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

NCT01817816 | Completed

• 1 other identifier: CCH-061203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity

Outcome Measures

Primary Outcomes (1)

• Change in the muscle tone in upper and lower extremity

  use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal 1. slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (\<1/2) 2. moderate hypertonus,, limbs moves easily (\>1/2) 3. passive movement difficult 4. rigid

  4 weeks after injection

Secondary Outcomes (1)

• Change in the gait pattern as walking

  4 weeks after intervention

Study Arms (4)

Botox_A

EXPERIMENTAL

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

Procedure: Botox_A

placebo_A

PLACEBO COMPARATOR

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

Procedure: Botox_A

Botox_B

EXPERIMENTAL

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

Procedure: Botox_B

placebo_B

PLACEBO COMPARATOR

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

Procedure: Botox_B

Interventions

Botox_A PROCEDURE

Botox_A; placebo_A

Botox_B PROCEDURE

Botox_B; placebo_B

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• recurrent stroke, cognition impaired
• lower limb fracture
• received anti-spasticity injection in the past

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Dawan, Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: January 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

TW (1)