Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study (Synslai)

May 1, 2025 updated by: Chang Gung Memorial Hospital

Background and Study Aims Stroke is a leading cause of long-term disability worldwide, affecting millions of individuals each year. After experiencing a stroke, many patients face challenges with their upper limbs, resulting in difficulties in performing daily activities. This study aims to evaluate a new rehabilitation device designed to assist stroke patients with hemiparesis (weakness on one side of the body) in improving their upper limb function. The goal is to determine if this device can effectively support recovery while providing an affordable and accessible option for rehabilitation.

Who Can Participate? This study is open to adults aged between 18 and 70 years, regardless of sex. To participate, individuals must have a confirmed diagnosis of hemiplegic stroke, which means they must experience weakness in one side of the body. Participants should have had their stroke within the last 12 months and must be able to follow simple commands. Those with cognitive impairments, other neurological disorders, certain orthopedic conditions affecting the upper limb, or active skin issues will not be eligible.

What Does the Study Involve? Participants in this study will be randomly assigned to two groups: one group will use the new rehabilitation device, while the other will receive conventional occupational therapy. Both groups will undergo an assessment before and after the intervention to measure their improvement in upper limb function. The device encourages exercises that are essential for fostering movement recovery, while the conventional therapy focuses on traditional rehabilitation methods. Participants will have their upper limb function evaluated through established assessment tools to gauge progress.

What Are the Possible Benefits and Risks of Participating? By participating in this study, individuals may experience improvements in their upper limb function, leading to increased independence and enhanced quality of life. Additionally, participants will contribute to valuable research that could improve rehabilitation strategies for future stroke patients. While the rehabilitation device is designed to be safe, some individuals may experience mild discomfort or fatigue from the exercises. However, serious side effects are rare. Participants are encouraged to discuss any concerns with the research team.

Where Is the Study Run From? The study is being conducted at New Taipei Municipal TuCheng Hospital in Taiwan, specifically in the rehabilitation ward, where trained medical professionals oversee the research process.

When Is the Study Starting and How Long Is It Expected to Run For? The study commenced in September 2023 and is expected to continue through November 2024. This timeline allows for recruiting participants and thorough data collection to assess the device's effectiveness.

Who Is Funding the Study? This study does not have external funding and is being conducted independently by the researchers involved. All costs associated with the study, including participant care and device usage, are covered by the resources of the conducting institution.

Who Is the Main Contact?

For more information about this study, please contact:

Kuo-Cheng, Liu Position: Research Coordinator Email address: monhh159@gmail.com

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • 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 Locations

  • Taiwan
      • New Taipei City, Taiwan, 236
        • New Taipei Municipal TuCheng Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed stroke diagnosis by imaging, with onset within the past 12 months
  2. Age between 18 and 70 years
  3. Stable physiological and neurological status (no neurological deterioration and stable vital signs for ≥72 hours; complications resolved or medically managed)
  4. Adequate cognitive function to follow at least two-step commands
  5. Willingness to provide written informed consent
  6. Unilateral upper extremity (UE) hemiplegia
  7. Brunnstrom stage > I for proximal UE motor function
  8. UE muscle tone < 3 on the Modified Ashworth Scale

Exclusion Criteria:

  1. Cognitive impairment
  2. Other neurological disorders
  3. Orthopedic conditions affecting the UE
  4. Active or non-healed dermatological lesions

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy.
Other: The UE functional training
The UE functional training focuses on the affected arm, incorporating exercises such as push-pull boxes (standing or seated), alternating push-pull boxes, and hand-crank exercises.
Other: Conventional occupational therapy
Conventional occupational therapy
Experimental: Experimental group
Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy.
Other: Conventional occupational therapy
Conventional occupational therapy
Device: Novel UE rehabilitation device training
The novel UE rehabilitation device training includes the single-joint exercise and dual-joint exercise, each performed 20 repetitions per set, for a total of 5 sets with 30-second rest intervals between sets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment for Upper Extremity
Time Frame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brunnstrom stage
Time Frame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
The Brunnstrom scale classifies motor recovery post-stroke into six stages, ranging from flaccid paralysis (Stage I) to near-normal voluntary control (Stage VI), and the higher stage represent the better outcome.
Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
Modified Ashworth scale
Time Frame: Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.
This scale assesses the severity of muscle spasticity by quantifying resistance to passive movement on a scale from 0 (no increase in tone) to 4 (rigid in flexion or extension) and the higer scores represent the worse outcome.
Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 5, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301097A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated during and/or analysed during the current study were available upon request from

  • Contact Name and Email Address: Dr. Kuo-Cheng Liu, email: monhh159@gmail.com
  • Type of Data Shared: Individual participant data (IPD) including demographic, assessments, interventions.
  • Availability: The dataset will be available upon request after the publication of study results.
  • Access Criteria: Researchers can request data by providing a brief description of their intended analysis, which should align with stroke rehabilitation research objectives.
  • Consent from Participants: Informed consent was obtained.
  • Anonymization Comments: Data will be anonymized to protect participant identities.
  • Ethical or Legal Restrictions: Following ethical guidelines and IRB requirements will guide the data-sharing process.
  • Other Comments: Participants' consents specify academic and appropriate use of data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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