- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773653
Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keh-chung Lin, ScD
- Phone Number: +886-2-3366-8180
- Email: kehchunglin@ntu.edu.tw
Study Locations
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New Taipei, Taiwan
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
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Taichung, Taiwan
- Feng Yuan Hospital, Ministry of Health and Welfare
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Taipei Hospital, Ministry of Health and Welfare
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Taoyuan, Taiwan
- Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
Time Frame: Baseline, 6 weeks, and 18 weeks
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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.
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Baseline, 6 weeks, and 18 weeks
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Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks
Time Frame: Baseline, 6 weeks, and 18 weeks
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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.
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Baseline, 6 weeks, and 18 weeks
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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
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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.
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Baseline, 6 weeks, and 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks.
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline Functional Independence Measure (FIM) at 6 weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline Activity level as evaluated by actigraphy at 6 weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline Possible adverse response at 6 weeks
Time Frame: Baseline and 6 weeks
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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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Baseline and 6 weeks
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Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
Time Frame: Baseline and 6 weeks
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The WMFT quantifies the motor functions of the upper limbs through timed and functional tasks.
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Baseline and 6 weeks
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Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline Medical Research Council scale (MRC) at 6 weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from lateral pinch strength at 6 weeks
Time Frame: Baseline and 6 weeks
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Lateral pinch strength will be used for measurement of muscle strength of the affected hand.
The higher score means the greater recovery of muscle strength on the pinch strength.
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Baseline and 6 weeks
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Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks
Time Frame: Baseline and 6 weeks
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The CAHAI quantifies the bilateral motor functions of the upper limbs through and functional tasks.
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Baseline and 6 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Keh-chung Lin, ScD, School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
Publications and helpful links
General Publications
- Lee YC, Li YC, Lin KC, Yao G, Chang YJ, Lee YY, Liu CT, Hsu WL, Wu YH, Chu HT, Liu TX, Yeh YP, Chang C. Effects of robotic priming of bilateral arm training, mirror therapy, and impairment-oriented training on sensorimotor and daily functions in patients with chronic stroke: study protocol of a single-blind, randomized controlled trial. Trials. 2022 Jul 15;23(1):566. doi: 10.1186/s13063-022-06498-0.
- Li YC, Lin KC, Chen CL, Yao G, Chang YJ, Lee YY, Liu CT. A Comparative Efficacy Study of Robotic Priming of Bilateral Approach in Stroke Rehabilitation. Front Neurol. 2021 Jul 12;12:658567. doi: 10.3389/fneur.2021.658567. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201804087RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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