Clinical trial NCT01598675: Error Based Learning for Restoring Gait Symmetry Post-Stroke
Official title: Error Based Learning for Restoring Gait Symmetry Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Gait
walking
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-05-15
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in spatiotemporal gait symmetry after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary outcomes:
measure: Change from baseline in gait speed after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in balance after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in endurance after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in quality of life after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in metabolic efficiency after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in community ambulation after 6 weeks of training
timeFrame: participants will be followed for the duration of their training, expected to be about 6 weeks
measure: Change from baseline in gait speed at 1 month follow-up
timeFrame: 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
measure: Change from baseline in balance at 1 month follow up
timeFrame: 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
measure: Change from baseline in endurance at 1 month follow up
timeFrame: 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
measure: Change from baseline in quality of life at 1 month follow up
timeFrame: 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
measure: Change from baseline in metabolic efficiency at 1 month follow up
timeFrame: 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
measure: Change from baseline in community ambulation at 1 month follow up
timeFrame: 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
measure: Change from baseline in spatiotemporal gait asymmetry at 1 month follow up
timeFrame: 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
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael D Lewek, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.