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

NCT06956677 | Completed DMC

• 1 other identifier: 202301097A3
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke

Keywords

Stroke; Hemiparesis; Usability; Bilateral Training; Upper Extremity Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for Upper Extremity

  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 Outcomes (2)

• Brunnstrom stage

  Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.

• Modified Ashworth scale

  Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.

Study Arms (2)

Control group

ACTIVE COMPARATOR

Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy.

Other: The UE functional training; Other: Conventional occupational therapy

Experimental group

EXPERIMENTAL

Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy.

Device: Novel UE rehabilitation device training; Other: Conventional occupational therapy

Interventions

Novel UE rehabilitation device training DEVICE

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.

Experimental group

The UE functional training OTHER

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.

Control group

Conventional occupational therapy OTHER

Conventional occupational therapy

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment
• Other neurological disorders
• Orthopedic conditions affecting the UE
• Active or non-healed dermatological lesions

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

New Taipei Municipal TuCheng Hospital

New Taipei City, 236, Taiwan

Location

Related Publications (16)

• Sahu RK, Gugnani A, Ahluwalia R. Short-term effectiveness of trunk and bimanual hand training on upper limb motor recovery and function in stroke patients. International journal of health sciences. 05/15 2022;6(S1):10058-10071. doi:10.53730/ijhs.v6nS1.7384

  RESULT

• Julien M, Laffont I, Bonnin H-Y, Liesjet V, Mottet D. Bimanual Coordination Being Efficient Around Two Months After Stroke: A Key Recovery Moment for Starting Bimanual Rehabilitation Protocols? BIO Web of Conferences. 12/01 2011;1doi:10.1051/bioconf/20110100062

  RESULT

• Metrot J, Mottet D, Hauret I, van Dokkum L, Bonnin-Koang HY, Torre K, Laffont I. Changes in bimanual coordination during the first 6 weeks after moderate hemiparetic stroke. Neurorehabil Neural Repair. 2013 Mar-Apr;27(3):251-9. doi: 10.1177/1545968312461072. Epub 2012 Nov 7.

  PMID: 23135767 RESULT

• Ma D, Li X, Xu Q, Yang F, Feng Y, Wang W, Huang JJ, Pei YC, Pan Y. Robot-Assisted Bimanual Training Improves Hand Function in Patients With Subacute Stroke: A Randomized Controlled Pilot Study. Front Neurol. 2022 Jul 6;13:884261. doi: 10.3389/fneur.2022.884261. eCollection 2022.

  PMID: 35873779 RESULT

• Shahid J, Kashif A, Shahid MK. A Comprehensive Review of Physical Therapy Interventions for Stroke Rehabilitation: Impairment-Based Approaches and Functional Goals. Brain Sci. 2023 Apr 25;13(5):717. doi: 10.3390/brainsci13050717.

  PMID: 37239189 RESULT

• Nair KPST, A B. Stroke rehabilitation : traditional and modern approaches. 2002;

  RESULT

• Tan CO. Is remote rehabilitation after stroke as effective as conventional therapy? Neurology. 2020 Oct 27;95(17):e2462-e2464. doi: 10.1212/WNL.0000000000010839. No abstract available.

  PMID: 33106363 RESULT

• Langhorne P, Legg L. Evidence behind stroke rehabilitation. J Neurol Neurosurg Psychiatry. 2003 Dec;74 Suppl 4(Suppl 4):iv18-iv21. doi: 10.1136/jnnp.74.suppl_4.iv18. No abstract available.

  PMID: 14645462 RESULT

• Johnson MJ, Rai R, Barathi S, Mendonca R, Bustamante-Valles K. Affordable stroke therapy in high-, low- and middle-income countries: From Theradrive to Rehab CARES, a compact robot gym. J Rehabil Assist Technol Eng. 2017 Jun 1;4:2055668317708732. doi: 10.1177/2055668317708732. eCollection 2017 Jan-Dec.

  PMID: 31186929 RESULT

• Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

  PMID: 30175845 RESULT

• Poli P, Morone G, Rosati G, Masiero S. Robotic technologies and rehabilitation: new tools for stroke patients' therapy. Biomed Res Int. 2013;2013:153872. doi: 10.1155/2013/153872. Epub 2013 Nov 20.

  PMID: 24350244 RESULT

• Trombly CA, Ma HI. A synthesis of the effects of occupational therapy for persons with stroke, Part I: Restoration of roles, tasks, and activities. Am J Occup Ther. 2002 May-Jun;56(3):250-9. doi: 10.5014/ajot.56.3.250.

  PMID: 12058514 RESULT

• Paci M, Nannetti L, Casavola D, Lombardi B. Differences in motor recovery between upper and lower limbs: does stroke subtype make the difference? Int J Rehabil Res. 2016 Jun;39(2):185-7. doi: 10.1097/MRR.0000000000000172.

  PMID: 27096715 RESULT

• Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.

  PMID: 3804600 RESULT

• McCrea PH, Eng JJ, Hodgson AJ. Biomechanics of reaching: clinical implications for individuals with acquired brain injury. Disabil Rehabil. 2002 Jul 10;24(10):534-41. doi: 10.1080/09638280110115393.

  PMID: 12171643 RESULT

• Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.

  PMID: 34986727 RESULT

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: September 5, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 4, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)