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

NCT01088230 | Completed Phase 1

• 1 other identifier: IRB-0904010371
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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®.

Conditions

Stroke

Keywords

hemiparesis; robotics; stroke; Botox®; rehabilitation; wrist spasticity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change on kinematic analysis

  before injection and one week post injection

Study Arms (2)

Botox®

EXPERIMENTAL

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

Other: Botox®

Saline

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: botulinum toxin serotype-A

Botox®

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.

Also known as: salt water

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Joint contracture and wrist or forearm

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Sites (1)

New York Presbyterian Hospital- Weill Cornell campus

New York, New York, 10065, United States

Location

Related 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.

  PMID: 19407231 BACKGROUND

• 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.

  PMID: 18617860 BACKGROUND

• 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.

  PMID: 19841830 BACKGROUND

• 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. doi: 10.1097/PHM.0b013e31813e2b4d.

  PMID: 17709993 BACKGROUND

Related Links

• click here for to sign up for future stroke studies at NYPH

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Botulinum Toxins, Type A; Saline Solution; Fluoridation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 17, 2010
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 26, 2011

Record last verified: 2010-11

Locations

US (1)