Task-oriented Training Intervention for Multiple Sclerosis Patients.

NCT07106255 | Enrolling By Invitation

• 1 other identifier: 036-N-23
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a Task-oriented program in improving functional performance and health outcomes in patients with Multiple Sclerosis.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Occupational Performance

  The main variable in this study will be the Canadian Occupational Performance Measure (COPM). This tool measures the perception of problems related to the overall quality of performance, development and satisfaction with particular occupations.

  Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)

Secondary Outcomes (1)

• Fatigue

  Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)

Other Outcomes (7)

• Upper limb strengh

  Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)

• Upper limb strengh 2

  Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)

• Motor speed

  Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)

Study Arms (2)

Task-oriented training program

EXPERIMENTAL

Task-oriented training program

Other: Task-oriented training

Standard medical care and leaflet fatigue management

ACTIVE COMPARATOR

Other: Standar medical care and leaflet fatigue management

Interventions

Task-oriented training OTHER

Participants included in the experimental group will underwent an 8-week TOT intervention, administered twice weekly, with each session lasting 45 minutes. Within this framework, the intervention will comprise sessions involving meaningful and repetitive activities tailored to both the patient and their specific context. The occupations will be selected by each participant through the Canadian Occupational Performance Measure (COMP) tool in the initial assessment. The activities were randomly ordered and focused on the reconstruction of complete tasks. To support task segmentation, a range of custom-designed materials will be employed, alongside therapeutic tools and materials such as therapeutic putty, TheraBand, and others commonly used in physical rehabilitation interventions. Throughout the intervention, participants will receive positive reinforcement that will fade over the time to prevent unnecessary dependency.

Task-oriented training program

Standar medical care and leaflet fatigue management OTHER

Participants included in the control group will continue with their usual treatment and will receive a pamphlet containing information on fatigue management.

Standard medical care and leaflet fatigue management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Multiple Sclerosis by a neurologist.
• Aged over 18 years old.
• Acceptance and signature of the informed consent.

You may not qualify if:

• A cognitive level or condition that did not allow completion of the evaluations.
• An exacerbation of MS during the previous 3 months.
• Presence of interfering musculoskeletal, neurological, orthopaedic, and/or rheumatic disorders affecting hand and/or finger mobility, including previous trauma or fracture of the upper extremity.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

ES (1)