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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: 19 February 2015
Main ID:  NCT02327767
Date of registration: 24/12/2014
Prospective Registration: Yes
Primary sponsor: California State University, Northridge
Public title: Use of a Mechanically Passive Rehabilitation Device in Vietnam: Impact on Upper Extremity Hemiparesis After Stroke
Scientific title: Use of a Mechanically Passive Rehabilitation Device as a Training Tool in Vietnam: Impact on Upper Extremity Hemiparesis After Stroke
Date of first enrolment: January 2015
Target sample size: 30
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT02327767
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Vietnam
Contacts
Name:     Thanh Do, MD
Address: 
Telephone: 011-84-905246877
Email: minhducdn2004@yahoo.com
Affiliation: 
Name:     Janna Beling, PhD, PT
Address: 
Telephone:
Email:
Affiliation:  California State University, Northridge
Name:     Janna Beling, PhD, PT
Address: 
Telephone: 818-677-7445
Email: janna.beling@csun.edu
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older

- diagnosis of stoke more than six months post injury

- patient in Da Nang, Vietnam

- <35 out of 66 on the UE-FMA

- ability to perform one complete repetition with the RAE

- participants' willingness to refrain from additional rehabilitation for the upper
extremities during the duration of the RAE portion of the study.

Exclusion Criteria:

- < 24 out of 30 on the Mini-Mental State Examination (MMSE) (Mitrushina, 1991)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cerebrovascular Accident
Intervention(s)
Device: Resonating Arm Exerciser
Primary Outcome(s)
Upper Extremity-Fugl Meyer Assessment (UE-FMA) [Time Frame: up to 6 weeks]
Secondary Outcome(s)
Wong Baker Faces Pain Rating Scale [Time Frame: Baseline, 3 weeks, 6 weeks]
Stroke Impact Scale [Time Frame: Baseline, 3 weeks, 6 weeks]
Secondary ID(s)
1314-153-a
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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