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Robot-Assisted Therapy in Stroke Patients

This study is currently recruiting participants.
Verified March 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00917605
First received: June 8, 2009
Last updated: July 8, 2012
Last verified: March 2012
History of Changes
  Purpose

This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke on various outcomes, (2) test the dose-response relations by using two different intensities (higher versus lower intensity RAT), and (3) investigate the effects of the training intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum of functioning including motor ability, motor control strategies, basic/extended daily functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the second part of study, the purposes are to define the appropriate populations for RAT and to examine the clinimetric properties of clinical measures relevant for use in robotic rehabilitation research. the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions. Finally, the investigators will examine and compare the clinimetric properties (e.g., validity and responsiveness) of the clinical measures of rehabilitation outcome to inform selection of test instruments that may detect clinically meaningful change after rehabilitation therapy.


Condition Intervention
Cerebrovascular Accidents
Stroke
 Other: Robot-assisted therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-Assisted Upper Limb Rehabilitation in Stroke

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:
  • Fugl-Meyer Assessment [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Robot-assisted therapy
    Patients will receive an intervention for 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The Robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany), will be used in this project. The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension (Hesse et al., 2003; Hesse et al., 2005). Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. Mode 3 is an active mode as in 2, but the paretic arm had to overcome an individually set, initially isometric resistance to allow the bilateral movement. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 3 to 24 months onset from a first-ever unilateral stroke
  2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment
  3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers)
  4. be able to follow study instructions and perform study tasks
  5. without upper limb fracture within 3 months
  6. lack of participation in any experimental rehabilitation or drug studies during the study period
  7. willing to provide written informed consent

Exclusion Criteria:

  1. subjects exhibiting physician-determined major medical problems or poor physical conditions that would interfere with participation
  2. subjects with excessive pain in any joint that might limit participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917605

Contacts
Contact: Keh-chung Lin, ScD 886-2-33668180 kehchunglin@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Keh-chung Lin , ScD     886-2-33668180        
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Keh-chung Lin, ScD National Taiwan University Hospltal
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00917605     History of Changes
Other Study ID Numbers: 200903080R
Study First Received: June 8, 2009
Last Updated: July 8, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 23, 2013