The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088230
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : April 26, 2011
Information provided by:
New York Presbyterian Hospital

Brief Summary:
The purpose of this study is to see whether treating subjects for wrist rehabilitation following stroke with Botox® and robotic therapy is more effective than treatment with robotic therapy alone and no Botox®.

Condition or disease Intervention/treatment Phase
Stroke Other: Botox® Other: saline solution Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Rehabilitation

Arm Intervention/treatment
Experimental: Botox®
this group will receive an injection of botox in the wrist flexors and forearm pronators
Other: Botox®
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

Primary Outcome Measures :
  1. Change scores on Fugl Meyer- Upper Extremity Section [ Time Frame: at baseline and discharge ]
    The Fugl Meyer assess quality of movement of the limb at an impairment level.

Secondary Outcome Measures :
  1. Change on kinematic analysis [ Time Frame: before injection and one week post injection ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 6 months post-stroke
  • Single stroke
  • Ashworth Scale of > 2 but < 4 for wrist flexors and pronators
  • Able to follow multiple step directions
  • Completed all active occupational therapy
  • Motor strength > 1/5 at the wrist extension and supination
  • Passive ROM of 0-45 degrees at wrist flexion and extension, 0-20 degrees at radial deviation, 0-20 degrees at ulnar deviation, 0-45 degrees at pronation and supination
  • No Botox® injection in the wrist/forearm muscles for at least 12 months
  • Naïve to robotics study protocol

Exclusion Criteria:

  • Joint contracture and wrist or forearm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088230

United States, New York
New York Presbyterian Hospital- Weill Cornell campus
New York, New York, United States, 10065
Sponsors and Collaborators
New York Presbyterian Hospital

Additional Information:
Responsible Party: Michael O'Dell, Weill Cornell Medical College/ NewYork Presybterian Hospital Identifier: NCT01088230     History of Changes
Other Study ID Numbers: IRB-0904010371
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: November 2010

Keywords provided by New York Presbyterian Hospital:
wrist spasticity

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents