Task-oriented Training Intervention for Multiple Sclerosis Patients.

Task-oriented Training Intervention for Multiple Sclerosis Patients

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Task-oriented training; Other: Standar medical care and leaflet fatigue management

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Faculty of Health Sciences. University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Task-oriented training program	Other: Task-oriented training; 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.
Active Comparator: Standard medical care and leaflet fatigue management	Other: Standar medical care and leaflet fatigue management; Participants included in the control group will continue with their usual treatment and will receive a pamphlet containing information on fatigue management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	The level of fatigue will be assessed with the Modified Impact Fatigue Scale (MFIS) and the Fatigue Severity Scale (FSS). The MFIS consists of items from which a total score is obtained and for each subscale. Scores range from 0 to 36 with higher scores indicating a greater impact of fatigue on activities. The FSS consists of 9 items that are rated on a scale of 1 to 7. A higher score indicates a higher agreement with the statement presented in each item.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb strengh	Upper limb strength will be assessed using the Arm Curl Test (ACT). The ACT consists of performing as many arm curls as possible in 30 seconds while seated in a chair.	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	Upper limb strength will be assessed using a hand and pinch dynamometer. The dynamometer and hand dynamometer measure grip and pinch strength respectively.	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	Motor speed will be assessed with the Finger Tapping Test (FTT). In this test, the number of finger taps the participant is able to perform in three attempts of 20 seconds each is counted.	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)
Manual dexterity - 9HPT	Manual dexterity will be assessed using the Nine Hole Peg Test (9HPT). 9HPT requires the participant to place and then remove nine pegs, one at a time, into nine holes on a board as quickly as possible. The test is performed separately with each hand, and the time taken to complete the task is recorded. Shorter completion times indicate better manual dexterity.	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)
Manual dexterity - Purdue	Manual dexterity will be assessed using the Purdue Pegboard Test. Purdue Pegboard Test involves placing as many pins as possible into holes on a board. It includes subtests for dominant and non-dominant hand, both hands simultaneously, and an assembly task. Higher scores reflect better dexterity.	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)
Manual dexterity - CRT	Manual dexterity will be assessed using the Coin Rotation Test (CRT). CRT assesses the coordination and speed of the fingers by rotating a coin clockwise with three fingers of the hand (thumb, index and middle finger) as fast as possible.	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)
Satisfaction and adherence with the intervention	Satisfaction and adherence with the intervention will be recorded with the Sport Injury Rehabilitation Adherence Scale (SIRAS). Although originally designed for sport settings, it has been used to assess adherence and satisfaction in chronic populations.	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)

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 036-N-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No