|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 September 2016 |
|
Main ID: |
NCT02297893 |
|
Date of registration:
|
17/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Improving Dexterous Skills in Parkinson's Disease
|
|
Scientific title:
|
Improving Dexterous Skills in Parkinson's Disease: A Randomized Controlled Trial |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
103 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02297893 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
René Müri, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Bern |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Behavioral: Theraband training program
|
|
Behavioral: Dexterity training program (HOMEDEXT)
|
|
Primary Outcome(s)
|
|
Nine Hole Peg Test
[Time Frame: 2 minutes]
|
|
Secondary Outcome(s)
|
|
Coin Rotation task
[Time Frame: 4 weeks]
|
|
Dexterity Questionnaire
[Time Frame: 4 weeks]
|
|
PDQ-39
[Time Frame: 4 weeks]
|
|
Modified MDS-UPDRS scale II
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
Luzerner Kantonsspital
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|