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Completed

NCT Number: NCT00784706

Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EP

Other

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.

Other names: eye-patching therapy

CIT

Other

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.

Other names: constraint-induced therapy(CIT)

Conventional Therapy

Other

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 outcomes

  1. Catherine Bergego Scale (CBS)

    Time frame: 2008-2009

    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 outcomes

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

    Time frame: 2008-2009

  2. Eye movement analysis

    Time frame: 2008-2009

    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.

  3. kinematic variables

    Time frame: 2008-2009

    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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan
  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2008
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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