Clinical trial NCT03392493: Robot-assisted Hand Rehabilitation for Patients With Stroke
Official title: The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robotic rehabilitation
Hand function
Activities of Daily Living
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: AB or BA
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.

Materials and Methods: 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) for hand evaluations, Modified Barthel Index for ADL ability. 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.

Eligibility criteria: Inclusion Criteria:

* First stroke with hemiplegia
* Chronicity \> 3 months
* Could understand the instructions
* Brunnstrom stageⅡ-Ⅴ
* Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile\< 2; Kinaesthetic \< 3)
* Modified Ashworth Scale \< 3

Exclusion Criteria:

* Age younger than 20 and older than75 years
* Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
* Individuals with other medical symptoms that can affect movement

Primary outcomes:
measure: Fugl-Meyer Assessment：Upper Limb section
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary outcomes:
measure: Box and block test
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
measure: EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
measure: Dynanometer
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
measure: Semmes-Weinstein hand monofilament
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
measure: Revision of the Nottingham Sensory Assessment
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
measure: Modified barthel index
timeFrame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Jui chi Lin, master
role: STUDY_CHAIR
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