Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06742697

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

Led by IRCCS Eugenio Medea · Updated on 2025-01-30

20

Participants Needed

2

Research Sites

118 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults diagnosed with Hereditary Spastic Paraplegia
  • Functional deficits in the lower limbs affecting walking, such as muscle weakness, high muscle tone, or balance problems
  • Ability to walk independently without physical assistance (Functional Ambulation Category score 3 or higher)
  • Ability to understand simple instructions, willing to participate, complete at least 10 treatment sessions, and able to sign informed consent
Not Eligible

You will not qualify if you...

  • Received botulinum toxin or surgery for lower limb hypertonia within 6 months before enrollment
  • Medical conditions preventing moderate physical activity like stretching, muscle strengthening, or aerobic exercise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Bosisio Parini, Lombardy, Italy, 23842

Actively Recruiting

2

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

Pieve di Soligo, Veneto, Italy, 31053

Actively Recruiting

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Research Team

L

Leonardo Boccuni, PhD

CONTACT

M

Marco Bortolini, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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