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

NCT07058896 | Recruiting

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

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; high intensity training; motor learning; circuit training; rehabilitation; balance; mobility

Outcome Measures

Primary Outcomes (1)

• Change in Static Balance

  The change in static balance will be assessed using the Berg 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 (13)

• 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)

• 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)

• 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 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)

Study Arms (1)

High Intensity Task Oriented Circuit Training + Telerehabilitation

EXPERIMENTAL

Participants will receive 12 sessions of high-intensity, task-focused circuit training, three times a week for four weeks. Each 180-minute session includes 108 minutes of active training, with three rounds of exercises at different stations. Activities will focus on motor skills like standing, walking, transfers, and wheelchair use. If walking isn't possible, upper limb training will be included instead. After hospital treatment, participants will continue with 36 asynchronous telerehabilitation sessions over 12 weeks, including monthly televisits, using low-cost, commercially available technology.

Behavioral: High intensity task oriented circuit training + Telerehabilitation

Interventions

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.

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 ≥ 6.5.

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 28, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-03

Locations

IT (1)