Occupational Therapy in Patients With Multiple Sclerosis

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Completed

CT.gov ID

NCT01507636

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. Apraxia and impaired manual dexterity are common problems in patients with MS leading to impaired activities of daily living. However, a specific training program to improve apraxia as well as manual dexterity in MS is lacking.

In this study, the investigators want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.

Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia and manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks.

At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in all patients.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Apraxia	Other: Occupational Therapy Other: Physical therapy	N/A

Detailed Description

Background

Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. It impairs real object/tool use as well as pantomime and imitation of gestures affecting both sides of the body and can be a major source of disability independent of other neurological deficits. It significantly affects activities of daily living (ADL) and is associated with poorer outcome for independent living or return to work.

Apraxia is largely based on left parieto-frontal damage due to focal injury or more widespread neurodegeneration of cortical areas and/or their connections. However, apraxia has been described in damage of the right hemisphere, although less frequent and severe.

Apraxia is increasingly recognized as a clinical problem in restorative neurology and various approaches were described how to treat the disorder.

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. It is characterized by focal demyelination as well as axonal damage. MS has been classically thought of as a typical white matter disorder. However, early pathology studies and recent magnetic resonance tomography (MRI) studies show demyelination in the cortex and deep gray matter nuclei. Grey matter damage starts early in the disease and substantially affects cognitive functioning.

Apraxia and impaired manual dexterity are common problems in MS leading to impaired activities of daily living. However, a specific training program to improve apraxia and manual dexterity in MS is lacking. In this study, we want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.

It is a rater-blind, randomized, controlled trial. Patients routinely seen in our MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia using the AST (Apraxia Screen of TULIA). In case of Apraxia patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks (4 times 5 days in a row).

At study entry and study end after 4 weeks, apraxia will be tested in all patients using the extended version of the AST, the TULIA. Furthermore, a questionnaire on "activities of daily living" and "quality of life" will be evaluated, and test regarding cognition, spasticity, ataxia, fatigue as well as the EDSS will be performed.

Objective

To evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS.

Methods

see above.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Occupational therapy using a special arm function training.	Other: Occupational Therapy Occupational therapy using a special arm function training.
Active Comparator: Group 2 Physical therapy using the Theraband for training of force.	Other: Physical therapy Physical therapy for arm force training.

Arm

Intervention/Treatment

Active Comparator: Group 1

Occupational therapy using a special arm function training.

Other: Occupational Therapy

Occupational therapy using a special arm function training.

Active Comparator: Group 2

Physical therapy using the Theraband for training of force.

Other: Physical therapy

Physical therapy for arm force training.

Outcome Measures

Primary Outcome Measures

Change in apraxia score as measured by TULIA [From day of randomisation to end of study, expected to be after 4 weeks]

Secondary Outcome Measures

Change in manual dexterity [From day of randomisation to end of study, expected to be after 4 weeks]
Measured by the coin rotation task and 9-hole-peg-test
Change in activities of daily living [From day of randomisation to end of study, expected to be after 4 weeks]
Measured by questionnaire
Change in quality of life [From day of randomisation to end of study, expected to be after 4 weeks]
Measured by questionnaire
Change in fatigue [From day of randomisation to end of study, expected to be after 4 weeks]
Measured by questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with all forms of MS
Age 18-60 years

Exclusion Criteria

Any disease other than multiple sclerosis that could possibly explain the patient's signs and symptoms
A relapse which started within 60 days prior to the examination
Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, Coronary heart disease or uncompensated congestive heart failure, medication with glycosides.
A history of drug abuse in the 6 months prior to screening