Error Based Learning for Restoring Gait Symmetry Post-Stroke

Stroke Clinical Trial

Official title:

Error Based Learning for Restoring Gait Symmetry Post-Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598675
• Other study ID #: 11-1240
• Secondary ID: R21HD068805
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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.	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	Change from baseline in quality of life after 6 weeks of training	Quality of Life will be assessed using the Stroke Impact Scale	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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.	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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.	participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary	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.	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
Secondary	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	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
Secondary	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	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
Secondary	Change from baseline in quality of life at 1 month follow up	Quality of Life will be assessed using the Stroke Impact Scale	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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