Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

NCT ID: NCT01817816

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-06-30

Brief Summary

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Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.

This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

Detailed Description

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Conditions

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Stroke Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botox_A

receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)

Group Type EXPERIMENTAL

Botox_A

Intervention Type PROCEDURE

placebo_A

receiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month.

Group Type PLACEBO_COMPARATOR

Botox_A

Intervention Type PROCEDURE

Botox_B

receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.

Group Type EXPERIMENTAL

Botox_B

Intervention Type PROCEDURE

placebo_B

receiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month.

Group Type PLACEBO_COMPARATOR

Botox_B

Intervention Type PROCEDURE

Interventions

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Botox_A

Intervention Type PROCEDURE

Botox_B

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* first-ever stroke, with spasticity within 3-months (MAS=2\~3)
* independent walking 10 meters (with assistive devices)

Exclusion Criteria

* recurrent stroke, cognition impaired
* lower limb fracture
* received anti-spasticity injection in the past
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhua Christian Hospital

Dawan, Changhua, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CCH-061203

Identifier Type: -

Identifier Source: org_study_id

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