Clinical trial NCT06956677: Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
Official title: Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke
Keywords: Stroke
Hemiparesis
Usability
Bilateral Training
Upper Extremity Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An investigator analyzed inclusion and exclusion criteria and assigned participants to one of the groups. Participants were randomly allocated to either the experimental group or the control group. Randomization and group allocation was performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 3-week period, consisting of 10 to 15 sessions.
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
Secondary outcomes:
measure: Brunnstrom stage
timeFrame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
measure: Modified Ashworth scale
timeFrame: Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital
Study officials:
References:
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