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Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

NCT ID: NCT01303770

Last Updated: 2013-12-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

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Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.

Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.

The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.

Detailed Description

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Conditions

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Multiple Sclerosis Cognitive Impairment

Keywords

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Multiple Sclerosis Cognitive impairment Self-management programs Occupational Therapy Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive intervention group

Cognitive rehabilitation program designed to be tested in this study

Group Type EXPERIMENTAL

Self-management cognitive rehabilitation group intervention

Intervention Type BEHAVIORAL

8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.

Control group

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type BEHAVIORAL

8-week group program that is not specifically directed to management of cognitive impairments.

Interventions

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Self-management cognitive rehabilitation group intervention

8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.

Intervention Type BEHAVIORAL

Control intervention

8-week group program that is not specifically directed to management of cognitive impairments.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MS
* 18 years of age or older
* Self-report of cognitive difficulties

Exclusion Criteria

* Exacerbation of symptoms in past 3 months
* History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Eynat Shevil

Dr. Eynat Shevil

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eynat Shevil, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

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Rabin Medical Center, Multiple Sclerosis Clinic

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PIRG03-GA-2008-230959

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MSCogRehab

Identifier Type: -

Identifier Source: org_study_id