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Training of Eccentric Lower Extremity Function After SCI

Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02498548
Enrollment
49
Registered
2015-07-15
Start date
2015-06-30
Completion date
2019-10-31
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

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.

Interventions

BEHAVIORALTrained SCI Knee or Trained SCI Hip

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 knee control or hip control, members of this group will be trained at slow to moderate gait speeds.

Sponsors

University of Notre Dame
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)baseline, 12 weeks

Secondary

MeasureTime frame
Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)baseline, 12 weeks
Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading responsebaseline, 12 weeks

Other

MeasureTime frame
Change from Baseline in SCI specific Quality of Life scorebaseline, 12 weeks
Change from second baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)12 weeks, 16 weeks
Change from second baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)12 weeks, 16 weeks
Change from second baseline in peak magnitude of sagittal knee power absorption or frontal hip power during loading response12 weeks, 16 weeks
Change from baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)baseline, 12 weeks
Change from second baseline in Neuromuscular Recovery Scale score12 weeks, 16 weeks
Change from second baseline in balance function as measured by Berg Balance Scale score12 weeks, 16 weeks
Change from second baseline in SCI specific Quality of Life score12 weeks, 16 weeks
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)12 weeks, 16 weeks
Change from baseline in Neuromuscular Recovery Scale scorebaseline, 12 weeks
Change from baseline in balance function as measured by the Berg Balance Scale scorebaseline, 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026