Occupational Therapy in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01507636
First received: January 4, 2012
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention
Multiple Sclerosis
Apraxia
Other: Occupational Therapy
Other: Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Change in apraxia score as measured by TULIA [ Time Frame: From day of randomisation to end of study, expected to be after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in manual dexterity [ Time Frame: From day of randomisation to end of study, expected to be after 4 weeks ] [ Designated as safety issue: No ]
    Measured by the coin rotation task and 9-hole-peg-test

  • Change in activities of daily living [ Time Frame: From day of randomisation to end of study, expected to be after 4 weeks ] [ Designated as safety issue: No ]
    Measured by questionnaire

  • Change in quality of life [ Time Frame: From day of randomisation to end of study, expected to be after 4 weeks ] [ Designated as safety issue: No ]
    Measured by questionnaire

  • Change in fatigue [ Time Frame: From day of randomisation to end of study, expected to be after 4 weeks ] [ Designated as safety issue: No ]
    Measured by questionnaire


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507636

Locations
Switzerland
Department of Neurology, Bern university Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Christian P Kamm, MD Department of Neurology, Inselspital Bern, 3010 Bern, Switzerland
  More Information

Publications:
Responsible Party: Dr. med. Christian Philipp Kamm, Department of neurology, University hopsital Bern, Switzerland
ClinicalTrials.gov Identifier: NCT01507636     History of Changes
Other Study ID Numbers: 042/11
Study First Received: January 4, 2012
Last Updated: May 14, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:
apraxia
occupational therapy
multiple sclerosis
manual dexterity

Additional relevant MeSH terms:
Apraxias
Multiple Sclerosis
Sclerosis
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014