Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

NCT06113380 | Recruiting

• 1 other identifier: 201905073DINC
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment

  Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.

  1 month

Secondary Outcomes (6)

• Fugl-Meyer Assessment

  Before the task and right away the experiment, 3 months, 6 months post intervention.

• sEMG analyzation

  Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

• Modified Ashworth Scale

  Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

• Wolf Motor Function Test

  Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

• Stroke Impact Scale

  Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.

Study Arms (2)

Rehabilitation by rehabilitation robot

EXPERIMENTAL

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

Traditional rehabilitation

ACTIVE COMPARATOR

Traditional upper limb physical therapy is performed by the therapist.

Other: Traditional upper limb physical therapy

Interventions

NTUH-ii, am upper limb rehabilitation robot arm 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.

Rehabilitation by rehabilitation robot

Traditional upper limb physical therapy OTHER

Traditional upper limb physical therapy is performed by the therapist.

Traditional rehabilitation

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
• Able to understand and follow simple instructions.
• Able to maintain a sitting posture balance.
• Rank on the Brunnstrom Scale is between two and five.
• Both ischemic and hemorrhagic strokes are included.

You may not qualify if:

• Not yet fully conscious.
• Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
• Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
• Severe aphasia preventing compliance with researchers' instructions for this study.
• Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
• Patients with a severe systemic illness requiring bed rest.
• Patients with shoulder joint pathology unable to undergo exercise therapy.
• Patients with severe osteoporosis who have concerns about fractures during physical activity.
• Patients with arrhythmia and implanted cardiac pacemakers.
• Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Meng Ting Lin, M.D.

CONTACT

+886-2312-3456 ext 67048; mntinglin@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 2, 2023
• Study Start: October 25, 2023
• Primary Completion: December 22, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 4, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)