Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2017 |
| Start Date: | June 2009 |
| End Date: | December 2014 |
The Effectiveness of Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis in Individuals With Subacute and Chronic Stroke.
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.
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.
The SaeboFlex device is a mechanical orthosis that promotes grasp and release and functional
movement of an upper limb that has impaired movement due to a stroke. Many researchers have
found that incorporating both the affected and unaffected limb together during exercises
(bilateral task training) results in increased functional use of the affected limb as
compared to only performing exercises with the affected limb. Therefore, we want to determine
if bilateral task training is more effective than unilateral task training with the use of
the SaeboFlex device in subacute and chronic stroke rehabilitation. For the unilateral
training group, exercises will be completed with only the affected hand using the Saebo
device. For the bilateral group, the Saebo will be on the affected hand, no device on the
unaffected hand, and both arms will do the exact same movements/exercises at the same time.
The participants will be videotaped and photographed moving balls without the device, with
the device at the start of the study, with the device midway through the study, and at the
end of the study. This will be done for the purpose of providing participant feedback
regarding their progress and for report of outcomes upon completion of the project. Faces
will be omitted from all photographic media at the request of the participant, and the
participant may decline photographic media at any time without having to withdraw from the
study.
movement of an upper limb that has impaired movement due to a stroke. Many researchers have
found that incorporating both the affected and unaffected limb together during exercises
(bilateral task training) results in increased functional use of the affected limb as
compared to only performing exercises with the affected limb. Therefore, we want to determine
if bilateral task training is more effective than unilateral task training with the use of
the SaeboFlex device in subacute and chronic stroke rehabilitation. For the unilateral
training group, exercises will be completed with only the affected hand using the Saebo
device. For the bilateral group, the Saebo will be on the affected hand, no device on the
unaffected hand, and both arms will do the exact same movements/exercises at the same time.
The participants will be videotaped and photographed moving balls without the device, with
the device at the start of the study, with the device midway through the study, and at the
end of the study. This will be done for the purpose of providing participant feedback
regarding their progress and for report of outcomes upon completion of the project. Faces
will be omitted from all photographic media at the request of the participant, and the
participant may decline photographic media at any time without having to withdraw from the
study.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
