NCT03392493

Robot-assisted Hand Rehabilitation for Patients With Stroke

Completed NA Last updated 3 December 2018

What this trial tests

NA trial testing Robot-assisted hand rehabilitation in Stroke in 25 participants. Completed in 30 June 2018.

Timeline

1 February 2018

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Taipei Medical University Shuang Ho Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	25
Start date	1 February 2018
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across Taiwan

Drugs / interventions tested

• Robot-assisted hand rehabilitation
• Standard treatment

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Taipei Medical University Shuang Ho Hospital

Who can join

Adults 20 to 75, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.