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mCIMT and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects

Primary Purpose

Stroke, Hemispatial Neglect

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
mCIMT combined with or without eye patching
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) a single unilateral stroke with stable medical conditions; (2) presence of UN; (3) demonstration of the proximal part movement in the affected upper extremity and a minimum of 20 degrees of active wrist extension and 10 degrees of finger extension; (4) no severe aphasia that hampers command following; (5) no severe cognitive impairments (Mini-Mental State Examination score >= 22); (6) being right-handed premorbidly by self-report. Exclusion Criteria: -

Sites / Locations

  • Keh-chung LinRecruiting

Outcomes

Primary Outcome Measures

traditional motor function tests,
kinematic analysis,
a circle discrimination test,
and daily life function measures

Secondary Outcome Measures

Full Information

First Posted
November 14, 2005
Last Updated
December 20, 2005
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00253825
Brief Title
mCIMT and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects
Official Title
Modified Constraint-Induced Movement Therapy and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of the current study is to evaluate relative efficacy of (1)modified constraint-induced movement therapy (mCIMT) combined with eye patching, (2)mCIMT, and (3) traditional rehabilitation on motor, attentional, and activities of daily living functions in stroke patients with unilateral neglect (UN). UN represents a failure to respond or orient to stimuli presented contralateral to a brain lesion. Constraint-induced movement therapy is made up of a family of treatment that involve repeatedly practicing use of the affected limb and constraining use of the unaffected arm in the clinic and at home. mCIMT is an intervention based on modifications to conventional CIMT by distributing practice sessions to a longer period of time. mCIMT attempts to supplement the inadequacy of the current rehabilitation programs and to fit better into rehabilitation schedules. This technique has been suggested to be especially relevant for treatment of patients with UN.Half-field eye patching involves occlusion of the hemifield of both eyes (in the case of left UN, the right hemifields of both eyes). Patching the ipsilateral hemifield is believed to increase activation of the involved hemisphere, resulting in increased attention to the contralateral neglected side. Despite the promising relevance of mCIMT for rehabilitation of patients with hemiplegia, it remains unclear whether mCIMT is effective for alleviating UN. A further issue that warrants investigation is the combined effects of mCIMT and eye patching. Both approaches involve the use of controlled sensory input that may lead to increased activation of the lesioned hemisphere. Integration of both approaches may be more efficacious than mCIMT without direct intervention for UN. This project is proposed to study the combined effects of both approaches. It is hypothesized that combining both approaches will be more effective than mCIMT, which is hypothesized to be superior to traditional rehabilitation involving the same amount of therapy time. To test the hypotheses, 60 patients with unilateral stroke and UN will be recruited and randomly assigned to one of the three treatment groups (i.e., mCIMT and eye patching, mCIMT, and traditional rehabilitation). Testing for UN will include the use of the line bisection test, cancellation tasks, and examination for extinction to double simultaneous stimulations. The outcome measures will include traditional motor function tests, kinematic analysis, a circle discrimination test, and daily life functional measures. Each eligible participant will be tested before and immediately after the assigned intervention and at three months and six months after the treatment. Each type of treatment will be three-week long. Multivariate analysis of covariance will be used to analyze the obtained data in order to test for the relative effects of the three treatments. Each participant will be tested for motivation for participating in treatment sessions using the Pittsburgh Rehabilitation Participation Scale. It is hypothesized that patients with higher participation will improve more than those with lower participation. The uniqueness of this proposed project pertains to (1)modification of the CIMT protocol in a more feasible way; (2)concurrent use of mCIMT and eye patching for treating UN post stroke; and (3)use of kinematic analysis for detecting precise changes in motor behavior post intervention. Kinematic analysis is relevant for identifying trajectory control deficits that may accompany clinically "recovered" UN. Findings of this investigation will improve assessment and treatment for UN that is devastating to functional recovery from stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemispatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
mCIMT combined with or without eye patching
Primary Outcome Measure Information:
Title
traditional motor function tests,
Title
kinematic analysis,
Title
a circle discrimination test,
Title
and daily life function measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) a single unilateral stroke with stable medical conditions; (2) presence of UN; (3) demonstration of the proximal part movement in the affected upper extremity and a minimum of 20 degrees of active wrist extension and 10 degrees of finger extension; (4) no severe aphasia that hampers command following; (5) no severe cognitive impairments (Mini-Mental State Examination score >= 22); (6) being right-handed premorbidly by self-report. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keh-chung Lin, Sc.D
Phone
02-23123456
Ext
7572
Email
kclin@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, Sc.D
Organizational Affiliation
National Taiwan University, Department of Occupational therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keh-chung Lin
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin

12. IPD Sharing Statement

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mCIMT and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects

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