Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

National Taiwan University

Status: Enrolling

Conditions: Rehabilitation; Stroke

Treatments: Other: Traditional upper limb physical therapy; Device: NTUH-ii, am upper limb rehabilitation robot arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06113380

201905073DINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Rehabilitation by rehabilitation robot

Experimental group

Description:

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

Treatment:

Device: NTUH-ii, am upper limb rehabilitation robot arm

Traditional rehabilitation

Active Comparator group

Description:

Traditional upper limb physical therapy is performed by the therapist.

Treatment:

Other: Traditional upper limb physical therapy