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

• Sponsor: Changhua Christian Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01817816
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Duration (Months): 76.9
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Spasticity	Procedure: Botox_A; Procedure: Botox_B	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botox_A receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)	Procedure: Botox_A
Placebo Comparator: placebo_A receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month.	Procedure: Botox_A
Experimental: Botox_B receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.	Procedure: Botox_B
Placebo Comparator: placebo_B receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month.	Procedure: Botox_B

Outcome Measures

Primary Outcome Measures

1. Change in the muscle tone in upper and lower extremity [4 weeks after injection]

   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

1. Change in the gait pattern as walking [4 weeks after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhua Christian Hospital	Taiwan	Changhua	Taiwan	500

Sponsors and Collaborators

• Changhua Christian Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ta-Sen Wei,MD, Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor, Changhua Christian Hospital
• ClinicalTrials.gov Identifier: NCT01817816
• Other Study ID Numbers: CCH-061203
• First Posted: Mar 25, 2013
• Last Update Posted: Nov 5, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Stroke; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Nov 5, 2015