Task-oriented Training Intervention for Multiple Sclerosis Patients.

N/AEnrolling By InvitationNCT07106255

Universidad de Granada58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Task-oriented trainingOTHER

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.

Standar medical care and leaflet fatigue managementOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Health Sciences. University of Granada

Granada, Granada, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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

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.

Time frame: 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)

Data from ClinicalTrials.gov

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