Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation

February 18, 2025 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • Feng Yuan Hospital, Ministry of Health and Welfare
        • Contact:
          • Keh-Chung Lin, ScD
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Keh-Chung Lin, ScD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Municipal Wan Fang Hospital
        • Contact:
          • Keh-Chung Lin, ScD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Tzu Chi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. a first ever-stroke≧3 months
  2. age range between 20 to 80 years
  3. baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
  4. no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
  5. able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
  6. can maintain a step-standing position for at least 30 seconds
  7. can walk for at least 10 meters with or without device
  8. no participation in further experimental rehabilitation or drug studies during the duration of the project

Exclusion Criteria:

  1. acute inflammation and pain
  2. concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: proximal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
Other: robotic practice
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.
Other: kinetic exergaming
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.
Active Comparator: distal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
Other: robotic practice
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.
Other: kinetic exergaming
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.
Active Comparator: robotic practice plus conventional therapy group
60 minutes per day, 3 days per week for 6 weeks
Other: robotic practice
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.
Other: conventional therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
  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.
Baseline, 6 weeks, and 18 weeks
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.
Baseline, 6 weeks, and 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medical Research Council scale (MRC)
Time Frame: Baseline, 6 weeks, and 18 weeks
  1. 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)
  2. The higher score means the greater muscle power.
Baseline, 6 weeks, and 18 weeks
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
Time Frame: Baseline, 6 weeks, and 18 weeks
  1. Accelerometry is used to measure human movement. These devices record patterns of motion and non-motion.
  2. All participants will be asked to wear the devices for 3 consecutive days before and after the intervention.
  3. .The accelerometer will record the number of movements per minute, and the mean counts of movements per minute will be calculated.
  4. The higher mean counts of movements per minute means the more activity of arm.
Baseline, 6 weeks, and 18 weeks
Functional Independence Measure (FIM)
Time Frame: Baseline, 6 weeks, and 18 weeks
  1. The FIM consists of 18 items grouped into 6 sub-scales, including self-care, sphincter control, transfer, locomotion, communication, and social cognition.
  2. Each item is rated from 1 (full assistance) to 7 (full independence), according to the level of support required to perform the tasks.
  3. A higher score (maximum score of 126) indicates a lower disability.
Baseline, 6 weeks, and 18 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Time Frame: Baseline, 6 weeks, and 18 weeks
  1. The SSEQ will be used to gauge participants' confidence in their functional performance after stroke.
  2. It includes 13 items and gives an overview of the factors that influence functional performance.
  3. Each item will be assigned according to the perceived confidence rating on the scale of 0 (no confidence at all) to 10 (full confidence).
  4. The higher summed score means the more confidence of participant.
Baseline, 6 weeks, and 18 weeks
Adverse events (pain and fatigue)
Time Frame: through study completion, an average of 18 weeks
  1. Self-reported fatigue and pain severity will be evaluated using the 10-cm vertical line in the Face Rating Scale for adverse effects.
  2. 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).
  3. The higher score means the more pain or fatigue of participant.
through study completion, an average of 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keh-Chung Lin, Sc.D, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-M-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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