Error Based Learning for Restoring Gait Symmetry Post-Stroke

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Michael Lewek, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01598675
First received: May 8, 2012
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Stroke
Other: Same Belt Speeds
Other: Different Belt Speeds
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Error Based Learning for Restoring Gait Symmetry Post-Stroke

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from baseline in spatiotemporal gait symmetry after 6 weeks of training [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the Stroke Impact Scale

  • Change from baseline in metabolic efficiency after 6 weeks of training [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of their training, expected to be about 6 weeks ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the Stroke Impact Scale

  • Change from baseline in metabolic efficiency at 1 month follow up [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.


Enrollment: 48
Study Start Date: January 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training
Other: Same Belt Speeds
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
Experimental: Gait Asymmetry
Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training
Other: Different Belt Speeds
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.
Experimental: Gait Symmetry
Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training
Other: Different Belt Speeds
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.

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.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01598675

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Michael D Lewek, PT, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Michael Lewek, PhD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01598675     History of Changes
Other Study ID Numbers: 11-1240  R21HD068805 
Study First Received: May 8, 2012
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
stroke
Gait
walking

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 23, 2016