Stroke RehabilitationNCT03773653

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

A study testing BMT to be combined with BAT, BMT to be combined with MT and BMT to be combined with IOT in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 5 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke Rehabilitation
What is being tested?: BMT to be combined with BAT, BMT to be combined with MT and BMT to be combined with IOT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 5 sitesTaiwan
Study dates: 12 Nov 2018to 25 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

⩾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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Taiwan5 sites

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
New Taipei City
Feng Yuan Hospital, Ministry of Health and Welfare
Taichung
National Taiwan University Hospital
Taipei
Taipei Hospital, Ministry of Health and Welfare
Taipei
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions: Stroke Rehabilitation
Being tested: BMT to be combined with BAT, BMT to be combined with MT, BMT to be combined with IOT
Keywords: stroke, robot-assisted therapy, mirror therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMT to be combined with BATBehavioural
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.
BMT to be combined with MTBehavioural
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.
BMT to be combined with IOTBehavioural
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.

Study groups in NCT03773653
Study group	Role	What they receive
BMT to be combined with BAT	Experimental	Participants in this group will receive bilateral robotic priming and bilateral arm training or mirror therapy within the 90-minute training sessions. Receives: Behavioral: BMT to be combined with BAT
BMT to be combined with MT	Experimental	Participants in this group will receive bilateral robotic priming and mirror therapy within the 90-minute training sessions. Receives: Behavioral: BMT to be combined with MT
BMT to be combined with IOT	Active comparator	Participants in this group will receive bilateral robotic priming and impairment-oriented training within one 90-minute training session. Receives: Behavioral: BMT to be combined with IOT

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Fugl-Meyer Assessment (FMA) at 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.
Measured: Baseline, 6 weeks, and 18 weeks
Change from Baseline ABILHAND Questionnaire at 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.
Measured: Baseline, 6 weeks, and 18 weeks
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 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.
Measured: Baseline, 6 weeks, and 18 weeks

Secondary outcomes (10)

Change from Baseline Goal Attainment Scaling (GAS) at 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.
Measured: Baseline and 6 weeks
Change from Baseline Functional Independence Measure (FIM) at 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.
Measured: Baseline and 6 weeks
Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 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.
Measured: Baseline and 6 weeks
Change from Baseline Activity level as evaluated by actigraphy at 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.
Measured: Baseline and 6 weeks
Change from Baseline Possible adverse response at 6 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.
Measured: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
The WMFT quantifies the motor functions of the upper limbs through timed and functional tasks.
Measured: Baseline and 6 weeks
Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 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.
Measured: Baseline and 6 weeks
Change from Baseline Medical Research Council scale (MRC) at 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.
Measured: Baseline and 6 weeks
Change from lateral pinch strength at 6 weeks
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.
Measured: Baseline and 6 weeks
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks
The CAHAI quantifies the bilateral motor functions of the upper limbs through and functional tasks.
Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201825 Apr 2023

First posted12 Dec 2018
Study start12 Nov 2018
Primary completion25 Apr 2023
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03773653
Sponsor's protocol ID: 201804087RINB
Status last verified: May 2022
First submitted: 13 Nov 2018
Last updated: 24 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
PubMed 38433459
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.
PubMed 35841056
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.
PubMed 34322077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Stroke, Upper Extremity Paresis
Recruiting
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Stroke, Ischemic
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Recruiting
Cervical tsDCS on Stroke Patients
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Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
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All Stroke Rehabilitation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
ClinicalTrials.gov ID: NCT03773653
Acronym / sponsor ID: 201804087RINB
Conditions: Stroke Rehabilitation
Keywords: stroke, robot-assisted therapy, mirror therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: 12 Nov 2018 (actual)
Primary completion: 25 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 12 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BMT to be combined with BAT	Experimental	Behavioral: BMT to be combined with BATParticipants in this group will receive bilateral robotic priming and bilateral arm training or mirror therapy within the 90-minute training sessions.
BMT to be combined with MT	Experimental	Behavioral: BMT to be combined with MTParticipants in this group will receive bilateral robotic priming and mirror therapy within the 90-minute training sessions.
BMT to be combined with IOT	Active comparator	Behavioral: BMT to be combined with IOTParticipants in this group will receive bilateral robotic priming and impairment-oriented training within one 90-minute training session.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

⩾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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMT to be combined with BATSpecifically, 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.	Behavioural	BMT to be combined with BAT
BMT to be combined with MTSimilar 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.	Behavioural	BMT to be combined with MT
BMT to be combined with IOTSimilar 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.	Behavioural	BMT to be combined with IOT

Primary outcome

Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
Time frame: Baseline, 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.
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.
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.

10 secondary outcomes

Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks.
Time frame: Baseline and 6 weeks
Change from Baseline Functional Independence Measure (FIM) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Activity level as evaluated by actigraphy at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Possible adverse response at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Medical Research Council scale (MRC) at 6 weeks
Time frame: Baseline and 6 weeks
Change from lateral pinch strength at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks
Time frame: Baseline and 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
Derived from this study: PubMed 38433459Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
Derived from this study: PubMed 35841056Lee 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.
Derived from this study: PubMed 34322077Li 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.

Related trials for Stroke Rehabilitation

Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Recruiting
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Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keh-chung Lin, ScD principal investigator

School of Occupational Therapy, National Taiwan University, Taipei, Taiwan

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks (time frame: Baseline, 6 weeks, and 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773653, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.