Assessing Leg Control in People With Chronic Stroke

NCT03271463 | Completed

• 1 other identifier: PMR-2017-25802
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

stroke; selective voluntary motor control

Outcome Measures

Primary Outcomes (1)

• Selective Control Assessment of Lower Extremity (SCALE)

  Each item is rated 2-0, 2 being Normal and 0 being Unable to Move

  Baseline to 4 weeks

Secondary Outcomes (2)

• Fugl-Meyer Assessment-Lower Extremity component (FMA-LE)

  Baseline to 4 weeks

• 10-meter walk test

  Baseline to 4 weeks

Study Arms (1)

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)

Interventions

Selective Control Assessment of Lower Extremity (SCALE) 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)

Reliability/Validity of SCALE Assessment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic stroke

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 1135616 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Deborah Diaz, PT,PhD

  Mary Baldwin University

  PRINCIPAL INVESTIGATOR

• Teresa A Bisson, PT,DPT,NCS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: August 5, 2018
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)