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The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients

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ClinicalTrials.gov Identifier: NCT03624153
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand robotic training device on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in brain injury patients.

Condition or disease Intervention/treatment Phase
Chronic Stroke Behavioral: robotic-assisted training Behavioral: traditional occupational therapy Not Applicable

Detailed Description:

In the Robot-assisted group, participants receive training including passive movement, active movement, and game practices.

Let's see the operation of the robot system by video. First, the passive movement. Patients could perform a movement of full hand, or thumb/second/middle finger together.

Second, the active movement. There were three types of active movement, including full hand grasp/ release/ or grasp and release together.

The researcher chose two out of three of the movements. Third, the game mode. There were several games to practice the active movement, including only distal part/ or distal plus proximal part together.

In the Conventional group, participants receive conventional occupational therapy.

The intervention was conducted 1.5 hour a day, 3 days a week for consecutive 4 weeks.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of the EMG-driven Exoskeleton Hand Robotic Training Device on Upper Extremity Motor and Physiological Function, Daily Functions, Quality of Life and Self-efficacy in Brain Injury Patients
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Arm Intervention/treatment
Experimental: Robotic-assisted training
Participants in robotic-assisted training group will receive 1.5 hours/ day, 3 days a week, for 4 continuous weeks at the clinical setting. Participants will receive 10-minute of muscle tone normalization preparation and passive range of motion, then an 80-minute robotic-assisted training. After the end of the robotic-assisted training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks.Before and after the treatment, the evaluations were conducted. One month after the end of the treatment course, a follow-up evaluation will be assessed.
Behavioral: robotic-assisted training
Participant will practice about 80-minute robot-assisted training. The fingers motions will include flexion, extension, two fingers pinch and tripod pinch.

Active Comparator: Clinic-based therapy

Participants in clinic-based training group will receive 1.5 hours/ day, 3 days a week, for 4 continuous weeks at the clinical setting. Participants will receive traditional occupational therapy for 90 minutes. After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the Robot-assisted training for 4 continuous weeks.

Before and after the treatment, the evaluations were conducted. One month after the end of the treatment course, a follow-up evaluation will be assessed.

Behavioral: traditional occupational therapy
traditional occupational therapy with clinical rehabilitation tools




Primary Outcome Measures :
  1. Change scores of Fugl-Myer Assessment (FMA) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention ]
    The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.


Secondary Outcome Measures :
  1. Change scores of Mini-Mental State Exam (MMSE) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention. ]
    The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function.

  2. Change scores of Jamar hand dynamometer [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention. ]
    The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. It has the most extensive normative data. Excellent concurrent validity of the Jamar hand dynamometer is reported.

  3. Change scores of Modified Ashworth Scale (MAS) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention. ]
    The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors. The validity and reliability of MAS for patients with stroke were established to be adequate to good.

  4. Change scores of stroke self-efficacy questionnaire (SSEQ) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention ]
    the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population. It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy. Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.

  5. Change scores of Wolf Motor Function Test (WMFT) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention ]
    The WMFT is a reliable method to evaluate the UE motor ability in patients after stroke. The WMFT contains 15 function-based tasks and 2 strength-based tasks. The time (WMFT-time) and the functional ability (WMFT-quality) for an individual to complete the tasks will be recorded. A shorter WMFT-time and a larger WMFT-quality score indicate a faster movement and better quality of movement, respectively.

  6. Change scores of Motor Activity Log (MAL) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention ]
    The MAL will be used to assess the amount of use (AOU) and quality of movement (QOM) of the paretic UE. The MAL is a semi-structured interview that tests object manipulation and gross motor activities of daily living. The psychometric properties of MAL have been well-established, and a higher MAL score indicates better movement quality.

  7. Change scores of Action Research Arm Test (ARAT) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention ]
    The Action Research Arm Test (ARAT) evaluates 19 tests of arm motor function, both distally and proximally. Each test is given an ordinal score of 0, 1, 2, or 3, with higher values indicating better arm motor status. The total ARAT score is the sum of the 19 tests, and thus the maximum score is 57.

  8. Change scores of Quality of Life Scale (EQ-5D) [ Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 1 months after the completion of intervention. ]
    The EQ-5D is a five-dimensional health state classification. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These five dimensions are each assessed by a single question on a three point ordinal scale (no problems, some problems, extreme problems).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Brain injury more than 3 months.
  2. unilateral paresis (FMA score<60)
  3. no serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
  4. can provide informed consent

Exclusion Criteria:

  1. Modified Ashworth Scale>3
  2. Other neurological disease
  3. Inability to understand instructions
  4. current participation in any other research
  5. Botulinum Toxin injection within 3 months

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): NCT03624153


Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ching-Yi Wu Chang Gung University

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03624153     History of Changes
Other Study ID Numbers: 201701543B0
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries