Error Based Learning for Restoring Gait Symmetry Post-Stroke
2 other identifiers
interventional
48
1 country
1
Brief Summary
Many of the 780,000 people affected by stroke each year are left with slow, asymmetric walking patterns. The proposed project will evaluate the effectiveness of two competing motor learning approaches to restore symmetric gait for faster, more efficient, and safer walking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jan 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 15, 2019
April 1, 2016
3.9 years
May 8, 2012
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in spatiotemporal gait symmetry after 6 weeks of training
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary Outcomes (13)
Change from baseline in gait speed after 6 weeks of training
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in balance after 6 weeks of training
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in endurance after 6 weeks of training
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in quality of life after 6 weeks of training
participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in metabolic efficiency after 6 weeks of training
participants will be followed for the duration of their training, expected to be about 6 weeks
- +8 more secondary outcomes
Study Arms (3)
Control
ACTIVE COMPARATORSymmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training
Gait Asymmetry
EXPERIMENTALError Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training
Gait Symmetry
EXPERIMENTALError Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training
Interventions
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Control-Dual-belted treadmill belts respond to encourage symmetric gait
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Treadmill belts of dual-belted treadmill respond either to amplify asymmetric gait or encourage symmetric gait.
Eligibility Criteria
You may qualify if:
- ability to walk \>10 m overground without physical assistance
- overground comfortable gait speed (CGS) \< 1.0 m/s (using assistive devices and bracing below the knee as needed)
- able to walk independently on the treadmill at \>80% CGS
- exhibits stance time and/or step length asymmetry during CGS
You may not qualify if:
- cerebellar lesion
- uncontrolled cardiorespiratory/metabolic disease (cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema)or other neurological or orthopedic disorders that may affect gait training
- botulinum toxin to the lower limb in the past 6 months
- a history of balance deficits or unexplained falls not related to the stroke
- uncontrolled seizures
- concurrent physical therapy
- Mini-Mental Status Exam (MMSE) \< 24
- communication impairments which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Ryan HP, Husted C, Lewek MD. Improving Spatiotemporal Gait Asymmetry Has Limited Functional Benefit for Individuals Poststroke. J Neurol Phys Ther. 2020 Jul;44(3):197-204. doi: 10.1097/NPT.0000000000000321.
PMID: 32516300DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Lewek, PT, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 15, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 15, 2019
Record last verified: 2016-04