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NCT Number: NCT07058896

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

Multiple sclerosis (MS) is a progressive neurological disorder that often leads to severe gait impairment, limiting mobility and reducing the patient's quality of life. Motor rehabilitation has shown positive effects in people with MS (PwMS), but its efficacy tends to decrease as disability severity increases. High-intensity, task-oriented circuit training based on the principles of motor learning has been proposed as a potential strategy to improve motor function in severely impaired individuals.

This approach combines the benefits of high-intensity training to the motor learning principles to enhance motor skills improvement and retention.

The main questions it aims to answer are:

* Can high-intensity, task oriented training in PwMS with severe gait impairment be feasible, safe and effective in enhancing motor function? * Can telerehabilitation maintain the benefits in gait and balance gained via circuit training for a six month period?

Participants will:

* Complete 12 session ( three 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, sit to stand, wheelchair, standing and bed mobillity. * Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision), including monthly televisits.

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Key information

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 ≥ 6.5.

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 12 sessions of high-intensity, task-oriented circuit training, three times a week for four weeks. Each session will last 180 minutes, with 108 minutes of active training. Each session will include three rounds, each lasting 51 minutes. During each round, participants will rotate between stations working for six minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including sit-to-stand transitions, walking, standing, bed mobility and transfers, stepping, and wheelchair use. If participants are unable to walk, the walking station will be replaced by upper limb function station.

After in-hospital treatment participants will receive 36 sessions of asynchronous telerehabilitation, three times a week for 12 weeks. Including monthly televisits with the physiotherapist. This intervention will be supported by low-cost, off-the-shelf technology for treatment delivery and monitoring.

Primary outcomes

  1. Change in Static 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 static balance will be assessed using the Berg Balance Scale

Secondary outcomes

  1. 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

  2. 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)

    Walking speed will be assesed through the Timed 25 Foot Walk

  3. 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

  4. 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

  5. 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

  6. Changes 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

  7. Change in cardiovascular fitness

    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)

    Cardiovascular fitness will be assessed with 6 Minute Push Test

  8. 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

  9. 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.

  10. 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.

  11. Change in functional performance of the upper extremity

    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)

    Functional performance of the upper extremity will assessed through Action Research Arm Test

  12. Change in self perceived manual 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)

    Self perceived manual ability will be assessed through ABILHAND 26

  13. 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 Severe Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study

Acronym: UNLOCK MS SGI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
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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