Task-oriented Training Intervention for Multiple Sclerosis Patients.

NCT ID: NCT07106255

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Task-oriented training program

Task-oriented training program

Group Type EXPERIMENTAL

Task-oriented training

Intervention Type 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.

Standard medical care and leaflet fatigue management

Group Type ACTIVE_COMPARATOR

Standar medical care and leaflet fatigue management

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Health Sciences. University of Granada

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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036-N-23

Identifier Type: -

Identifier Source: org_study_id

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