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Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

Primary Purpose

Cerebrovascular Accidents

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EP
CIT
conventional therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accidents focused on measuring stroke rehabilitation, perceptual deficits, kinematic analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CIT with eye-patching

constraint-induced therapy

conventional therapy

Arm Description

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. Participants were also 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.

The intervention in this group resembled the intervention of the CIT+EP group, except participants did not wear the EP glasses.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical measures at the impairment, activity, participation levels
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.
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.

Full Information

First Posted
October 30, 2008
Last Updated
August 26, 2012
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00784706
Brief Title
Effect of Combined Therapy on Neglect Syndrome in Stroke Patients
Official Title
Effect of Combined Therapy on Neglect Syndrome in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accidents
Keywords
stroke rehabilitation, perceptual deficits, kinematic analysis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CIT with eye-patching
Arm Type
Experimental
Arm Description
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. Participants were also 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.
Arm Title
constraint-induced therapy
Arm Type
Experimental
Arm Description
The intervention in this group resembled the intervention of the CIT+EP group, except participants did not wear the EP glasses.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EP
Other Intervention Name(s)
eye-patching therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CIT
Other Intervention Name(s)
constraint-induced therapy(CIT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Catherine Bergego Scale (CBS)
Description
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.
Time Frame
2008-2009
Secondary Outcome Measure Information:
Title
Clinical measures at the impairment, activity, participation levels
Time Frame
2008-2009
Title
Eye movement analysis
Description
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.
Time Frame
2008-2009
Title
kinematic variables
Description
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.
Time Frame
2008-2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Department of Occupational Therapy, Chang Gung Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-shan, Toayuan county
Country
Taiwan

12. IPD Sharing Statement

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Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

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