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

Stroke Clinical Trial

Official title:

The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke: A Double Blind, Placebo-Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088230
• Other study ID #: IRB-0904010371
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2010
• Last updated: April 22, 2011
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital- Weill Cornell campus	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of upper limb botulinum toxin injections on impairment, activity, participation, and quality of life among stroke patients. Stroke. 2009 Jul;40(7):2589-91. doi: 10.1161/STROKEAHA.108.544346. Epub 2009 Apr 30. — View Citation

Fasoli SE, Fragala-Pinkham M, Hughes R, Krebs HI, Hogan N, Stein J. Robotic therapy and botulinum toxin type A: a novel intervention approach for cerebral palsy. Am J Phys Med Rehabil. 2008 Dec;87(12):1022-5. doi: 10.1097/PHM.0b013e31817fb346. — View Citation

Frascarelli F, Masia L, Di Rosa G, Petrarca M, Cappa P, Castelli E. Robot-mediated and clinical scales evaluation after upper limb botulinum toxin type A injection in children with hemiplegia. J Rehabil Med. 2009 Nov;41(12):988-94. doi: 10.2340/16501977-0412. — View Citation

Levy CE, Giuffrida C, Richards L, Wu S, Davis S, Nadeau SE. Botulinum toxin a, evidence-based exercise therapy, and constraint-induced movement therapy for upper-limb hemiparesis attributable to stroke: a preliminary study. Am J Phys Med Rehabil. 2007 Sep;86(9):696-706. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores on Fugl Meyer- Upper Extremity Section	The Fugl Meyer assess quality of movement of the limb at an impairment level.	at baseline and discharge	No
Secondary	Change on kinematic analysis	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.	before injection and one week post injection	No

External Links

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