Training of Eccentric Lower Extremity Function After SCI

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Behavioral: Trained SCI Knee or Trained SCI Hip


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Individuals with no spinal cord injury or other neurological deficits. | |
| No Intervention: Unexercised SCI Knee or Hip<br>Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. This group will serve as unexercised control for the Trained SCI Knee group or trained SCI Hip group | |
| Experimental: Trained SCI Knee or Trained SCI Hip<br>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. | Behavioral: Trained SCI Knee or Trained SCI Hip<br>* 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.<br>* Other names: DH Knee; DH Hip;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time 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 response |  | baseline, 12 weeks |