Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113380
• Other study ID #: 201905073DINC
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: October 2023
• Source: National Taiwan University Hospital
• Contact: Meng Ting Lin, M.D.
• Phone: +886-2312-3456 ext 67048
• Email: mntinglin[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: July 30, 2026
• Est. primary completion date: December 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

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.

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment	Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.	1 month
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.