Assessing Leg Control in People With Chronic Stroke

NCT ID: NCT03271463

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-05
• Study Completion Date: 2020-11-05

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).

Conditions

Chronic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Reliability/Validity of SCALE Assessment

Reliability + validity of the Selective Control Assessment of Lower Extremity (SCALE) in people with chronic stroke.

Selective Control Assessment of Lower Extremity (SCALE)

Intervention Type: BEHAVIORAL

Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)

Interventions

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)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Diaz, PT,PhD

Role: PRINCIPAL_INVESTIGATOR

Mary Baldwin University

Teresa A Bisson, PT,DPT,NCS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 1135616 (View on PubMed)

Other Identifiers

PMR-2017-25802

Identifier Type: -

Identifier Source: org_study_id