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

New York Presbyterian Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke

Treatments: Other: Botox®; Other: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01088230

IRB-0904010371

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Exclusion criteria

• Joint contracture and wrist or forearm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Botox®

Experimental group

Description:

this group will receive an injection of botox in the wrist flexors and forearm pronators

Treatment:

Other: Botox®

Saline

Placebo Comparator group

Description:

This group will receive an injection of saline solution in the same muscle groups as the treatment group (wrist flexors and pronators).

Treatment:

Other: saline solution