Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate Gait Impairment: A Feasibility Study

NCT ID: NCT07058870

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-02-28

Brief Summary

The goal of this feasibility study is to test the safety and effectiveness of an high-intensity task oriented circuit training program, followed by three months of telerehabilitation in people with mild to moderate Multiple Sclerosis (MS). The main questions it aims to answer are:

• Can high-intensity task oriented circuit training improve gait and balance functional capacity?
• Can telerehabilitation mantain the benefits in gait and balance gained via circuit training for a six month period?

Participants will:

• Complete 10 session ( one hour each, three times a week) of high-intensity task oriented circuit training administered in a hospital setting. The training will target key motor skills such as walking, stepping, supine to stand transitions and general mobility.
• Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision)

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: High Intensity Task Oriented Circuit Training + Telerehabilitation

Participants will receive 10 sessions (one hour each, three times a week) including structured exercise stations targeting key motor skills such as walking, walking adaptability, stepping and supine to stand transition.

Afterwards, participants will engage in 36 sessions (30 minutes each, three times a week) of asynchronous telerehabilitation targeting supine to stand transition, stepping and walking.

Group Type: EXPERIMENTAL

High Intensity Task Oriented Circuit Training + Telerehabilitation

Intervention Type: BEHAVIORAL

Participants will receive 10 sessions of high-intensity, task-oriented circuit training, three times a week. Each session will last 60 minutes, with minutes of active training. Each session will include three rounds, each lasting 55 minutes. During each round, participants will rotate between stations working for four minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including supine to stand transitions, walking speed and functional capacity, walking adaptability and stepping. After in-hospital treatment participants will receive 36 sessions of asynchronous telerehabilitation, three times a week for 12 weeks. This intervention will be supported by low-cost, off-the-shelf technology for treatment delivery and monitoring.

Interventions

High Intensity Task Oriented Circuit Training + Telerehabilitation

Participants will receive 10 sessions of high-intensity, task-oriented circuit training, three times a week. Each session will last 60 minutes, with minutes of active training. Each session will include three rounds, each lasting 55 minutes. During each round, participants will rotate between stations working for four minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including supine to stand transitions, walking speed and functional capacity, walking adaptability and stepping. After in-hospital treatment participants will receive 36 sessions of asynchronous telerehabilitation, three times a week for 12 weeks. This intervention will be supported by low-cost, off-the-shelf technology for treatment delivery and monitoring.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary or secondary progressive multiple sclerosis according to the McDonald criteria.
• Mini-Mental State Examination (MMSE) score > 24.
• Expanded Disability Status Scale (EDSS) score ≤ 6.

Exclusion Criteria

• Presence of other psychiatric or neurological disorders.
• Cardiopulmonary, renal, or liver diseases.
• Pregnancy.
• Modifications in drug treatment within the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ferrara University Hospital

Ferrara, FE, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sofia Straudi, MD, PhD

Role: CONTACT

sofia.straudi@unife.it

+390532238720

Facility Contacts

Sofia Straudi, MD, PhD

Role: primary

sofia.straudi@unife.it

0532238720

Other Identifiers

UNLOCK_MS_MGI_HITOCT

Identifier Type: -

Identifier Source: org_study_id