The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke: A Double Blind, Placebo-Controlled Pilot Study|
- Change scores on Fugl Meyer- Upper Extremity Section [ Time Frame: at baseline and discharge ] [ Designated as safety issue: No ]The Fugl Meyer assess quality of movement of the limb at an impairment level.
- Change on kinematic analysis [ Time Frame: before injection and one week post injection ] [ Designated as safety issue: No ]Kinematic information is recorded during administration of the assessment mode of the InMotion 3 wrist robotic device. Movements of the wrist (flexion,extension,ulnar/radial deviation) and forearm (pronation, supination)are recorded for subsequent analysis. Kinematic parameters such as smoothness, position and velocity of movement are examined pre and post injection. The information is extracted from the robotics device and analyzed via computer programs.
|Study Start Date:||June 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
this group will receive an injection of botox in the wrist flexors and forearm pronators
the treatment group will receive a one time injection of Botox® at the wrist flexors and pronators of the affected arm. Each subject will receive a standard dose of 150 units total, 50u each to the flexor carpi radialis and flexor carpi ulnaris, and 25u each for the pronator teres and pronator quadratus muscle groups.
Other Name: botulinum toxin serotype-A
Placebo Comparator: Saline
This group will receive an injection of saline solution in the same muscle groups as the treatment group (wrist flexors and pronators).
Other: saline solution
the control group will receive a one time injection of salt water in the flexor carpi radialis and flexor carpi ulnaris, and the pronator teres and pronator quadratus muscle groups.
Other Name: salt water
This study will explore new ways to facilitate rehabilitation of wrist function after stroke. One of the challenges of recovery is muscle stiffness or excessive muscle tone that often limits exercise or therapy progress. Taking this into account, the investigators propose treating the wrist and forearm with a combination of a one-time Botox® injection and a 6-week robotic therapy protocol to maximize recovery.
Botox® is a drug that is injected directly into a muscle to temporarily relax the muscle. Botox® is commonly used to decrease muscle tone in tight muscles in the stroke population. Robotics therapy provides highly repetitive mass practice with visual and haptic feedback.
Subjects will be randomized to two groups. Group A will receive the Botox® injection and group B will receive a placebo saline injection. Both groups will receive the same robotics therapy protocol. Subjects and investigators will be blinded to group assignment. The investigators would like to know if there are trends between groups in a variety of outcome measures depending on what intervention they received. The investigators predict that the treatment group will have better results than the control group on the Fugl Meyer, our primary outcome measure. The investigators hope the results of this pilot study will guide development of a larger clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088230
|United States, New York|
|New York Presbyterian Hospital- Weill Cornell campus|
|New York, New York, United States, 10065|