Stroke RehabilitationNCT05492175
Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
A study testing robotic practice, kinetic exergaming and conventional therapy in people with Stroke Rehabilitation, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 4 sites in Taiwan.
Trial summary
This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- robotic practice, kinetic exergaming and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesTaiwan
- Study dates
- 17 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first ever-stroke≧3 months
- age range between 20 to 80 years
- baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
- no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
- able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
- can maintain a step-standing position for at least 30 seconds
- can walk for at least 10 meters with or without device
- no participation in further experimental rehabilitation or drug studies during the duration of the project
Who cannot join
- acute inflammation and pain
- concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites, 4 recruiting
- Recruiting
Feng Yuan Hospital, Ministry of Health and Welfare
Taichung
Keh-Chung Lin, ScD
- Recruiting
National Taiwan University Hospital
Taipei
Keh-Chung Lin, ScD
- Recruiting
Taipei Municipal Wan Fang Hospital
Taipei
Keh-Chung Lin, ScD
- Recruiting
Taipei Tzu Chi Hospital
Taipei
Keh-chung Lin, Sc.D, +886 33668180, kehchunglin@ntu.edu.tw
About this study
This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.
Read the detailed description
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. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming 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 the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.
- Conditions
- Stroke Rehabilitation
- Being tested
- robotic practice, kinetic exergaming, conventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic practiceOther
According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
kinetic exergamingOther
All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.
conventional therapyOther
Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on.
| Study group | Role | What they receive |
|---|---|---|
| proximal-prioritized robotic practice plus kinetic exergaming group | Experimental | 60 minutes per day, 3 days per week for 6 weeks Receives: Other: robotic practice; Other: kinetic exergaming |
| distal-prioritized robotic practice plus kinetic exergaming group | Active comparator | 60 minutes per day, 3 days per week for 6 weeks Receives: Other: robotic practice; Other: kinetic exergaming |
| robotic practice plus conventional therapy group | Active comparator | 60 minutes per day, 3 days per week for 6 weeks Receives: Other: robotic practice; Other: conventional therapy |
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.
- There are 33 UE items that assess movements and reflexes of the shoulder/elbow/forearm, wrist, and hand, and coordination/speed. Each item is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
- The maximum score is 66, with a subscale score of 42 for the proximal part of the arms (shoulder/elbow) and 24 for the distal part of the arm (wrist/hand/coordination)
- The higher summed score means the greater recovery of motor impairment.
Measured: Baseline, 6 weeks, and 18 weeks
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed.
Measured: Baseline, 6 weeks, and 18 weeks
Secondary outcomes (5)
Medical Research Council scale (MRC)
- MRC measures muscle power of the affected arm and is scored on a 6-point ordinal scale (0 = no contraction, 5 = resisted to maximal strength, full power compared with the unaffected side)
- The higher score means the greater muscle power.
Measured: Baseline, 6 weeks, and 18 weeks
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
- Accelerometry is used to measure human movement. These devices record patterns of motion and non-motion.
- All participants will be asked to wear the devices for 3 consecutive days before and after the intervention.
- .The accelerometer will record the number of movements per minute, and the mean counts of movements per minute will be calculated.
- The higher mean counts of movements per minute means the more activity of arm.
Measured: Baseline, 6 weeks, and 18 weeks
Functional Independence Measure (FIM)
- The FIM consists of 18 items grouped into 6 sub-scales, including self-care, sphincter control, transfer, locomotion, communication, and social cognition.
- Each item is rated from 1 (full assistance) to 7 (full independence), according to the level of support required to perform the tasks.
- A higher score (maximum score of 126) indicates a lower disability.
Measured: Baseline, 6 weeks, and 18 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
- The SSEQ will be used to gauge participants' confidence in their functional performance after stroke.
- It includes 13 items and gives an overview of the factors that influence functional performance.
- Each item will be assigned according to the perceived confidence rating on the scale of 0 (no confidence at all) to 10 (full confidence).
- The higher summed score means the more confidence of participant.
Measured: Baseline, 6 weeks, and 18 weeks
Adverse events (pain and fatigue)
- Self-reported fatigue and pain severity will be evaluated using the 10-cm vertical line in the Face Rating Scale for adverse effects.
- The participants will rate the level of their pain and fatigue after the intervention on an 11-point ordinal scale (0 = no pain/fatigue; 10 = the most severe pain/fatigue).
- The higher score means the more pain or fatigue of participant.
Measured: through study completion, an average of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start17 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keh-Chung Lin, Sc.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492175
- Sponsor's protocol ID
- 10-M-161
- Status last verified
- Feb 2025
- First submitted
- 3 Jul 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05492175
- Acronym / sponsor ID
- 10-M-161
- Conditions
- Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2022 (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.
This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.
Detailed description
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. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming 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 the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| proximal-prioritized robotic practice plus kinetic exergaming group | Experimental | Other: robotic practice, Other: kinetic exergaming60 minutes per day, 3 days per week for 6 weeks |
| distal-prioritized robotic practice plus kinetic exergaming group | Active comparator | Other: robotic practice, Other: kinetic exergaming60 minutes per day, 3 days per week for 6 weeks |
| robotic practice plus conventional therapy group | Active comparator | Other: robotic practice, Other: conventional therapy60 minutes per day, 3 days per week for 6 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- a first ever-stroke≧3 months
- age range between 20 to 80 years
- baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
- no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
- able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
Key exclusion criteria (2 listed)
- acute inflammation and pain
- concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
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 |
|---|---|---|
| robotic practiceAccording to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively. | Other | distal-prioritized robotic practice plus kinetic exergaming group, proximal-prioritized robotic practice plus kinetic exergaming group, robotic practice plus conventional therapy group |
| kinetic exergamingAll of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed. | Other | distal-prioritized robotic practice plus kinetic exergaming group, proximal-prioritized robotic practice plus kinetic exergaming group |
| conventional therapyParticipants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on. | Other | robotic practice plus conventional therapy group |
Primary outcome
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks
Time frame: Baseline, 6 weeks, and 18 weeks
1. The upper-extremity subscale of the FMA will be used to assess motor impairment. 2. There are 33 UE items that assess movements and reflexes of the shoulder/elbow/forearm, wrist, and hand, and coordination/speed. Each item is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). 3. The maximum score is 66, with a subscale score of 42 for the proximal part of the arms (shoulder/elbow) and 24 for the distal part of the arm (wrist/hand/coordination) 4. The higher summed score means the greater recovery of motor impairment.
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
Time frame: Baseline, 6 weeks, and 18 weeks
1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. 2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed.
5 secondary outcomes
Medical Research Council scale (MRC)
Time frame: Baseline, 6 weeks, and 18 weeks
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
Time frame: Baseline, 6 weeks, and 18 weeks
Functional Independence Measure (FIM)
Time frame: Baseline, 6 weeks, and 18 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Time frame: Baseline, 6 weeks, and 18 weeks
Adverse events (pain and fatigue)
Time frame: through study completion, an average of 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
- Individual participant dataSharing planned: No
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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.
Keh-Chung Lin, Sc.D principal investigator
National Taiwan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic practice, kinetic exergaming and conventional therapy in people with Stroke Rehabilitation, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 4 sites in Taiwan.
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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keh-Chung Lin, Sc.D (+886-3366-8180, kehchunglin@ntu.edu.tw), or a site near the patient. 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 2 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 NCT05492175, which also lists 1 linked publication.
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 19 Feb 2025.