- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821845
Eccentric Motor Control After SCI
March 17, 2021 updated by: Michele Basso, Ohio State University
Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Observation of Hip and Knee Function
This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at slow to moderate speeds - targeted to rehabilitation eccentric function of the hip and knee.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI).
Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI.
This proposal aims to characterize eccentric motor control of the muscles about the hip and knee during locomotion and evaluate the efficacy of downhill gait training at slow speeds as an intervention to improve eccentric function of the hip joint and knee joint during walking.
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals from the community that are healthy and without musculoskeletal or orthopedic impairments will serve as healthy case-controls.
The individuals with chronic spinal cord injury will come from outpatient clinic referrals and former participants in locomotor training rehabilitation programs.
Description
Individuals with SCI:
Inclusion Criteria:
- medically approved
- discharged from outpatient rehabilitation for 6 months
- incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
- ability to take some steps overground and on the treadmill
- 18-90 years old.
- ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.
Exclusion Criteria:
- evidence of lower motor neuron injury in the legs
- use of botox in the past 3 months
- pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
- acute deep vein thrombosis
- skin wounds in regions where harness or hands provide support
- pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.
- cognitive conditions that preclude providing informed consent
- ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment
- persistent orthostatic hypotension (drop of BP >30mmHg in treadmill and harness equipment)
- hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study
- participation in any other concurrent exercise programs.
Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Control
Individuals with no spinal cord injury or other neurological deficits.
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Untrained and Trained SCI Hip and Knee
Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study.
Untrained individuals will complete 3 baseline measures and then complete eccentric training which will focus on rehabilitation of the hip joint or knee joint.
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Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period.
This intervention will be delivered by trained therapists.
In order to focus on rehabilitation of hip control or knee control, members of this group will be trained at slow to moderate gait speeds,
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Change from baseline in peak magnitude of frontal hip loading response as measured by the peak magnitude of frontal hip power absorption during the weight acceptance phase of walking
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Neuromuscular Recovery Scale score
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Change from baseline in balance function as measured by the Berg Balance Scale score
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Change from Baseline in SCI specific Quality of Life score
Time Frame: baseline, 12 weeks
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baseline, 12 weeks
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Change from second baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in peak magnitude of frontal hip loading response as measured by the peak magnitude of frontal hip power absorption during the weight acceptance phase of walking
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in quadriceps eccentric contraction capacity as measured by difference in maximum voluntary eccentric knee flexion contraction before and after eccentric exercise targeting the contralateral quadriceps
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in Neuromuscular Recovery Scale score
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in balance function as measured by Berg Balance Scale score
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Change from second baseline in SCI specific Quality of Life score
Time Frame: 12 weeks, 16 weeks
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12 weeks, 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: D. Michele M Basso, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
July 11, 2015
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
July 4, 2016
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014H0386-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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