Error Based Learning for Restoring Gait Symmetry Post-Stroke

This study is currently recruiting participants.
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
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: March 6, 2014
Last verified: March 2014
  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: Treadmill belts of dual-belt treadmill respond to encourage symmetric gait
Other: Treadmill belts of dual-belt treadmill respond to amplify asymmetric gait
Other: No difference in treadmill 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

Resource links provided by NLM:


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.


Estimated Enrollment: 54
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Belts of a dual belt treadmill will move at the same speed during training
Other: No difference in treadmill belt speeds
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax
Experimental: Error Augmentation
Belts of a dual belt treadmill may move at different speeds to amplify spatiotemporal gait asymmetry during training
Other: Treadmill belts of dual-belt treadmill respond to amplify asymmetric gait
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax
Experimental: Error Minimization
Belts of a dual belt treadmill may move at different speeds to encourage spatiotemporal gait symmetry during training
Other: Treadmill belts of dual-belt treadmill respond to encourage symmetric gait
18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598675

Contacts
Contact: Michael D Lewek, PT, PhD 919-966-9732 strokegait@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michael Lewek, PT, PhD    919-966-9732    mlewek@med.unc.edu   
Principal Investigator: Michael D Lewek, PT, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Michael D Lewek, PT, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

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: March 6, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 14, 2014