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Improving Dexterous Skills in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02297893
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Tim Vanbellingen, Luzerner Kantonsspital

Brief Summary:

Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as buttoning a T-shirt or hand-writing. The aim of the present research project is to investigate the effectiveness of a high intensity home based exercise intervention focusing on fine motor skills (HOMEDEXT), in patients with PD.

Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization will be done by an independent biostatistician who will use a computerized randomization protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks later, will be done to assess long-lasting effects. Assessments will be performed by investigators who are blinded for the intervention.

Participants: One hundred and four out-patients with PD will be recruited who report specific difficulties in manual dexterity when executing ADL. Intervention: The patients will be allocated to either an intervention group (n = 52) or control group (n = 52). In the intervention group PD patients will exercise, over a period of four weeks, once/day during 30 minutes a treatment with specific exercises for dexterity. The PD patients, who will be allocated to the control group, will exercise Theraband exercises.

Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole Peg test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening for dexterity. Furthermore for ADL a modified version of the subscale II of the Movement Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will be used.


Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Dexterity training program (HOMEDEXT) Behavioral: Theraband training program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Dexterous Skills in Parkinson's Disease: A Randomized Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexterity training program (HOMEDEXT)
This program is a a high intensity training program adapted from a previously published arm ability training program
Behavioral: Dexterity training program (HOMEDEXT)
The dexterity training program contains 7 exercises which focus on improving fine motor skills.

Active Comparator: Theraband training program
7 different Theraband exercises. Total duration is 30 minutes, trained 5 times a week over a period of 4 weeks
Behavioral: Theraband training program
The Theraband training program contains 7 exercises which focus on improving upper limb strength




Primary Outcome Measures :
  1. Nine Hole Peg Test [ Time Frame: 2 minutes ]

Secondary Outcome Measures :
  1. Coin Rotation task [ Time Frame: 4 weeks ]
  2. Modified MDS-UPDRS scale II [ Time Frame: 4 weeks ]
  3. PDQ-39 [ Time Frame: 4 weeks ]
  4. Dexterity Questionnaire [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be included if they fulfill the criteria defined by the UK Parkinson's Disease Society Brain Bank Criteria (Hughes et al. 1992), with Hoehn and Yahr stages II to IV.

Exclusion Criteria:

  • Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA) (Gill et al. 2008)
  • Patients who received OT in the last 12 months to avoid carryover effects
  • Inability to complete questionnaires (i.e. due to cognitive problems)
  • Participation in another intervention trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297893


Locations
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Switzerland
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
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Study Chair: René Müri, MD University of Bern
Publications:
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Responsible Party: Tim Vanbellingen, Dr. phil., Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT02297893    
Other Study ID Numbers: Luzerner Kantonsspital
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases