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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07058870
• Lead Sponsor: University Hospital of Ferrara

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2025-03
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Balance	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)	The change in balance will be assessed using the Fullerton Advanced Balance Scale

Secondary Outcome Measures

Name	Time	Method
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)	Mobility, balance, walking ability, and fall risk will be assessed through Timed Up and Go Test
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)	Dual Task Cost will be assessed by the difference between Timed Up and Go and Dual Task Timed Up and Go
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)	Leg function performance and quantitative mobility assessed through Timed 25 Foot Walk
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)	Paced Auditory Serial Addition Test will be used to assess auditory information processing speed and flexibility
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)	10 Meters Walking Test will be used to assess the change in walking speed
Change in ability to modify balance while walking in the presence of external demands	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)	The extended version of the Dynamic Gait Index will be used to assess ability to modify balance while walking in the presence of external demands
Change in dynamic balance during an activity requiring weight-shift and movement while in single-leg stance	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)	Step Test will be used to assess the change in dynamic balance during an activity requiring weight-shift and movement while in single-leg stance
Change in ability to transition from a supine positon to a standing position.	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)	The Supine To Stand Test will be used to assess the ability to transition from a supine positon to a standing position.
Change in functional lower extremity strength	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)	Five Times Sit to Stand will be used to assess functional lower extremity strength
Change in Walking capacity	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)	Walking capacity will be assessed through the 6 Minute Walking Test
Change in Subjective Trait Fatigue	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 subjective trait fatigue will be assessed through Modified Fatigue Impact Scale
Change in impacts of multiple sclerosis in people' lifes	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)	The impact of multiple sclerosis in people' lifes will be assessed through Multiple Sclerosis Impact Scale 29.
Change in balance confidence	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 balance confidence will be assessed through Activity-Specific Balance Confidence Scale.
Change in perceieved impact of MS on the individual's walking ability.	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)	The 12-item Multiple Sclerosis Walking Scale (MSWS-12) will be used to measure of the impact of MS on the individual's walking ability.
Change in Walking Fatigability	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)	The Distance Walking Index will be used to assess the Change in Walking Fatigability

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, FE, Italy