Occupational Therapy in Patients With Multiple Sclerosis

NCT01507636 | Completed

• 1 other identifier: 042/11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Apraxia

Keywords

apraxia; occupational therapy; multiple sclerosis; manual dexterity

Outcome Measures

Primary Outcomes (1)

• Change in apraxia score as measured by TULIA

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

Secondary Outcomes (4)

• Change in manual dexterity

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

• Change in activities of daily living

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

• Change in quality of life

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

• Change in fatigue

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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Occupational therapy using a special arm function training.

Other: Occupational Therapy

Group 2

ACTIVE COMPARATOR

Physical therapy using the Theraband for training of force.

Other: Physical therapy

Interventions

Occupational Therapy OTHER

Occupational therapy using a special arm function training.

Group 1

Physical therapy OTHER

Physical therapy for arm force training.

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with all forms of MS
• Age 18-60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurology, Bern university Hospital

Bern, 3010, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 20935324 BACKGROUND

• 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.

  PMID: 21130031 BACKGROUND

• 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.

  PMID: 25623246 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Apraxias

Interventions

Occupational Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Christian P Kamm, MD

  Department of Neurology, Inselspital Bern, 3010 Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

CH (1)