Occupational Therapy in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507636
• Other study ID #: 042/11
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: May 14, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apraxia
• Apraxias
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Occupational Therapy
Occupational therapy using a special arm function training.
• Physical therapy
Physical therapy for arm force training.

Locations

Country	Name	City	State
Switzerland	Department of Neurology, Bern university Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Bohlhalter S, Vanbellingen T, Bertschi M, Wurtz P, Cazzoli D, Nyffeler T, Hess CW, Müri 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. — View Citation

Vanbellingen T, Kersten B, Van de Winckel A, Bellion M, Baronti F, Müri 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in apraxia score as measured by TULIA		From day of randomisation to end of study, expected to be after 4 weeks	No
Secondary	Change in manual dexterity	Measured by the coin rotation task and 9-hole-peg-test	From day of randomisation to end of study, expected to be after 4 weeks	No
Secondary	Change in activities of daily living	Measured by questionnaire	From day of randomisation to end of study, expected to be after 4 weeks	No
Secondary	Change in quality of life	Measured by questionnaire	From day of randomisation to end of study, expected to be after 4 weeks	No
Secondary	Change in fatigue	Measured by questionnaire	From day of randomisation to end of study, expected to be after 4 weeks	No