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Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01117194
First received: January 18, 2010
Last updated: December 20, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.


Condition Intervention Phase
Stroke
 Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Rehabilitation Robot for Upper Limbs, Component Project 5: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Barthel index, [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Modified Asworth Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • STREAM and PASS scales [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • shoulder range of motion, VAS [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: shoulder training, rehabilitation robot Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
Use an intelligent robot to assist upper limb rehabilitation.
Other Name: self-developed robotic arm
No Intervention: control group

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • stroke (1-3 months)
  • Brunnstrom Stage II-III
  • single, unilateral

Exclusion Criteria:

  • aphasic
  • shoulder impairment
  • severe osteoporosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117194

Contacts
Contact: Wen-Shiang Chen +886-2-2123456 ext 67087 wenshiang@gmail.com

Locations
Taiwan
Dpt. Physical Medicine and Rehabilitation, NTUH Recruiting
Taipei, Taiwan, 100
Contact: Wen-Shiang Chen     +886-2-2123456 ext 67087     wenshiang@gmail.com    
Principal Investigator: Wen-Shiang Chen, MD PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Shiang Chen, MD, PhD Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01117194     History of Changes
Other Study ID Numbers: 200804031D
Study First Received: January 18, 2010
Last Updated: December 20, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 18, 2013