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NCT Number: NCT07058870

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

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)

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ferrara University Hospital

Ferrara, FE, 44 124, Italy

Location status: Recruiting

Location contact

Andrea Baroni, PT, PhD

SUB_INVESTIGATOR

Gabriele Perachiotti, PT, PhD student

SUB_INVESTIGATOR

Sofia Straudi, MD, PhD

CONTACT

[email protected]

0532238720

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Balance

    Time frame: 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 outcomes

  1. Change in mobility, balance, walking ability, and fall risk

    Time frame: 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

  2. Change in Dual task Cost

    Time frame: 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

  3. Change in quantitative mobility and leg function performance

    Time frame: 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

  4. Change in auditory information processing speed and flexibility

    Time frame: 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

  5. Change in Walking Speed

    Time frame: 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

  6. Change in ability to modify balance while walking in the presence of external demands

    Time frame: 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

  7. Change in dynamic balance during an activity requiring weight-shift and movement while in single-leg stance

    Time frame: 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

  8. Change in ability to transition from a supine positon to a standing position.

    Time frame: 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.

  9. Change in functional lower extremity strength

    Time frame: 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

  10. Change in Walking capacity

    Time frame: 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

  11. Change in Subjective Trait Fatigue

    Time frame: 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

  12. Change in impacts of multiple sclerosis in people' lifes

    Time frame: 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.

  13. Change in balance confidence

    Time frame: 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.

  14. Change in perceieved impact of MS on the individual's walking ability.

    Time frame: 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.

  15. Change in Walking Fatigability

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Straudi, MD, PhD

CONTACT

[email protected]

+390532238720

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study

Acronym: UNLOCK MS MGI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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