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Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773653
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
This comparative efficacy study will be based on a 3-armed controlled trial: bilateral robotic priming combined with bilateral arm training (bilateral RT+BAT), bilateral robotic priming combined with mirror therapy (bilateral RT+MT), and the control intervention (bilateral RT+IOT). The goal of this 4-year project is to provide scientific evidence of the comparative efficacy research of hybrid interventions based on unilateral vs. bilateral approach to upper limb rehabilitation in subacute and chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Behavioral: BMT to be combined with BAT Behavioral: BMT to be combined with MT Behavioral: BMT to be combined with IOT Not Applicable

Detailed Description:
This proposed research fits in the NHRI research priority 4-1 by addressing innovative treatment strategies for stroke that is in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that lead to long-term disability and causes heavy health care and financial burden. Advances in clinical and translational neurosciences have led to the new development of stroke rehabilitation. Current stroke rehabilitation programs such as robotic therapy, mirror therapy, and bilateral arm training are bilateral approaches to intensive practice based on the tenet of practice-dependent neuroplasticity. Bilateral robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. This proposed research project will: (1) examine the effects of bilateral robotic priming combined with bilateral arm training approach versus bilateral robotic priming combined with mirror therapy, relative to the control intervention approach (bilateral robotic priming combined with impairment-oriented training) on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of robotic priming combined with contemporary rehabilitation approaches (i.e., bilateral arm training and mirror therapy) and the control intervention, and (3) identify the potential predictors of functionally relevant changes after therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMT to be combined with BAT
Participants in this group will receive bilateral robotic priming and bilateral arm training or mirror therapy within the 90-minute training sessions.
Behavioral: BMT to be combined with BAT
Specifically, the participants will first receive 40 to 45 minutes of bilateral robotic priming using the BMT. After the robotic priming, participants will receive another 40 to 45 minutes training in tasks focusing on bilateral symmetric movements of both ULs.

Experimental: BMT to be combined with MT
Participants in this group will receive bilateral robotic priming and mirror therapy within the 90-minute training sessions.
Behavioral: BMT to be combined with MT
Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of mirror therapy.

Active Comparator: BMT to be combined with IOT
Participants in this group will receive bilateral robotic priming and impairment-oriented training within one 90-minute training session.
Behavioral: BMT to be combined with IOT
Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of impairment-oriented training.




Primary Outcome Measures :
  1. Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, and 18 weeks [ Time Frame: Baseline, 3 weeks, 6 weeks, and 18 weeks ]
    The upper-extremity subscale of the FMA will be used to assess motor impairment. FMA contains 33 items (scale 0-66). The higher summed score means the greater recovery of motor impairment.

  2. Change from Baseline Medical Research Council scale (MRC) at 3 weeks and 6 weeks [ Time Frame: Baseline, 3 weeks and 6 weeks ]
    MRC will be used for measurement of muscle strength of the affected arm. MRC contains 8 items (scale 0-40). The higher summed score means the greater recovery of muscle strength of the affected arm.

  3. Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    The rNSA will be used to evaluate changes in sensation. The rNSA using a 3-point or 4-point scale contains 72 items (scale 0-151) and is divided into tactile sensation, proprioception, and stereognosis subscales. The higher summed score means the greater recovery of sensory impairment.

  4. Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks [ Time Frame: Baseline, 6 weeks, and 18 weeks ]
    The ABILHAND Questionnaire will be used to evaluate the ability of the upper limb in functional activities. ABILHAND contains 23 items (scale 0-69). The higher average score means the greater recovery of the ability of the upper limb in functional activities.


Secondary Outcome Measures :
  1. Change from Baseline Goal Attainment Scaling (GAS) at 3 weeks and 6 weeks. [ Time Frame: Baseline, 3 weeks and 6 weeks ]
    The GAS will be used for measurement the achievement of each participant's expectation in the course of intervention. The individual intervention goals related to daily activity will be negotiated by the therapists and participants. For the goals potentially achievable and not overly ambitious, each goal will be rated on a 5-point ordinal scale with the level of attainment captured. The importance and the difficulty for each goal will be scored also based on a 3-point ordinal scale (1 to 3). The overall GAS score will be calculated by a following formula and a GAS summed score larger than 50 refers to an above-expected performance.

  2. Change from Baseline Functional Independence Measure (FIM) at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    The FIM consists of 18 items (scale 18-126) grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. The higher summed score means the greater recovery of functional independence.

  3. Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks [ Time Frame: Baseline, 6 weeks, and 18 weeks ]
    The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week.

  4. Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    The SSEQ will be used to measure participants' confidence in functional performance from stroke. It consists of 13 items (scale 0-130). A higher summed score (maximum score indicates higher self- efficacy in functional performance from stroke.

  5. Change from Baseline Activity level as evaluated by actigraphy at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    We will use the ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL, USA) to quantitatively measure the amount of use outside the laboratory settings. The accelerometer will record the number of moves each minute, and the average counts of move per minute will be calculated as the primary outcome measure.

  6. Change from Baseline Myoton Pro at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    The functional state of skeletal muscle will be objectively assessed by the Myoton PRO. Three trials of the assessed muscles will be recorded with a 1-second interval, and the average value will be calculated for analysis.

  7. Change from Baseline Possible adverse response at 6 weeks and 18 weeks. [ Time Frame: Baseline, 6 weeks and 18 weeks ]
    The vertical numerical rating scale supplemented with a faces rating scale (NRS-FRS) and a self-reported assessment will be provided to evaluate adverse effects on fatigue and pain severity, respectively. Both assessments using 11-point scale (0 = no fatigue/pain to 10 = worst possible fatigue/pain) will be applied.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(1) ⩾3 months onset from a first-ever unilateral stroke; (2) age range from 18 to 80 years; (3) baseline upper extremity motor score on the Fugl-Meyer Assessment >10 (Fugl-Meyer et al., 1975); (4) no severe spasticity in any joints of the affected arm (Modified Ashworth Scale ⩽ 3) (Charalambous, 2014); (5) able to follow study instructions (Mini Mental State Examination Score ⩾24) (Skidmore et al., 2010); (6) no serious vision deficits and no other neurologic or major orthopedic diseases; (7) able to participate in a rehabilitation intervention program for 6 weeks; and (8) no participation in other studies during the study period and willing to provide written informed consent.

Exclusion Criteria:

(1) acute inflammation and (2) major medical problems or poor physical conditions that might interfere with participation.


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): NCT03773653


Contacts
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Contact: Keh-chung Lin, ScD +886-2-3366-8180 kehchunglin@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Keh-chung Lin, ScD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Keh-chung Lin, ScD School of Occupational Therapy, National Taiwan University, Taipei, Taiwan

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03773653    
Other Study ID Numbers: 201804087RINB
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: June 2018

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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 National Taiwan University Hospital:
stroke, robot-assisted therapy, mirror therapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases