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Robot-assisted Hand Rehabilitation for Patients With Stroke

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ClinicalTrials.gov Identifier: NCT03392493
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Robot-assisted hand rehabilitation Behavioral: Standard treatment Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: AB or BA
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week)
 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.

Behavioral: 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.
Active Comparator: Group B
In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
 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.

Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Fugl-Meyer Assessment：Upper Limb section [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Upper Limb motor function


Secondary Outcome Measures :
  1. Box and block test [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Upper Limb motor function

  2. EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Grip strength

  3. Dynanometer [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Grip strength

  4. Semmes-Weinstein hand monofilament [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Light touch

  5. Revision of the Nottingham Sensory Assessment [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Proprioception

  6. Modified barthel index [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Activity of daily live ability


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392493


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Study Chair: Jui chi Lin, master Taipei Medical University, Taiwan, R.O.C.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Sgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015.
Pětioký, J. Robot-assisted therapy integrated with virtual reality for rehabilitation of hand function after stroke: a clinical case study. in the 20th ESPRM Congress 2016.
民國100年衛生統計系列(一)死因統計及衛生統計系列(四)全民健康保險醫療統計. 2011: 行政院衛生署.
O'Sullivan, S.B., T.J. Schmitz, and G. Fulk, Physical rehabilitation. 2013: FA Davis.
黃琬倩, et al., 不同雙側上肢訓練模式對中風復健成效之文獻回顧. 職能治療學會雜誌, 2009. 27(第 2): p. P29-P48.
Sharma, P., J.M. Sutaria, and P. Zambare, Effects of Neuromuscular Electrical Stimulation (NMES) on Hand Function in Stroke Patients. Indian Journal of Physiotherapy and Occupational Therapy-An International Journal, 2015. 9(3): p. 43-48.
Carey, L.M., Somatosensory loss after stroke. Critical Reviews™ in Physical and Rehabilitation Medicine, 1995. 7(1).
Buerger, S.P. and N. Hogan. Relaxing passivity for human-robot interaction. in 2006 IEEE/RSJ International Conference on Intelligent Robots and Systems. 2006. IEEE.
Hasegawa Y, M.Y., Watanabe K, Sankai Y, Five-fingered assistive hand with mechanical compliance of human finger. In IEEE Int. Conf.Robotics and Automation (ICRA). Pasadena, CA, 2008: p. 718-724.
Loureiro RCV, B.-L.J., Lima ER, Pons JL, Sanchez-Lacuesta JJ,Harwin WS, Upper limb tremor suppression in ADL via an orthosis incorporating a controllable double viscous beam actuator. In Proc. 9th Int. Conf. on Rehabilitation Robotics ICORR. Chicago, IL, 2005: p. 119-122.
Lincoln, N., J. Jackson, and S. Adams, Reliability and revision of the Nottingham Sensory Assessment for stroke patients. Physiotherapy, 1998. 84(8): p. 358-365.

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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03392493    
Other Study ID Numbers: TMU-JIRB N201704068
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University Shuang Ho Hospital:
Stroke
Robotic rehabilitation
Hand function
Activities of Daily Living
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases