Why is this study being done?

This study is about arm and hand recovery after a stroke. We are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant’s choice compared to two standard types of therapy (occupational therapy totaling 30 hours and occupational therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient occupational therapy (OT dosage, content) for individuals who are eligible for ICARE.

Who may be eligible to participate?

A total of 360 individuals from multiple sites within three Centers (Atlanta GA, Los Angeles, CA, Washington DC) who:

• sustained a stroke within the last 3 months, with resultant weakness in one arm/hand
• are at least 21 years old,
• could attend outpatient therapy 3x/week for 10-16 weeks
• could attend periodic follow-up evaluations up to 1 year afterwards
• have no other medical conditions that affect their movement
• do not have dementia or pre-existing cognitive deficits

What is involved in the study?

All participants, regardless of study group will receive comprehensive evaluations up to 1-year and will receive therapy in the outpatient setting provided by licensed/certified occupational therapists (OT), and physical therapists (PT). In addition, study participants are not precluded from receiving additionally prescribed outpatient therapies including physical therapy, speech therapy, or other services.
All enrolled participants will be randomly assigned to one of three study groups that will vary by therapy focus/content and dosage. They are:

• The investigational intervention, Accelerated Skill Acquisition Program (ASAP):
  30 visits of an individualized therapy focused on the arm most affected by the stroke. This is an integrated and evidence-based intervention for upper extremity recovery that arose from diverse but converging and complementary and interdisciplinary literatures of basic and applied science as well as recent translational and clinical trials research of upper extremity recovery after stroke. Unique aspects include the structured framework by which intensity and progression of practice is managed and by which participant skills and confidence are fostered through therapist-patient dialogue.
• A dose-equivalent (30 visits) of usual and customary occupational therapy (DEUCC): 30 visits scheduled 3x/week over 10 – 16 weeks.
• Usual and customary occupational therapy care (UCC): delivered at the dosage common for that outpatient setting.

What do these interventions involve?

Accelerated Skill Acquisition Program (ASAP):
Participants randomized to ASAP will be given a customized package of therapy that includes challenging, intensive, and meaningful practice of participant chosen real-world tasks (e.g., carrying groceries, handwriting) that engage the arm most affected by the stroke. Participants will be offered a mitt to wear on their stronger arm during their time outside of therapy to promote use of the weaker arm; however, they will not be required to use the mitt if they so choose. Outside of therapy specific assignments (Action Plans) will be given to encourage self-managed, confident, safe, and effective arm use at home and in the community. Therapy sessions will be 1 hour in length and be scheduled 3x/week over 10 – 16 weeks. To prevent cross-contamination between study groups further details of the investigational intervention have been embargoed until after study completion.

Usual and Customary Occupational Therapy:
Participants assigned to one of the following other two study groups (DEUCC, UCC) will receive OT as it is typically practiced in the outpatient clinic. The scope of typical OT for patients with stroke may be more comprehensive than the focused package defined as ASAP. It may address issues or use interventions directed at other than the arm most affected by the stroke, including: perceptual deficits, splint and equipment fabrication, modalities (e.g., ice, heat), exercise, activities of daily living training, and vocation-related rehabilitation.

How do I refer my patient for consideration in the ICARE study?

If you believe you have an eligible patient, please contact:

Clinical site coordinator/lead physician:
Sarah Blanton, PT, DPT, NCS – Clinical Site Coordinator
David Burke, MD – Emory physician
Steven Wolf, PhD, PT, FAPTA – Emory site Principal Investigator

Contact information:
Sarah Blanton, PT, DPT, NCS
Sarah.Blanton@emory.edu
(404) 712-2222
(404) 712-5973 (FAX)