Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

NCT ID: NCT06113380

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2026-07-30

Brief Summary

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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

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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.

Conditions

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Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

NTUH-ii, am upper limb rehabilitation robot arm

Intervention Type DEVICE

Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.

Traditional rehabilitation

Traditional upper limb physical therapy is performed by the therapist.

Group Type ACTIVE_COMPARATOR

Traditional upper limb physical therapy

Intervention Type OTHER

Traditional upper limb physical therapy is performed by the therapist.

Interventions

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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.

Intervention Type DEVICE

Traditional upper limb physical therapy

Traditional upper limb physical therapy is performed by the therapist.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Meng Ting Lin, M.D.

Role: CONTACT

+886-2312-3456 ext 67048

Facility Contacts

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Meng Ting Lin, M.D.

Role: primary

+886-2312-3456 ext 67048

Other Identifiers

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201905073DINC

Identifier Type: -

Identifier Source: org_study_id

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