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Robot-assisted Hand Rehabilitation for Patients With Stroke

NCT03392493 · Taipei Medical University Shuang Ho Hospital · Updated 3 Dec 2018

What is being tested
Robot-assisted hand rehabilitation; Standard treatment
For
Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 20 years to 75 years. About 25 people. The full rules are on the registry page.
Where
Taiwan
When
Starts or started 1 Feb 2018, ends 30 June 2018. Registered 8 Jan 2018.
Results
None posted yet.

In the researchers' words

Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
ClinicalTrials.gov, NCT03392493

Sites

  • Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical UniversityTaipei, Taiwan