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

Primary Purpose

Stroke, Spasticity

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Botox_A
Botox_B
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Botox_A

placebo_A

Botox_B

placebo_B

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in the muscle tone in upper and lower extremity
use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2) moderate hypertonus,, limbs moves easily (>1/2) passive movement difficult rigid

Secondary Outcome Measures

Change in the gait pattern as walking

Full Information

First Posted
March 21, 2013
Last Updated
November 3, 2015
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01817816
Brief Title
Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox_A
Arm Type
Experimental
Arm Description
receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
Arm Title
placebo_A
Arm Type
Placebo Comparator
Arm Description
receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month.
Arm Title
Botox_B
Arm Type
Experimental
Arm Description
receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.
Arm Title
placebo_B
Arm Type
Placebo Comparator
Arm Description
receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month.
Intervention Type
Procedure
Intervention Name(s)
Botox_A
Intervention Type
Procedure
Intervention Name(s)
Botox_B
Primary Outcome Measure Information:
Title
Change in the muscle tone in upper and lower extremity
Description
use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2) moderate hypertonus,, limbs moves easily (>1/2) passive movement difficult rigid
Time Frame
4 weeks after injection
Secondary Outcome Measure Information:
Title
Change in the gait pattern as walking
Time Frame
4 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Changhua Christian Hospital
City
Taiwan
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

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

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