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Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis

This study has been terminated.
(Insufficient time for study extenuating personal circumstances of PI)
Sponsor:
Information provided by (Responsible Party):
Giuli Krug, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00893776
First received: May 4, 2009
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Muscle Spasticity
Other: Task Training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis in Individuals With Subacute and Chronic Stroke.

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Wolf Motor Function Test (WMFT) [ Time Frame: Before and immediately after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Canadian Occupational Performance Measure [ Time Frame: Before and immediately after intervention ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: June 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Unilateral Group
This group will wear the SaeboFlex orthosis on their affected extremity and do exercises with that extremity only. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns)
Other: Task Training
Task training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity.
Experimental: 2 Bilateral training
Members of this group will wear the SaeboFlex orthosis on the affected extremity and do exercises with the affected extremity and the non-affected extremity at the same time. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns)
Other: Task Training
Task training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893776

Locations
United States, Missouri
University of Missouri, Lewis and Clark Hall
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Giulianne Krug, MA, OTR/L University of Missouri, Occupational Therapy and Occupational Science
  More Information

Additional Information:
Responsible Party: Giuli Krug, Clinical Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00893776     History of Changes
Other Study ID Numbers: 1134397 
Study First Received: May 4, 2009
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 28, 2016