Clinical trial NCT02498548: Training of Eccentric Lower Extremity Function After SCI
Official title: Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Notre Dame
First posted: 2015-07-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.

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 knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip 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 sagittal knee power absorption or frontal Hip power during loading response
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Change from baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)
timeFrame: baseline, 12 weeks
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 sagittal knee power absorption or frontal hip power during loading response
timeFrame: 12 weeks, 16 weeks
measure: Change from second baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)
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: D Michele basso
state: Ohio
Study officials:
affiliation: Ohio State University
name: D. Michele M Basso
role: PRINCIPAL_INVESTIGATOR
References: