Skip to main content
OpenTrials
Completed

NCT Number: NCT01507636

Occupational Therapy in Patients With Multiple Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational Therapy

Other

Occupational therapy using a special arm function training.

Physical Therapy

Other

Physical therapy for arm force training.

Primary outcomes

  1. Change in apraxia score as measured by TULIA

    Time frame: From day of randomisation to end of study, expected to be after 4 weeks

Secondary outcomes

  1. Change in manual dexterity

    Time frame: 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

  2. Change in activities of daily living

    Time frame: From day of randomisation to end of study, expected to be after 4 weeks

    Measured by questionnaire

  3. Change in quality of life

    Time frame: From day of randomisation to end of study, expected to be after 4 weeks

    Measured by questionnaire

  4. Change in fatigue

    Time frame: From day of randomisation to end of study, expected to be after 4 weeks

    Measured by questionnaire

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2012
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.