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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00253825
First received: November 14, 2005
Last updated: December 20, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Stroke
Hemispatial Neglect
Device: mCIMT combined with or without eye patching
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Modified Constraint-Induced Movement Therapy and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • traditional motor function tests,
  • kinematic analysis,
  • a circle discrimination test,
  • and daily life function measures

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253825

Contacts
Contact: Keh-chung Lin, Sc.D 02-23123456 ext 7572 kclin@ha.mc.ntu.edu.tw

Locations
Taiwan
Keh-chung Lin Recruiting
Taipei, Taiwan
Contact: Keh-chung Lin         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Keh-chung Lin, Sc.D National Taiwan University, Department of Occupational therapy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00253825     History of Changes
Other Study ID Numbers: 9361701254
Study First Received: November 14, 2005
Last Updated: December 20, 2005
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on October 22, 2014