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NCT Number: NCT06113380

Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Meng Ting Lin, M.D.

CONTACT

[email protected]

+886-2312-3456 ext 67048

About this study

NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.

The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.

However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
  • Able to understand and follow simple instructions.
  • Able to maintain a sitting posture balance.
  • Rank on the Brunnstrom Scale is between two and five.
  • Both ischemic and hemorrhagic strokes are included.

Exclusion criteria

  • Not yet fully conscious.
  • Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
  • Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
  • Severe aphasia preventing compliance with researchers' instructions for this study.
  • Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
  • Patients with a severe systemic illness requiring bed rest.
  • Patients with shoulder joint pathology unable to undergo exercise therapy.
  • Patients with severe osteoporosis who have concerns about fractures during physical activity.
  • Patients with arrhythmia and implanted cardiac pacemakers.
  • Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.

Treatment and study plan

NTUH-ii, am upper limb rehabilitation robot arm

Device

Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.

Traditional upper limb physical therapy

Other

Traditional upper limb physical therapy is performed by the therapist.

Primary outcomes

  1. Fugl-Meyer Assessment

    Time frame: 1 month

    Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.

Secondary outcomes

  1. Fugl-Meyer Assessment

    Time frame: Before the task and right away the experiment, 3 months, 6 months post intervention.

    Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.

  2. sEMG analyzation

    Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

    using sEMG sensors to obtain the sEMG signal and applying 3×2 ANOVA to analyze.

  3. Modified Ashworth Scale

    Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

    To measure the increase of muscle tone, score from 0 to 4, higher scores indicate the higher muscle tone.

  4. Wolf Motor Function Test

    Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

    To quantify upper extremity movement ability through timed single- or multiple-joint motions .and functional tasks.

  5. Stroke Impact Scale

    Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

    A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Score from 0 to 100, Higher scores indicate a better outcome.

  6. Motor evoked potential

    Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

    action potential elicited by noninvasive stimulation of the motor cortex

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Ting Lin, M.D.

CONTACT

[email protected]

+886-2312-3456 ext 67048

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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