Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06113380
Collaborator
(none)
68
1
2
9.2
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NTUH-ii, am upper limb rehabilitation robot arm
  • Other: Traditional upper limb physical therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients
Anticipated Study Start Date :
Oct 25, 2023
Anticipated Primary Completion Date :
Jul 22, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rehabilitation by rehabilitation robot

Rehabilitation therapists will determine the training mode based on the subject's movement ability. Passive training mode Active-assistive training mode

Device: NTUH-ii, am upper limb rehabilitation robot arm
Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.

Active Comparator: Traditional rehabilitation

Traditional upper limb physical therapy is performed by the therapist.

Other: Traditional upper limb physical therapy
Traditional upper limb physical therapy is performed by the therapist.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment [1 month]

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

Secondary Outcome Measures

  1. Fugl-Meyer Assessment [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.

  2. Able to understand and follow simple instructions.

  3. Able to maintain a sitting posture balance.

  4. Rank on the Brunnstrom Scale is between two and five.

  5. Both ischemic and hemorrhagic strokes are included.

Exclusion Criteria:
  1. Not yet fully conscious.

  2. Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.

  3. Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.

  4. Severe aphasia preventing compliance with researchers' instructions for this study.

  5. Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.

  6. Patients with a severe systemic illness requiring bed rest.

  7. Patients with shoulder joint pathology unable to undergo exercise therapy.

  8. Patients with severe osteoporosis who have concerns about fractures during physical activity.

  9. Patients with arrhythmia and implanted cardiac pacemakers.

  10. Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT06113380
Other Study ID Numbers:
  • 201905073DINC
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023