Skip to main content
OpenTrials
Completed

NCT Number: NCT01088230

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

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®.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York Presbyterian Hospital- Weill Cornell campus

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox®

Other

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

Saline solution

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York Presbyterian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2010
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.