Training of Eccentric Lower Extremity Function After SCI

The Ohio State University

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Behavioral: Trained SCI Knee or Trained SCI Hip

Study type: Interventional

Funder types: Other

Identifiers

NCT02498548

2014H0386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 3 patient groups

Control

No Intervention group

Description:

Individuals with no spinal cord injury or other neurological deficits.

Unexercised SCI Knee or Hip

No Intervention group

Description:

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

Trained SCI Knee or Trained SCI Hip

Experimental group

Description:

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.

Treatment:

Behavioral: Trained SCI Knee or Trained SCI Hip