Use of a Mechanically Passive Rehabilitation Device in Vietnam: Impact on Upper Extremity Hemiparesis After Stroke
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of this project is to test a device (Zondervan et al, 2013) that can provide active assistance for arm training for people in Vietnam with severe to moderate stroke, but that is also simple and does not rely on powered actuators. The hypothesis is that individuals with a severe chronic stroke, who exercise with a mechanically passive rehabilitation device, will have improved arm movement ability without experiencing an increase in arm pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJanuary 5, 2015
January 1, 2015
2 months
December 24, 2014
January 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Upper Extremity-Fugl Meyer Assessment (UE-FMA)
The UE-FMA will assess sensorimotor performance of the volunteer's arm and takes 30-minutes to complete. This includes assessing reflex activity, volitional movement within synergy, volitional movement mixing synergies, volitional movement out of synergy, wrist movement, hand movement, coordination, sensation and proprioception (Fugl-Meyer, 1975). A score of \< 35/66 indicated moderate to severe impairments, which will be used as a baseline measure.
up to 6 weeks
Secondary Outcomes (2)
Stroke Impact Scale
Baseline, 3 weeks, 6 weeks
Wong Baker Faces Pain Rating Scale
Baseline, 3 weeks, 6 weeks
Study Arms (2)
Resonating Arm Exerciser
EXPERIMENTALThe treatment group will participate in supervised Resonating Arm Exerciser (RAE) group sessions of 45 minutes, three times a week, for a total of eight sessions for three consecutive weeks. During each treatment session, the affected upper extremity will be used to push on the lever of the RAE in the sagittal plane. Upon pushing and pulling on the lever, the wheelchair moves a total of 20 cm from a neutral position, which indicated a repetition counted by a programed iphone.
Physical Therapy
NO INTERVENTIONThe control group will continue with existing physical therapy treatment of passive range of motion (PROM) and therapeutic exercise to their involved upper extremity by the physical therapist.
Interventions
Participants in the exercise group will exercise using the device for 8 exercise sessions for 45 minutes per session for 3 consecutive weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \< 24 out of 30 on the Mini-Mental State Examination (MMSE) (Mitrushina, 1991)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DaNang Orthopedic and Rehabilitation Hospital
Da Nang, Vietnam
Related Publications (4)
Zondervan DK, Palafox L, Hernandez J, Reinkensmeyer DJ. The Resonating Arm Exerciser: design and pilot testing of a mechanically passive rehabilitation device that mimics robotic active assistance. J Neuroeng Rehabil. 2013 Apr 18;10:39. doi: 10.1186/1743-0003-10-39.
PMID: 23597303BACKGROUNDFugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PMID: 1135616BACKGROUNDVellone E, Savini S, Fida R, Dickson VV, Melkus GD, Carod-Artal FJ, Rocco G, Alvaro R. Psychometric evaluation of the Stroke Impact Scale 3.0. J Cardiovasc Nurs. 2015 May-Jun;30(3):229-41. doi: 10.1097/JCN.0000000000000145.
PMID: 24695074BACKGROUNDMitrushina M, Satz P. Reliability and validity of the Mini-Mental State Exam in neurologically intact elderly. J Clin Psychol. 1991 Jul;47(4):537-43. doi: 10.1002/1097-4679(199107)47:43.0.co;2-9.
PMID: 1939698BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janna Beling, PhD, PT
California State University, Northridge
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 24, 2014
First Posted
December 30, 2014
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
January 5, 2015
Record last verified: 2015-01