IRBMED NO: HUM00000277
IRBMED Project Approval Expires On: 11/15/2007
Upper Limb Sensorimotor Training in Adults
With Hemiplegic Cerebral Palsy
(Project ULTrA)
What is the purpose of this research study?
The objective of this proposal is to gain more information regarding task-specific sensorimotor training program (ULTrA Program) on upper limb function in individuals with CP. We hope to find out whether a home-based upper limb training program will lead to improved arm and hand sensory and motor function in adults with hemiplegic cerebral palsy.
Who can take part in this study?
Twenty adults ages 18 to 50 who have difficulty with movement of one arm and are diagnosed with hemiplegic cerebral palsy.
Why should I consider joining this study as a research participant?
This study will provide information about how adults with these problems use their hands. This is especially critical in that we will be studying task based rehabilitation training across the lifespan. The majority of research conducted currently focuses on the pediatric participants thus no information as these participants age. This information will hopefully lead to further studies that will investigate new treatments for these problems.
Do I have to become a participant in this study? If I joined the study, can I change my mind and drop out before it ends?
Becoming a participant in this study is entirely by your own free choice. You may also drop out of the study by your own free will, after having agreed to become a subject. You may refuse to enroll in the study, or drop out of the study at any time without any penalty; by doing so you will not lose any benefits that you may be entitled to.
What exactly will be done to me, and what kinds of treatments or procedures will I receive, if I agree to be a research subject in this study?
Prior to and following the intervention, our research staff will perform a series of tasks that involve movement of the arm and hand. These tasks will include reaching, grasping, and other similar tasks. We will attach wires to the participant's arm, and record information about the movements by computer. The testing will likely take less than two hours to complete. Participants will receive individualized training as well as written instructions for the task specific intervention training protocol (ULTrA Program). Participants will be instructed to practice a series of repetitive movements (see below) five times per week. Each training session will last approximately 40 min. All ULTrA tasks will be performed from a seated position in front of a table. A series of tasks involving the upper limb and hand including reaching, grasping, and stretching, will be performed during each training session. Initial arm and hand position for some of the tasks may vary slightly depending upon ROM and/or spasticity.
What will the investigators do to make sure that the information they will collect on me will not get in wrong hands?
We shall put the information collected about you during the study into a research record. This research record will not show your name, but will have codes entered into it, that will allow the information to be linked to you. However, we shall keep your research record confidential, to the extent provided by federal, state and local law. We shall not allow anyone to see your record, other than people who have a right to see it. You will not be identified in any reports on this study.
What kinds of benefit can I expect personally from taking part in this study?
Participants will receive $90 to cover time and expenses for the two pre-tests and one post-test. In addition, participants will receive $200 for participating in the intervention protocol (Project ULTrA).
Inclusion Criteria
- Adults between the ages of 18-50 with hemiplegic cerebral palsy
- Independent community dwellers
- Cognitive and English language skills to understand training program
- Adequate range of motion and muscle strength to perform reaching movements
- Adequate ability to partially open and close the affected hand
- Willingness to participate in a ten week training program
Exclusion Criteria
- Muscle transfer surgery of the upper limb
- Botulinum toxin injections (within the last six months)
- Additional neuromuscular or musculoskeletal conditions (arthritis or contractures)
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