Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

Cerebrovascular Accidents Clinical Trial

Official title:

Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784706
• Other study ID #: 97-1391B
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: August 26, 2012
• Start date: October 2008
• Est. completion date: October 2009

Study information

• 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

Clinical Trial Summary

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.

Description:

This project will be carried out using a short term constraint and training protocol targeting at subacute and chronic patients with motor and perceptual deficits. The outcome measures will include kinematic and oculomotor analyses, which have not been employed yet.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accidents
• Stroke

Intervention

Other:
• EP
Participants were asked to wear glasses with a patch on the right lens to block the visual stimuli from the right side and force them to receive the stimuli from the left-side visual field.
• CIT
The CIT addressed forced use of the affected UE and restricted the unaffected UE during training. Shaping skills were delivered while participants were forced to use their affected UE in the mass practice of functional tasks, such as drinking water and opening a jar. Participants wore a mitt on their unaffected hand and wrist for 6 hours/day during the 3-week training and reported their compliance in a daily log.
• conventional therapy
Traditional occupational therapy matched in intensity and duration with the other groups. The training program included stretching and weight bearing of the affected UE, improving the range of motion of the affected UE, muscle strengthening, and the practice of tasks used for functional training might involve the unaffected UE to assist in the affected UE; for example, stabilizing a bottle while opening its lid or moving pegs into holes on a board.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kwei-shan, Toayuan county

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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