Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2011

Conditions
Stroke
Interventions
DRUG

Botox and rehab

Patients will BOTOX® (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.

DRUG

Placebo and rehab

Patients will receive placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.

Trial Locations (1)

30322

Emory University, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Emory University

OTHER