Cerebrovascular Accidents Clinical Trial
Official title:
Effect of Combined Therapy on Neglect Syndrome in Stroke Patients
Verified date | July 2012 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
The purpose of the current study is to evaluate motor and neglect recovery of stroke patients produced by CIT using kinematic and oculomotor assessment, together with conventional clinical measures.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - a clinical cerebrovascular of right cerebral accident patients - the age over 18-year-old - demonstration of Brunnstrom stage III of the affected upper extremity - patients with perceptual deficits - no severe cognitive disorder, could understand and follow orders - no severe equilibrium problems which will influence the intervention Exclusion Criteria: - recurrent of the stroke or epilepsy during the intervention - patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder - injected the Botox into the affected upper extremity during the past 6 months - participate in the other interventional study in the same time - refuse subscribed the informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Kwei-shan, Toayuan county |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | National Health Research Institutes, Taiwan, National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Catherine Bergego Scale (CBS) | The CBS is a therapist-designed checklist to examine the effect of neglect syndrome on a patient's daily function in 10 real-life situations, such as grooming, dressing, or maneuvering a wheelchair. A 4-point scale is used in each item, ranging from 0 (no neglect) to 3 (severe neglect). Patients with a total score of 0 were considered as having no neglect in performing daily activities. | 2008-2009 | No |
Secondary | Clinical measures at the impairment, activity, participation levels | 2008-2009 | No | |
Secondary | Eye movement analysis | An eye tracker system (Tobii 1750, with 1024 × 768 resolutions a 1 nd 30-Hz sampling rate) was used to record the participant's eye movement by detecting his or her pupil. To examine the possible improvement in abnormal eye movement after the intervention, the eye movement parameters included the fixation amplitude (the distance between the most left and the most right fixation points), the number of fixation points, and the fixation time in the left area (Left fixation points and Left fixation time). A fixation point is defined as the gaze point stays in 50 pixels on the screen over 30 ms and can be screened by a fixation filter function in the ClearView 2.0. A wider fixation amplitude, larger L fixation points, and longer L fixation time represent the alleviated syndrome of neglect. | 2008-2009 | No |
Secondary | kinematic variables | Kinematic analysis was used to detect UE and trunk movement. A 7-camera motion-analysis system (VICON MX; Oxford Metrics Inc., Oxford, UK)6 was linked to a personal computer to capture the movement of markers. Reference markers were placed on the seventh cervical vertebra (C7), the fourth thoracic vertebra (T4), the bilateral clavicles, midsternum, and the unaffected side of the acromion, middle of the humerus, lateral epicondyle,styloid process of the ulna and radius, and index nail. Kinematic variables included reaction time (second), normalized movement time (second), normalized total distance (mm), percentage of movement time where peak velocity (PPV) occurs, and trunk lateral shift. | 2008-2009 | No |
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