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

This study has been completed.
Sponsor:
Information provided by:
New York Presbyterian Hospital
ClinicalTrials.gov Identifier:
NCT01088230
First received: March 11, 2010
Last updated: April 22, 2011
Last verified: November 2010
  Purpose

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 Intervention Phase
Stroke
Other: Botox®
Other: saline solution
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York Presbyterian Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: June 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088230

Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Michael O'Dell, Weill Cornell Medical College/ NewYork Presybterian Hospital
ClinicalTrials.gov Identifier: NCT01088230     History of Changes
Other Study ID Numbers: IRB-0904010371
Study First Received: March 11, 2010
Last Updated: April 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:
hemiparesis
robotics
stroke
Botox®
rehabilitation
wrist spasticity

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014