ICARE Study
Who may be eligible to participate?
Recruitment is open for individuals who:
- sustained a stroke within the last 106 days
- have Hemiparesis (weakness) in the arm/hand affected by the stroke
- are at least 21 years old
- are able to attend outpatient therapy 1 hour/day 3 days/week for 10 weeks
- are able to attend (4) evaluations up to 1 year after randomization
- have no other medical conditions that affect movement (e.g. Parkinson's, ALS, MS)
- do not have a recent history of drug or alcohol abuse
- do not have dementia or pre-existing cognitive deficits
If I enroll in ICARE can I have other therapy?
Yes. Study participants are not precluded from receiving additionally prescribed therapies including physical therapy, speech therapy, or other services.
What is the informed consent?
Informed consent is a process in which you learn more about the important facts related to a clinical trial in order for you to make an informed decision about whether or not to participate. During the informed consent process you should learn more about the procedures for the evaluations and treatment of the clinical trial, the known benefits, the known risks, alternative treatments, confidentiality of records, compensation, and the ability to withdraw at any time without penalty. During this time, you should also feelfree to ask any questions you may have about the study in which you may be participating.
How are participants protected?
Clinical trials within the U.S. must be approved and monitored by an Institutional Review Board (IRB). The IRB is an independent committee of physicians, statisticians, community advocates, and others. They are responsible for ensuring that the risks are as low as possible and out-weighed by potential benefits, and that the clinical trial is ethical. They are also responsible for verifying that the rights of the participant are protected.
Can a participant leave a clinical trial after it has begun?
Yes. As a participant, you have the right to withdraw from a clinical trial at any time. However, it¹s important for the research staff to know that you are leaving the study and why.
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 3 x/week over 10 weeks. To prevent cross-contamination between study groups further details of the investigational intervention have been embargoed until after study completion.
Usual and Customary Outpatient Arm Therapy:
Participants assigned to one of the following other two study groups (DEUCC, UCC) will receive traditional outpatient arm therapy as it is typically practiced in the outpatient clinic. The scope of typical therapy 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.
Who do I contact for consideration in the ICARE study?
If you believe you are or you know an eligible participant, please contact:
Monica A. Nelsen, PT, DPT
ICARE Clinical Project Manager, Clinical Research Faculty
Division of Biokinesiology & Physical Therapy
University of Southern California
1540 Alcazar Street, CHP 155
Los Angeles, CA 90033
Tel: (323) 224-7081
Fax: (323) 224-5001
nelsen@usc.edu