Clinical trial NCT03271463: Assessing Leg Control in People With Chronic Stroke
Official title: Lower Extremity Selective Voluntary Motor Control in Adults With Chronic Stroke: Comparing the SCALE Assessment to the Fugl-Meyer Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stroke
Keywords: stroke
selective voluntary motor control
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic stroke

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.

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).

Eligibility 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.

Primary outcomes:
measure: Selective Control Assessment of Lower Extremity (SCALE)
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment-Lower Extremity component (FMA-LE)
timeFrame: Baseline to 4 weeks
measure: 10-meter walk test
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Mary Baldwin University
name: Deborah Diaz, PT,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Teresa A Bisson, PT,DPT,NCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.