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

NCT07058870 | Recruiting

• 1 other identifier: UNLOCK_MS_MGI_HITOCT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

high intensity training; multiple sclerosis; motor learning; mild to moderate multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Balance

  The change in balance will be assessed using the Fullerton Advanced Balance Scale

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

Secondary Outcomes (15)

• Change in mobility, balance, walking ability, and fall risk

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

• Change in Dual task Cost

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

• Change in quantitative mobility and leg function performance

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

• Change in auditory information processing speed and flexibility

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

• Change in Walking Speed

  Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

Study Arms (1)

Experimental: High Intensity Task Oriented Circuit Training + Telerehabilitation

EXPERIMENTAL

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.

Behavioral: High Intensity Task Oriented Circuit Training + Telerehabilitation

Interventions

High Intensity Task Oriented Circuit Training + Telerehabilitation 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.

Experimental: High Intensity Task Oriented Circuit Training + Telerehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, FE, 44 124, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

+390532238720; sofia.straudi@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: October 15, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-03

Locations

IT (1)