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

Sponsor

New York Presbyterian Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01088230

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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 Names: 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 Names: salt water

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 Names:

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 Names:

salt water

Outcome Measures

Primary Outcome Measures

Change scores on Fugl Meyer- Upper Extremity Section [at baseline and discharge]
The Fugl Meyer assess quality of movement of the limb at an impairment level.

Secondary Outcome Measures

Change on kinematic analysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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