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Robot-assisted Hand Rehabilitation for Patients With Stroke

The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392493
Enrollment
25
Registered
2018-01-08
Start date
2018-02-01
Completion date
2018-06-30
Last updated
2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Robotic rehabilitation, Hand function, Activities of Daily Living

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.

Interventions

Robot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task.

BEHAVIORALStandard treatment

Standard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task.

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single Blind (Outcomes Assessor)

Intervention model description

AB or BA

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment:Upper Limb sectionChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthUpper Limb motor function

Secondary

MeasureTime frameDescription
Box and block testChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthUpper Limb motor function
DynanometerChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthGrip strength
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longusChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthGrip strength
Revision of the Nottingham Sensory AssessmentChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthProprioception
Modified barthel indexChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthActivity of daily live ability
Semmes-Weinstein hand monofilamentChange from baseline to 6 weeks, 10 weeks,16weeks, follow up at three monthLight touch

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026