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

NCT ID: NCT07058896

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Intensity Task Oriented Circuit Training + Telerehabilitation

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.

Group Type: EXPERIMENTAL

High intensity task oriented circuit training + Telerehabilitation

Intervention Type: 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.

Interventions

High intensity task oriented circuit training + Telerehabilitation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ferrara University Hospital

Ferrara, FE, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sofia Straudi, MD, PhD

Role: CONTACT

sofia.straudi@unife.it

+390532238720

Facility Contacts

Sofia Straudi, MD, PhD

Role: primary

sofia.straudi@unife.it

0532238720

Other Identifiers

UNLOCK_MS_SGI_HITOCT

Identifier Type: -

Identifier Source: org_study_id