Assessing Leg Control in People With Chronic Stroke
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|ClinicalTrials.gov Identifier: NCT03271463|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment|
|Chronic Stroke||Behavioral: Selective Control Assessment of Lower Extremity (SCALE)|
Selective voluntary motor control may be important in prognosticating future function in adults post stroke. It is therefore important to measure selective voluntary motor control using assessments that are valid, reliable and easy to perform and interpret. Current assessments are time consuming and complicated. Clinicians who work with patients post stroke will benefit from this research because they will have evidence supporting appropriate measurement of selective voluntary motor control. This evidence may inform their clinical decision making when working with patients. Patients who have survived a stroke will benefit because their therapists will be able to better measure their selective voluntary motor control which may one day lead to better prediction of functional outcomes and the selection of appropriate interventions.
The Fugl-Meyer assessment (FMA) is the "Gold Standard" for the assessment of individuals with brain injury, most commonly those surviving cerebrovascular accident (stroke). The full assessment is complicated and can take more than an hour to complete. Clinicians have limited time to perform a full evaluation of their patients, the FMA is just one part of this evaluation. The lower extremity selective voluntary motor control component of the FMA (FMA-LE) is difficult for clinicians who are not experts to perform and interpret. For these reasons, few practicing clinicians use the FMA. However, measuring selective voluntary motor control may be important for prognosticating patients' future functional level and their need for continued therapeutic interventions. The Selective Control Assessment of Lower Extremity (SCALE) was developed for use with children who have cerebral palsy (CP), a condition that in some ways presents similar to stroke. The SCALE has been validated and deemed reliable in the pediatric population with CP. This study aims to determine inter-rater and intra-rater reliability for the FMA-LE and the SCALE. In addition, scores on the SCALE will be compared to scores on the FMA-LE to determine concurrent validity. Finally the scores on the SCALE and FMA-LE will be compared to the time it takes for stroke survivors to walk 10-meters (10-meter walk test) to determine how well each measure predicts functional status (predictive validity).
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Lower Extremity Selective Voluntary Motor Control in Adults With Chronic Stroke: Comparing the SCALE Assessment to the Fugl-Meyer Assessment|
|Actual Study Start Date :||August 5, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Reliability/Validity of SCALE Assessment
Reliability + validity of the Selective Control Assessment of Lower Extremity (SCALE) in people with chronic stroke.
Behavioral: Selective Control Assessment of Lower Extremity (SCALE)
Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)
- Selective Control Assessment of Lower Extremity (SCALE) [ Time Frame: Baseline to 4 weeks ]Each item is rated 2-0, 2 being Normal and 0 being Unable to Move
- Fugl-Meyer Assessment-Lower Extremity component (FMA-LE) [ Time Frame: Baseline to 4 weeks ]
The complete Fugl-Meyer contains 155 items and each item is rated on a three-point ordinal scale, 2 points for the detail being performed completely, 1 point for the detail being partially completed, and 0 points for the detail not being performed. The maximum score for the motor performance is divided into 66 points for the upper extremity and 34 for the lower extremity. Only the lower extremity motor assessment component of the Fugl-Meyer will be used for this study, which consists of 17 items.
Fugl-Meyer Assessment (Upper and lower extremity components). Available from: https://www.researchgate.net/publ
- 10-meter walk test [ Time Frame: Baseline to 4 weeks ]Performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Scoring is done by completing three trials and calculating the average of the three trials to obtain the velocity. The test may be completed at the subject's self-selected velocity and/or at the subject's fast velocity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271463
|Contact: Deborah Diaz, PT,PhDfirstname.lastname@example.org|
|Contact: Teresa A Bisson, PT,DPT,NCSemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Teresa Bisson, PT,DPT,NCS, ATP 612-624-2364 firstname.lastname@example.org|
|Principal Investigator:||Deborah Diaz, PT,PhD||Mary Baldwin University|
|Principal Investigator:||Teresa A Bisson, PT,DPT,NCS||University of Minnesota|