Skip to main content
OpenTrials
Completed

NCT Number: NCT01598675

Error Based Learning for Restoring Gait Symmetry Post-Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Same Belt Speeds

Other

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

Different Belt Speeds

Other

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 outcomes

  1. 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

    Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.

Secondary outcomes

  1. 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

    Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.

  2. 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

    Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment

  3. 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

    Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test

  4. 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

    Quality of Life will be assessed using the Stroke Impact Scale

  5. 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

    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.

  6. 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

    Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.

  7. 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

    Gait speed is measured in m/sec by having participants walk across a 14' pressure sensitive mat.

  8. 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

    Balance will be assessed using the Berg Balance Scale, 4square step test, and the Functional Gait Assessment

  9. 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

    Endurance will be measured as the distance walked (in meters) during the 6 Minute Walk Test

  10. 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

    Quality of Life will be assessed using the Stroke Impact Scale

  11. 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

    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.

  12. 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

    Community ambulation is assessed using Step Watch Monitors (SAMs) which will be worn daily for a minimum of 7 days during waking hours.

  13. 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

    Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 15, 2012
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.