Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke; Rehabilitation
• Interventions: Device: NTUH-ii, am upper limb rehabilitation robot arm; Other: Traditional upper limb physical therapy

• Registration Number: NCT06113380
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-25
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-12-22
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation by rehabilitation robot	NTUH-ii, am upper limb rehabilitation robot arm	Rehabilitation therapists will determine the training mode based on the subject's movement ability. Passive training mode Active-assistive training mode
Traditional rehabilitation	Traditional upper limb physical therapy	Traditional upper limb physical therapy is performed by the therapist.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment	1 month	Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Motor evoked potential	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
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.
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.
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan