Clinical trial NCT02821845: Eccentric Motor Control After SCI
Official title: Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Observation of Hip and Knee Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Notre Dame
First posted: 2016-07-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
timeFrame: baseline, 12 weeks
measure: 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
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Change from baseline in Neuromuscular Recovery Scale score
timeFrame: baseline, 12 weeks
measure: Change from baseline in balance function as measured by the Berg Balance Scale score
timeFrame: baseline, 12 weeks
measure: Change from Baseline in SCI specific Quality of Life score
timeFrame: baseline, 12 weeks
measure: Change from second baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
timeFrame: 12 weeks, 16 weeks
measure: Change from second baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
timeFrame: 12 weeks, 16 weeks
measure: 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
timeFrame: 12 weeks, 16 weeks
measure: 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
timeFrame: 12 weeks, 16 weeks
measure: Change from second baseline in Neuromuscular Recovery Scale score
timeFrame: 12 weeks, 16 weeks
measure: Change from second baseline in balance function as measured by Berg Balance Scale score
timeFrame: 12 weeks, 16 weeks
measure: Change from second baseline in SCI specific Quality of Life score
timeFrame: 12 weeks, 16 weeks
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: D. Michele M Basso
role: PRINCIPAL_INVESTIGATOR
References: