Training of Eccentric Lower Extremity Function After SCI

NCT02498548 | Completed

• 1 other identifier: 2014H0386
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

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

  baseline, 12 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (11)

• 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 baseline in Neuromuscular Recovery Scale score

  baseline, 12 weeks

• Change from baseline in balance function as measured by the Berg Balance Scale score

  baseline, 12 weeks

Study Arms (3)

Control

NO INTERVENTION

Individuals with no spinal cord injury or other neurological deficits.

Unexercised SCI Knee or Hip

NO INTERVENTION

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

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

Interventions

Trained SCI Knee or Trained SCI Hip BEHAVIORAL

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.

Also known as: DH Knee; DH Hip

Trained SCI Knee or Trained SCI Hip

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old.
• ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• University of Notre Dame: collaborator

Study Sites (1)

D Michele basso

Columbus, Ohio, 43210-2205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• D. Michele M Basso

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 15, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

US (1)