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Occupational Therapy in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Apraxia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Occupational Therapy
Physical therapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring apraxia, occupational therapy, multiple sclerosis, manual dexterity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurology, Bern university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Occupational therapy using a special arm function training.

Physical therapy using the Theraband for training of force.

Outcomes

Primary Outcome Measures

Change in apraxia score as measured by TULIA

Secondary Outcome Measures

Change in manual dexterity
Measured by the coin rotation task and 9-hole-peg-test
Change in activities of daily living
Measured by questionnaire
Change in quality of life
Measured by questionnaire
Change in fatigue
Measured by questionnaire

Full Information

First Posted
January 4, 2012
Last Updated
May 14, 2013
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01507636
Brief Title
Occupational Therapy in Patients With Multiple Sclerosis
Official Title
Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Apraxia
Keywords
apraxia, occupational therapy, multiple sclerosis, manual dexterity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Occupational therapy using a special arm function training.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Physical therapy using the Theraband for training of force.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Description
Occupational therapy using a special arm function training.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy for arm force training.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in manual dexterity
Description
Measured by the coin rotation task and 9-hole-peg-test
Time Frame
From day of randomisation to end of study, expected to be after 4 weeks
Title
Change in activities of daily living
Description
Measured by questionnaire
Time Frame
From day of randomisation to end of study, expected to be after 4 weeks
Title
Change in quality of life
Description
Measured by questionnaire
Time Frame
From day of randomisation to end of study, expected to be after 4 weeks
Title
Change in fatigue
Description
Measured by questionnaire
Time Frame
From day of randomisation to end of study, expected to be after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian P Kamm, MD
Organizational Affiliation
Department of Neurology, Inselspital Bern, 3010 Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Bern university Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20935324
Citation
Vanbellingen T, Kersten B, Van de Winckel A, Bellion M, Baronti F, Muri R, Bohlhalter S. A new bedside test of gestures in stroke: the apraxia screen of TULIA (AST). J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):389-92. doi: 10.1136/jnnp.2010.213371. Epub 2010 Oct 9.
Results Reference
background
PubMed Identifier
21130031
Citation
Bohlhalter S, Vanbellingen T, Bertschi M, Wurtz P, Cazzoli D, Nyffeler T, Hess CW, Muri R. Interference with gesture production by theta burst stimulation over left inferior frontal cortex. Clin Neurophysiol. 2011 Jun;122(6):1197-202. doi: 10.1016/j.clinph.2010.11.008. Epub 2010 Dec 3.
Results Reference
background
PubMed Identifier
25623246
Citation
Kamm CP, Mattle HP, Muri RM, Heldner MR, Blatter V, Bartlome S, Luthy J, Imboden D, Pedrazzini G, Bohlhalter S, Hilfiker R, Vanbellingen T. Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial. Mult Scler. 2015 Oct;21(12):1546-56. doi: 10.1177/1352458514565959. Epub 2015 Jan 26.
Results Reference
derived

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Occupational Therapy in Patients With Multiple Sclerosis

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