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Robot-Assisted Therapy in Stroke Patients

Primary Purpose

Cerebrovascular Accidents, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robot-assisted therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accidents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment

Secondary Outcome Measures

Full Information

First Posted
June 8, 2009
Last Updated
July 8, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00917605
Brief Title
Robot-Assisted Therapy in Stroke Patients
Official Title
Robot-Assisted Upper Limb Rehabilitation in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accidents, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Robot-assisted therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Time Frame
before and after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3 to 24 months onset from a first-ever unilateral stroke an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers) be able to follow study instructions and perform study tasks without upper limb fracture within 3 months lack of participation in any experimental rehabilitation or drug studies during the study period willing to provide written informed consent Exclusion Criteria: subjects exhibiting physician-determined major medical problems or poor physical conditions that would interfere with participation subjects with excessive pain in any joint that might limit participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keh-chung Lin, ScD
Phone
886-2-33668180
Email
kehchunglin@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Organizational Affiliation
National Taiwan University Hospltal
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Phone
886-2-33668180

12. IPD Sharing Statement

Citations:
PubMed Identifier
23587106
Citation
Wu CY, Yang CL, Chen MD, Lin KC, Wu LL. Unilateral versus bilateral robot-assisted rehabilitation on arm-trunk control and functions post stroke: a randomized controlled trial. J Neuroeng Rehabil. 2013 Apr 12;10:35. doi: 10.1186/1743-0003-10-35.
Results Reference
derived
PubMed Identifier
22960277
Citation
Chuang LL, Lin KC, Wu CY, Chang CW, Chen HC, Yin HP, Wang L. Relative and absolute reliabilities of the myotonometric measurements of hemiparetic arms in patients with stroke. Arch Phys Med Rehabil. 2013 Mar;94(3):459-66. doi: 10.1016/j.apmr.2012.08.212. Epub 2012 Sep 4.
Results Reference
derived
PubMed Identifier
22895994
Citation
Hsieh YW, Wu CY, Lin KC, Yao G, Wu KY, Chang YJ. Dose-response relationship of robot-assisted stroke motor rehabilitation: the impact of initial motor status. Stroke. 2012 Oct;43(10):2729-34. doi: 10.1161/STROKEAHA.112.658807. Epub 2012 Aug 14.
Results Reference
derived
PubMed Identifier
22222143
Citation
Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.
Results Reference
derived

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Robot-Assisted Therapy in Stroke Patients

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