paraplegia. * Presence of any functional deficit in the lower limbs that affects walking, such as muscle weakness, hypertonia, or balance issues. * Ability to walk without the need for physical contact with another person, as defined by a Functional Ambulation Category score of 3 or higher. * Ability to understand simple instructions, comprehend the purpose of the study, willingness to participate and undergo at least 10 treatment sessions, eligible and willing to sign the informed consent. Exclusion Criteria: * Botulinum toxin or surgery to treat lower limb hypertonia in the six months prior to enrollment in the study. * Contraindications for moderate physical activity, such as stretching exercises, muscle strength training, and aerobic capacity training.
Where this trial is running
Bosisio Parini, Lombardy and 1 other locations
- Scientific Institute, IRCCS E. Medea, Department of Bosisio Parini, Lecco, Italy. — Bosisio Parini, Lombardy, Italy (Recruiting)
- Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy — Pieve di Soligo, Veneto, Italy (Recruiting)
Study contacts
- Principal investigator: Leonardo Boccuni, PhD — Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.
- Study coordinator: Leonardo Boccuni, PhD
- Email: leonardo.boccuni@lanostrafamiglia.it
- Phone: 003904384141
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.