Training of Eccentric Lower Extremity Function After SCI

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Behavioral: Trained SCI Knee or Trained SCI Hip

• Registration Number: NCT02498548
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-11
• Study First Posted: 2015-07-15
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trained SCI Knee or Trained SCI Hip	Trained SCI Knee or Trained SCI Hip	Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. Training will specifically focus on rehabilitation of the knee joint or the hip joint.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 response	baseline, 12 weeks

Trial Locations

Locations (1)

D Michele basso; 🇺🇸 Columbus, Ohio, United States