Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

NCT00784706 | Completed

• 1 other identifier: 97-1391B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accidents

Keywords

stroke rehabilitation; perceptual deficits; kinematic analysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Clinical measures at the impairment, activity, participation levels

  2008-2009

• Eye movement analysis

  2008-2009

• kinematic variables

  2008-2009

Study Arms (3)

CIT with eye-patching

EXPERIMENTAL

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.

Other: EP; Other: CIT

constraint-induced therapy

EXPERIMENTAL

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

Other: CIT

conventional therapy

ACTIVE COMPARATOR

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.

Other: conventional therapy

Interventions

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.

Also known as: eye-patching therapy

CIT with eye-patching

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.

Also known as: constraint-induced therapy(CIT)

CIT with eye-patching; constraint-induced therapy

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.

conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

serum P-component; Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Ching-yi Wu, ScD

  Department of Occupational Therapy, Chang Gung Univ.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 4, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 28, 2012

Record last verified: 2012-07

Locations

TW (1)