Stroke Clinical Trial
Official title:
Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke
NCT number | NCT03229733 |
Other study ID # | CMRPG8E0931 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | December 2017 |
Verified date | February 2017 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
Status | Completed |
Enrollment | 39 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment - 3 months post stroke - Impaired arm motor function at Brunnstrom stage 3-5 - Age 18 years or older Exclusion Criteria: - severe cognitive impairment defined as < 20 on Mini Mental State Examination - visual disorders or neglect limiting the ability to comply with treatment regimen - orthopedic problem or other neurological diagnosis that makes the UE dysfunction. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. — View Citation
Noorkõiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144. Review. — View Citation
Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor function assessed on Fugl-Meyer Assessment (FMA) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | The amount of movement assessed on Actigraph Assessment | The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment. | Change from baseline at 2 months | |
Secondary | The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | The quality of movement and amount of use assessed on Motor Activity Log (MAL) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | Standing balance assessed on The Functional reach test (FR) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months | |
Secondary | Muscle power assessed on Medical Research Council Scale (MRC) | The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment. | Change from baseline at 5 months |
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