Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06742697

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

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

20

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hereditary Spastic Paraplegia (HSP) is a group of inherited neurological conditions causing progressive weakness and stiffness in the lower limbs, which greatly reduce walking ability and balance. This research aims to evaluate the feasibility and effectiveness of a structured training program designed to improve walking function in adults with HSP by focusing on flexibility, muscle strength, motor control, balance, and aerobic fitness. Participants will take part in 10 to 16 therapy sessions lasting between 60 and 120 minutes each, held once or twice a week according to individual preference. The program includes four key components: flexibility exercises combined with electrical stimulation to reduce muscle tone; resistance training targeting hip and trunk muscles along with balance exercises; motor control-based gait training; and high-intensity interval aerobic training using activities like walking or cycling. After completing the supervised sessions, participants will receive written and video materials to support continued exercise at home. Evaluations will be conducted before the program starts, immediately after it ends (5 to 10 weeks later), and three months after completion. Researchers will assess the feasibility by tracking recruitment, adherence to the sessions, participant retention, safety, and satisfaction. They will also measure changes in walking endurance and speed using standardized walking tests, as well as improvements in muscle strength, balance, and joint mobility.

CONDITIONS

Brief 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
  • Presence of functional deficits in the lower limbs affecting walking, such as muscle weakness, spasticity, or balance problems
  • Ability to walk independently without physical assistance, defined by a Functional Ambulation Category score of 3 or higher
  • Ability to understand simple instructions, willing to participate and commit to at least 10 treatment sessions
  • Eligible and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Botulinum toxin treatment or surgery for lower limb spasticity within six months before enrollment
  • Contraindications to moderate physical activity including stretching, muscle strengthening, and aerobic training

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 5 to 10 weeks

Participants receive a comprehensive neurorehabilitation program consisting of flexibility, resistance, movement execution, and aerobic training to improve gait capacity. The program includes 10 to 16 therapist-guided sessions lasting 60 to 120 minutes each, conducted once or twice weekly based on individual preference and capability.

10 to 16 treatment sessions over 5 to 10 weeks

Follow-up

Duration - 12 weeks

Participants are evaluated 12 weeks after completing the treatment to assess sustained improvements in walking endurance and speed.

1 follow-up visit (in-person)

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