StrokeNCT01598675
Error Based Learning for Restoring Gait Symmetry Post-Stroke
A study testing Same Belt Speeds and Different Belt Speeds in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Same Belt Speeds and Different Belt Speeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Same Belt Speeds, Different Belt Speeds
- Keywords
- stroke, Gait, walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Belt SpeedsOther
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 SpeedsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training Receives: Other: Same Belt Speeds |
| Gait Asymmetry | Experimental | Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training Receives: Other: Different Belt Speeds |
| Gait Symmetry | Experimental | Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training Receives: Other: Different Belt Speeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
Secondary outcomes (13)
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.
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
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
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
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
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
Change from baseline in quality of life after 6 weeks of training
Quality of Life will be assessed using the Stroke Impact Scale
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
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.
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
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.
Measured: participants will be followed for the duration of their training, expected to be about 6 weeks
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.
Measured: 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
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
Measured: 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
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
Measured: 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
Change from baseline in quality of life at 1 month follow up
Quality of Life will be assessed using the Stroke Impact Scale
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michael D Lewek, PT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598675
- Sponsor's protocol ID
- 11-1240
- Other IDs
- R21HD068805
- Status last verified
- Apr 2016
- First submitted
- 8 May 2012
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32516300
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Error Based Learning for Restoring Gait Symmetry Post-Stroke
- ClinicalTrials.gov ID
- NCT01598675
- Acronym / sponsor ID
- 11-1240
- Conditions
- Stroke
- Keywords
- stroke, Gait, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Same Belt SpeedsSymmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training |
| Gait Asymmetry | Experimental | Other: Different Belt SpeedsError Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training |
| Gait Symmetry | Experimental | Other: Different Belt SpeedsError Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same Belt Speeds18 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 | Other | Control |
| Different Belt Speeds18 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. | Other | Gait Asymmetry, Gait Symmetry |
Primary outcome
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.
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32516300Ryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Lewek, PT, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same Belt Speeds and Different Belt Speeds in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.