Robot-assisted Hand Rehabilitation for Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392493
• Other study ID #: TMU-JIRB N201704068
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2018
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• First stroke with hemiplegia

• Chronicity > 3 months

• Could understand the instructions

• Brunnstrom stage?-?

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Robot-assisted hand rehabilitation
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.
• Standard 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment:Upper Limb section	Upper Limb motor function	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	Box and block test	Upper Limb motor function	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus	Grip strength	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	Dynanometer	Grip strength	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	Semmes-Weinstein hand monofilament	Light touch	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	Revision of the Nottingham Sensory Assessment	Proprioception	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary	Modified barthel index	Activity of daily live ability	Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month