Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The present study is designed to determine the safety and effectiveness of injections of
      BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would
      do nothing) when combined with rehabilitation therapy for the improvement of active function
      tasks in post-stroke patients. Injections will be targeted to reduce common spasticity
      patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist,
      thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory
      University. Neither the doctor injecting the drug nor the subject receiving the drug will
      know if they are getting BOTOX® or saline. Which type of injection the subject receives will
      be completely randomized (like flipping a coin). All subjects will have rehabilitation
      therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits
      (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects
      will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5
      times a week, for 4 weeks. The results from this project will provide valuable data on the
      ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic
      muscles of the arm and hand after stroke. This project has the potential to increase the
      availability of effective rehabilitation techniques to patients with stroke.
    

Detailed description: 
      After a stroke, patients commonly experience tightness in their affected arm from wrist and
      hand muscle overactivity called spasticity. Spasticity is difficult to manage with only one
      type of treatment. Usual treatments of spasticity are not very effective and may produce
      unwanted side effects. Untreated spasticity may result in muscular problems and decrease a
      patient's general ability to function and thus affect his/her quality of life.

      BOTOX®, a botulinum toxin type A produced from Clostridium botulinum, blocks certain
      chemicals that cause spasticity. With appropriate injections of BOTOX® in the correct muscle,
      it can change the tightness in the muscle temporarily. Published reports indicate that
      several hundred adult patients with arm and/or leg spasticity of various causes (e.g.,
      poststroke, multiple sclerosis and traumatic brain injury) have benefited from injections of
      BOTOX® in the spastic muscle. The efficacy of BOTOX® in patients with post-stroke spasticity
      in their arms and hands has been demonstrated in seven phase 2 placebo-controlled studies and
      two phase 3 studies.

      The present study is designed to determine the safety and effectiveness of injections of
      BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would
      do nothing) when combined with rehabilitation therapy for the improvement of active function
      tasks in post-stroke patients. Injections will be targeted to reduce common spasticity
      patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist,
      thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory
      University. Neither the doctor injecting the drug nor the subject receiving the drug will
      know if they are getting BOTOX® or saline. Which type of injection the subject receives will
      be completely randomized (like flipping a coin). All subjects will have rehabilitation
      therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits
      (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects
      will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5
      times a week, for 4 weeks. The results from this project will provide valuable data on the
      ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic
      muscles of the arm and hand after stroke. This project has the potential to increase the
      availability of effective rehabilitation techniques to patients with stroke.
    

Intervention name(s): Botox and rehab; Placebo and rehab
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke, Cerebrovascular accident, Spasticity, Arm, Hand