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Purpose: The
purpose of study is to test the effectiveness of Constraint Induced (CI) therapy in a
subacute population of people who are less than 9 months post-stroke. The hypothesis is
that two weeks (10 days) of intensive task practice in combination with restricted use of
the less affected limb will significantly increase the amount of use of the affected arm
and hand in the home environment. Stroke is the leading cause of disability among American
adults.
Each year in the U.S., approximately 550,000 people suffer strokes and of those, nearly
400,000 survive with some level of neurological impairment and disability. The cumulative
total of living, stroke-affected Americans is nearly 3 million. Despite the enormity of
these statistics, there have been almost no scientific studies of the effectiveness of
post-stroke rehabilitation interventions. What we learn from this study will help us
understand if and how specific exercise programs affect recovery of arm and hand use after
a stroke. This could be important in making decisions for other people about what kind of
physical rehabilitation to use for recovery after stroke. A new therapeutic approach to
the rehabilitation of movement after stroke, termed constraint-induced (CI) movement
therapy developed by Dr Ed Taub at the University of Alabama is being used with people who
have had a stroke of several years duration. With this movement therapy stroke patients
restrict using the less affected "good" arm in a sling or mitt and conduct
exercise task training with the affected arm "weak" arm for most of the day.
Studies to date have been with small number of people and without a control group. This
current project is a national clinical trial funded by the NIH April 2000- March 2005 to
examine the efficacy of this intervention and the long-term effects on changes in
function. Dr. Steve Wolf, at Emory University is PI for the Clinical Trial. |
Subjects: We
will enroll approximately 20-40 subjects over the age of 18 years, who have sustained a
stroke 12 months prior to enrollment in this clinical trial. They will be randomly
assigned to a control or an exercise group. Subjects must to able to travel to our
facilities for testing, training, and follow-up visits, which will require participation
for 2 years (experimental subjects) or 3 years (control subjects).
Eligibility criteria include:
· Subjects who are within 9 months post stroke will be eligible
· Subjects must be over the age of 18 yrs
· Minimum motor criteria: be able to actively extend the involved (side most affected by
the stroke) wrist 10 degrees and extend the thumb and at least 2 additional digits 10
degrees. The subject must be able to complete these movements at least 3 times in 2
minutes.
· Subjects must be able to transfer independently and safely to and from the toilet,
stand from a sitting position and maintain standing balance for 2 minutes with or without
upper limb support.Exclusion criteria include:
· A score below 20 on the Mini-mental exam (MMSE).
· Subjects concurrently participating in any experimental drug study.
· Subjects scoring greater than an average of 2.5 on the Motor Activity Log (MAL).
· Subjects who are concurrently participating in any formal physical rehabilitation
program or clinical trials.
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Length/duration of
participant involvement:
· Participant undergoes testing of arm function followed by a special two-week training
program lasting six hours Monday through Friday.
· Follow-up examinations occur every four months for two years.
Description of the Training:
Subjects will be in the training lab for 6 hr/day daily and supervised by project
personnel for the 10-day intervention. During those 6 hrs, they will wear a Mitt on the
less affected hand a majority of the time. They will remove the Mitt during toileting and
at other agreed upon times for stretching or when safety may be compromised (e.g., during
walking). The subject will practice performing tasks at several stations arranged around
the lab including but not limited to home/office activities (e.g., filing; using rolodex);
grocery/shopping (e.g., putting/retrieving cans on shelf); gardening (e.g., planting and
watering); food preparation (e.g., setting table); home maintenance (e.g., screwing in
light bulb); laundry (e.g., folding towels); cleaning; games/hobbies; and dining/meals
(e.g., eating lunch). Several rest periods will be interspersed throughout the day as
needed. During the lunch hour, the subject will eat the lunch meal that they brought with
them with the Mitt on as part of task practice. Meals are an important part of the
treatment time and patients are encouraged to bring a lunch that they think they can
manage.
Subjects will be tested before and after the training every 4 months for 2 years
following.
People in the control group will receive the training after one year and be followed for 2
years.
Location:
University of North Carolina at Chapel Hill
Benefits to qualifying participants:
Free examinations and tests of arm function
Free two-week special training program
For more information Contact:
Carol Giuliani, PhD
Phone: (919) 966-9796
Fax: (919) 966-3678
Email: carol_giuliani@med.unc.edu
Investigators: Dr. Michael Lee, Department of Physical Medicine and Rehabilitation
Dr. David Good, Bowman Gray-Baptist Hospital Medical Center
Karen McCulloch, MS, NCS, Division of Physical Therapy UNC-CH
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