Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

Phase 3

• Conditions: Cerebrovascular Accident
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT02557737
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.

Detailed Description

Stroke may result in acute or chronic hemiplegia and spasticity in stroke patients. Spasticity in upper extremities may interfere with motor voluntary function, activities of daily living and cause muscle pain. Botulinum toxin type A (BTX-A) has been shown to relieve spasticity and pain in upper extremities of stroke patients. There are no researches to compare the efficiency of BTX-A by different injection guidance methods in stroke patients. The aims of our study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness. The investigators will enroll 60 hemiplegic stroke patients with upper extremity spasticity more than modified Ashworth scale ( MAS) 1+ and duration more than 6 months. Under different guidance methods (surface anatomy landmark/ ultrasonography /electric stimulation ), BTX-A will be injected to the key spastic muscles on upper extremity. Outcome measures include MAS, motor function ( Brunnstrom stage of upper extremity), range of motion , the degree and visual analog scale of pain , pinch and grasp power，Stroke Impact Scale, Barthel index and upper extremity function (Nine hole peg test，Action Reaearch Arm Test，Wolf Motor Function test，Chedoke Arm and Han Activity Inventory，Fugl-Meyer Assessment Scale，Motor Activity Log). All the assessments will be performed before BTX-A injection and followed up at 4 weeks, 8 weeks, 12 weeks and 24 weeks after injection. After performing all the assessments, investigators will investigate the efficiency of BTX-A by different guidance methods.

Four of arms:

ultrasonography direct-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.

ultrasonography indirect-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography indirect-guidance.

electric stimulation guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by electric stimulation guidance.

surface anatomy landmark: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by surface anatomy landmark.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-30
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• first onset.
• at least onset before 6 months.
• elbow, wrist and fingers are above Modified Ashworth Scale(MAS) 1+.
• Mini-Mental State Exam above 24.
• can follow all of the follow up and instruction.
• patients never accept botox, phenol and alcohol injections before.

Exclusion Criteria

• contracture deformity on upper extremity.
• patients had accepted botox before or had have phenol, alcohol injections and operation 6 months ago.
• allergy to botox.
• have neither infection nor skin disorder on inject site.
• now accept aminoglycoside or other medicine treatment which may affect neuromuscular transition.
• combine other systemic disease of neurological or skelectomuscular system
• cognition disorder or aphasia after stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric stimulation	Botulinum Toxin Type A	To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation
Ultrasonography direct-guidance	Botulinum Toxin Type A	To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
Surface anatomy landmark	Botulinum Toxin Type A	To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	Change from Baseline Muscle Tone at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection

Secondary Outcome Measures

Name	Time	Method
Pinch Strength Assessment	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Brunnstrome Stage	Change from Baseline Condition at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Active Range of Motion	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
4 Point Categorical Pain Intensity Scale	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Hand-grasp strength Assessment	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Barthel Index	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Stroke Impact Scale (SIS)	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Action Research Arm Test (ARAT)	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Wolf Motor Function Test	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Chedoke Arm and Hand Activity Inventory (CAHAI)	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Fugl-Meyer Assessment	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Motor Activity Log Scale	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Nine Hole Peg Test	Change from Baseline Data at 6 months	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan