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Clinical Trials/NCT06113380
NCT06113380
Recruiting
N/A

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

National Taiwan University Hospital1 site in 1 country68 target enrollmentOctober 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
National Taiwan University Hospital
Enrollment
68
Locations
1
Primary Endpoint
Fugl-Meyer Assessment
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2023
End Date
July 30, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment

Time Frame: 1 month

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

Secondary Outcomes

  • sEMG analyzation(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
  • Wolf Motor Function Test(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
  • Motor evoked potential(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
  • Fugl-Meyer Assessment(Before the task and right away the experiment, 3 months, 6 months post intervention.)
  • Modified Ashworth Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
  • Stroke Impact Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)

Study Sites (1)

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