Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis
Stopped early · Not applicable
Conditions studied: Muscle Spasticity
In brief
A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will randomly be selected to participate in either unilateral (one-handed) task training (6 participants) or bilateral (two-handed) task training (6 participants) with the SaeboFlex orthosis. Each group will undergo six assessments to establish pre-testing baseline and qualification, followed by a training session, four-week combined home and clinic program, and post-testing to determine changes in affected arm use and function. The hypothesis is that two-handed training will before effective than one-handed training.
Key facts
- Study ID
- NCT00893776
- Run by
- University of Missouri-Columbia
- People needed
- 9
- Starts
- 2009-06-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-10-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- at least 18 years of age
- >6 months post stroke
- diagnosis of first stroke
- medically stable
- ability to follow multipart verbal directions
- score of >26 on Mini-Mental Status Exam
- achieve 10 degrees elbow flexion
- 1/4 range volitional finger flexion when hand positioned in wrist and finger extension
- capable of standing for >2 minutes without an assistive ambulatory device
- maintain independence in self-care or have a caretaker to provide assistance
- no concurrent skilled therapy treatment
- not participating in any experimental rehabilitation or drug studies.
You may not qualify if…
- more than one stroke/multiple strokes
- receptive aphasia
- medically documented dementia
- score less than 26 on Mini Mental Status Exam
- contractures or joint deformities in the affected hand or wrist that impede the ability to use the device
- inability to transfer 12 balls crate right and 12 balls crate left, while using the Saeboflex device on the affected arm, by the end of a 5-day training session.
Where it is running
- University of Missouri, Lewis and Clark Hall — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.