Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02557737
Study type Interventional
Source Chang Gung Memorial Hospital
Contact Pong Ya-Ping, MD
Phone 889-7-7317123
Email yaping0707@gmail.com
Status Recruiting
Phase Phase 3
Start date September 2012
Completion date July 2016

See also
  Status Clinical Trial Phase
Completed NCT05477238 - Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls N/A
Completed NCT00046293 - ReoPro and Retavase to Treat Acute Stroke Phase 2
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT01116544 - Treatment of Chronic Stroke With AMES + EMG Biofeedback N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Active, not recruiting NCT02563886 - Electrically Assisted Movement Therapy N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT02141932 - Pocket-size Cardiovascular Ultrasound in Stroke N/A
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Recruiting NCT01769326 - Influence of Timing on Motor Learning N/A
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Completed NCT01656876 - The Effects of Mirror Therapy on Upper Extremity in Stroke Patients N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT01423201 - Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
Withdrawn NCT00573092 - Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs N/A
Completed NCT00542256 - tDCS and Physical Therapy in Stroke N/A
Completed NCT00377689 - Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke Phase 2
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Terminated NCT00120289 - Niacin Plus Statin to Prevent Vascular Events Phase 3
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study