Long Term Split Belt Treadmill Training for Stroke Recovery
2 other identifiers
interventional
34
1 country
1
Brief Summary
The purpose of this study is to determine whether split belt or conventional treadmill training can be used to treat walking pattern deficits from stroke and to determine whether this improves gait asymmetry and metabolic efficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jun 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2012
CompletedStudy Start
First participant enrolled
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedResults Posted
Study results publicly available
May 4, 2018
CompletedJanuary 14, 2019
January 1, 2019
4.7 years
April 5, 2012
December 1, 2017
January 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.
After training (week 14), and 3 months after training
Secondary Outcomes (2)
Change in Baseline Oxygen Intake
Post training (week 14), and 3 months follow up
Walking Speed
Baseline, post training, and 3 month follow up.
Study Arms (1)
Split-belt treadmill training
EXPERIMENTALSplit-belt treadmill exercise
Interventions
A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds.
Eligibility Criteria
You may qualify if:
- stroke or hemiparesis (\>6 months post stroke)
- able to walk but has residual gait deficit (including those who walk with a cane or walker)
- This is their first and only stroke
- Able to walk for 5 minutes at their self-paced speed
- Adults age 20-80
You may not qualify if:
- Cerebellar signs (e.g.ataxic hemiparesis)
- Any neurologic condition other than stroke
- Insulin dependent diabetes
- Congestive heart failure
- Peripheral artery disease with claudication
- Pulmonary or renal failure
- Unstable angina
- Uncontrolled hypertension (\>190/110 mmHg)
- Dementia
- Severe aphasia
- Orthopedic or pain conditions that limit walking
- Total joint replacement in the lower extremities
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.lead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
- University of Marylandcollaborator
- VA Office of Research and Developmentcollaborator
Study Sites (1)
Motion Analysis Lab in the Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Some subjects could not complete all of the tasks. Recruitment was also challenging.
Results Point of Contact
- Title
- Anthony Gonzalez
- Organization
- Kennedy Krieger Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Amy J Bastian, PhD, PT
Kennedy Krieger Institute and Johns Hopkins School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Amy J Bastian, Ph.D., PT
Study Record Dates
First Submitted
April 5, 2012
First Posted
July 20, 2012
Study Start
June 7, 2012
Primary Completion
February 24, 2017
Study Completion
September 30, 2017
Last Updated
January 14, 2019
Results First Posted
May 4, 2018
Record last verified: 2019-01