Error Based Learning for Restoring Gait Symmetry Post-Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same Belt Speeds
Different Belt Speeds
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, Gait, walking
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Gait Asymmetry
Gait Symmetry
Arm Description
Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training
Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training
Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in gait speed after 6 weeks of training
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
Change from baseline in balance after 6 weeks of training
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
Change from baseline in endurance after 6 weeks of training
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
Change from baseline in quality of life after 6 weeks of training
Quality of Life will be assessed using the Stroke Impact Scale
Change from baseline in metabolic efficiency after 6 weeks of training
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
Change from baseline in community ambulation after 6 weeks of training
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
Change from baseline in gait speed at 1 month follow-up
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
Change from baseline in balance at 1 month follow up
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
Change from baseline in endurance at 1 month follow up
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
Change from baseline in quality of life at 1 month follow up
Quality of Life will be assessed using the Stroke Impact Scale
Change from baseline in metabolic efficiency at 1 month follow up
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
Change from baseline in community ambulation at 1 month follow up
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
Change from baseline in spatiotemporal gait asymmetry at 1 month follow up
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
Full Information
NCT ID
NCT01598675
First Posted
May 8, 2012
Last Updated
February 11, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01598675
Brief Title
Error Based Learning for Restoring Gait Symmetry Post-Stroke
Official Title
Error Based Learning for Restoring Gait Symmetry Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Walking after stroke is characterized by reduced gait speed and the presence of interlimb spatiotemporal asymmetry. These step length and stance time asymmetries can be energy inefficient, challenge balance control, increase the risk of falls and injury, and limit functional mobility. Current rehabilitation to improve gait is based on one of two competing motor learning strategies: minimizing or augmenting symmetry errors during training. Conventional rehabilitation often involves walking on a treadmill while therapists attempt to minimize symmetry errors during training. Although this approach can successfully improve gait speed, it does not produce long-term changes in symmetry. Conversely, augmenting or amplifying symmetry errors has been produced by walking on a split belt treadmill with the belts set at different fixed speeds. While this approach produced an 'after-effect' resulting in step length symmetry for short periods of time, with some evidence of long term learning in people with stroke, it had no influence on stance time asymmetry. The investigators propose that patients need real-time proprioceptive feedback of symmetry errors so that they are actively engaged in the learning process. For this project, the investigators developed and validated a novel, responsive, 'closed loop' control system, using a split-belt instrumented treadmill that continuously adjusts the difference in belt speeds to be proportional to the patient's current asymmetry. Using this system, the investigators can either augment or minimize asymmetry on a step-by-step basis to determine which motor learning strategy produces the largest improvement in overground spatiotemporal symmetry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Gait, walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training
Arm Title
Gait Asymmetry
Arm Type
Experimental
Arm Description
Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training
Arm Title
Gait Symmetry
Arm Type
Experimental
Arm Description
Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training
Intervention Type
Other
Intervention Name(s)
Same Belt Speeds
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Different Belt Speeds
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in spatiotemporal gait symmetry after 6 weeks of training
Description
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in gait speed after 6 weeks of training
Description
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in balance after 6 weeks of training
Description
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in endurance after 6 weeks of training
Description
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in quality of life after 6 weeks of training
Description
Quality of Life will be assessed using the Stroke Impact Scale
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in metabolic efficiency after 6 weeks of training
Description
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in community ambulation after 6 weeks of training
Description
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
Time Frame
participants will be followed for the duration of their training, expected to be about 6 weeks
Title
Change from baseline in gait speed at 1 month follow-up
Description
Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in balance at 1 month follow up
Description
Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in endurance at 1 month follow up
Description
Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in quality of life at 1 month follow up
Description
Quality of Life will be assessed using the Stroke Impact Scale
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in metabolic efficiency at 1 month follow up
Description
Metabolic efficiency is measured as the metabolic cost of transport (MCOT) using a portable metabolic cart to assess cardiorespiratory gas exchange during the 6 Minute Walk Test.
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in community ambulation at 1 month follow up
Description
Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
Title
Change from baseline in spatiotemporal gait asymmetry at 1 month follow up
Description
Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.
Time Frame
participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Lewek, PT, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32516300
Citation
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.
Results Reference
derived
Learn more about this trial
Error Based Learning for Restoring Gait Symmetry Post-Stroke
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