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Assessing Leg Control in People With Chronic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271463
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The purpose of this study is to compare the clinometric (psychometric) properties of the SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how well each measure predicts walking speed using the 10 meter walk test.

Condition or disease Intervention/treatment
Chronic Stroke Behavioral: Selective Control Assessment of Lower Extremity (SCALE)

Detailed Description:

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).

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with chronic stroke
Criteria

Inclusion Criteria:

  • Adults between 18 and 79 years of age who have sustained a chronic cerebrovascular accident (stroke) with known corticospinal tract damage
  • At least one year after onset
  • Ability to walk
  • Ability to understand and follow simple instructions
  • Written informed consent obtained from subject

Exclusion Criteria:

  • History of cerebellar infarct, traumatic brain injury, tumor, etc.
  • Rigidity, ataxia, or other Cerebellar or Basal Ganglia signs or symptoms.
  • Hospitalizations in the past 6 months.
  • Neurosurgical or Musculoskeletal surgery in last 12 months.
  • Neurological or Musculoskeletal injury within the past month.
  • Pain that interferes with the ability to assume side-lying position.
  • Medication for hypertonicity: Participants may be on medicine for abnormal tone.

However, there must not be any of the following:

  1. Change in dosage or type of medication during the past 6 months
  2. Botox injection(s) within 6 months.

Information from the National Library of Medicine

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


Contacts
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Contact: Deborah Diaz, PT,PhD 540-887-4087 ddiaz@marybaldwin.edu
Contact: Teresa A Bisson, PT,DPT,NCS 612-624-2364 tbisson@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Teresa Bisson, PT,DPT,NCS, ATP    612-624-2364    tbisson@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Deborah Diaz, PT,PhD Mary Baldwin University
Principal Investigator: Teresa A Bisson, PT,DPT,NCS University of Minnesota
Publications:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03271463    
Other Study ID Numbers: PMR-2017-25802
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
stroke
selective voluntary motor control
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases