Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation
• Intervention / Treatment: Device: NTUH-ii, am upper limb rehabilitation robot arm; Other: Traditional upper limb physical therapy

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng Ting Lin, M.D.; Phone Number: +886-2312-3456 ext 67048; Email: mntinglin@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Meng Ting Lin, M.D.; Phone Number: +886-2312-3456 ext 67048; Email: mntinglin@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.	Before the task and right away the experiment, 3 months, 6 months post intervention.
sEMG analyzation	using sEMG sensors to obtain the sEMG signal and applying 3×2 ANOVA to analyze.	Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Modified Ashworth Scale	To measure the increase of muscle tone, score from 0 to 4, higher scores indicate the higher muscle tone.	Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Wolf Motor Function Test	To quantify upper extremity movement ability through timed single- or multiple-joint motions .and functional tasks.	Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Stroke Impact Scale	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.	Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Motor evoked potential	action potential elicited by noninvasive stimulation of the motor cortex	Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): December 22, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201905073DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No