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

Completed

Phase 1/2 Results N/A

Trial Description

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®.

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.

Conditions

Interventions

  • Botox® Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Botox®
    Description: this group will receive an injection of botox in the wrist flexors and forearm pronators
  • Saline solution Other
    Other Names: salt water
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Saline
    Description: This group will receive an injection of saline solution in the same muscle groups as the treatment group (wrist flexors and pronators).

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change scores on Fugl Meyer- Upper Extremity Section at baseline and discharge No
Secondary Change on kinematic analysis before injection and one week post injection No

Sponsors