Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

NCT ID: NCT00784706

Last Updated: 2012-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-10-31

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.

Conditions

Cerebrovascular Accidents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CIT with eye-patching

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.

Group Type: EXPERIMENTAL

EP

Intervention Type: 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.

CIT

Intervention Type: 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.

constraint-induced therapy

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

Group Type: EXPERIMENTAL

CIT

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

eye-patching therapy; constraint-induced therapy(CIT)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy, Chang Gung Univ.

Locations

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, , Taiwan

Countries

Taiwan

Other Identifiers

97-1391B

Identifier Type: -

Identifier Source: org_study_id