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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Nine Hole Peg Test [ Time Frame: 2 minutes ]
- Coin Rotation task [ Time Frame: 4 weeks ]
- Modified MDS-UPDRS scale II [ Time Frame: 4 weeks ]
- PDQ-39 [ Time Frame: 4 weeks ]
- Dexterity Questionnaire [ Time Frame: 4 weeks ]
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
|Luzern, Switzerland, 6000|
|Study Chair:||René Müri, MD||University of Bern|