Actively Recruiting

Phase Not Applicable
Age: 20Years - 79Years
All Genders
ID06215625

Establishment of a Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries Using Exoskeleton Robot and IoT Platform

Led by National Cheng-Kung University Hospital · Updated on 2024-01-22

90

Participants Needed

2

Research Sites

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things (IoT) application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups: the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week; for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.

CONDITIONS

Brief Title

A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries

Who Can Participate

Age: 20Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For patients with stroke: 20-79 years old
  • Montreal Cognitive Assessment score of 26 or higher
  • Unilateral hemorrhagic or ischemic stroke diagnosis
  • Upper limb movement affected by brain cell damage
  • For patients with spinal cord injury: 20-65 years old
  • Mini-Mental Status Examination score of 25 or higher
  • Diagnosed with incomplete spinal cord injury at C5 or C6 level
Not Eligible

You will not qualify if you...

  • Surgery on shoulder, elbow, or wrist
  • Severe pain in upper limb
  • Other muscular or neurological diseases affecting motor performance

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants undergo a home-based upper limb rehabilitation program using either a smart exoskeleton robot system or task-oriented training. Stroke participants train 30 minutes twice daily, 5 days a week for 4 weeks. Spinal cord injury participants train 40 minutes once daily, 5 days a week for 4 weeks.

Training sessions occur at home 5 days a week for 4 weeks with assessments at baseline and after 4 weeks

Trial Site Locations

Total: 2 locations

1

National Cheng-Kung University Hospital

Tainan, Taiwan, 704

Actively Recruiting

2

Chi Mei Medical Center

Tainan, Taiwan, 710

Actively Recruiting

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Research Team

L

Li-Chieh Kuo, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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