Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06742697

Flexibility, Resistance, Aerobic, Movement Execution Training Program to Improve Walking in Adults with Hereditary Spastic Paraplegia: A Feasibility Trial

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

20

Participants Needed

2

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hereditary Spastic Paraplegia (HSP) is a group of inherited neurological disorders that cause increasing weakness and stiffness in the lower limbs, leading to significant difficulties with balance and walking speed. There is currently no structured rehabilitation program designed to improve walking in adults with HSP. This research aims to evaluate the feasibility and potential benefits of a training program that focuses on flexibility, muscle strength, motor control, balance, and aerobic fitness. Twenty adults diagnosed with HSP will participate in 10 to 16 therapy sessions lasting 60 to 120 minutes each, scheduled once or twice per week based on individual preferences. The training includes four parts: flexibility exercises combined with electrical stimulation to reduce muscle stiffness; resistance and balance training targeting core and lower limb muscles; movement execution training based on motor learning to improve walking patterns and balance; and aerobic exercise using high-intensity interval training to enhance cardiovascular fitness. After completing the sessions, participants will receive written instructions and video tutorials to support ongoing home exercise. Participants will be assessed before the intervention, immediately after, and three months later. Researchers will track recruitment, retention, adherence to the program, safety, and patient satisfaction. They will also measure improvements in walking endurance and speed, muscle strength, joint movement, balance, and overall function. The study lasts about three months, and the results will help understand the feasibility of this rehabilitation approach for adults with HSP.

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

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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

M

Marco Bortolini, BSc

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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Published Research Related To This Trial

High-Intensity Interval Training After Stroke: An Opportunity to Promote Functional Recovery, Cardiovascular Health, and Neuroplasticity.

Jennifer Crozier, Marc Roig, Janice J Eng...

https://pubmed.ncbi.nlm.nih.gov/29676956

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.

Leonardo Boccuni, Marco Bortolini, Cristina Stefan...

https://pubmed.ncbi.nlm.nih.gov/40040914