Training of Eccentric Lower Extremity Function After SCI

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Trained SCI Knee or Trained SCI 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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210-2205
      • D Michele basso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Individuals with no spinal cord injury or other neurological deficits.
No Intervention: Unexercised SCI Knee or 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. 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; 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; 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.; Other Names: DH Knee; DH Hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline in SCI specific Quality of Life score	baseline, 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 Neuromuscular Recovery Scale score	12 weeks, 16 weeks
Change from second baseline in balance function as measured by Berg Balance Scale score	12 weeks, 16 weeks
Change from second baseline in SCI specific Quality of Life score	12 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 peak magnitude of sagittal knee power absorption or frontal hip power during loading response	12 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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Notre Dame
• Investigators: Principal Investigator: D. Michele M Basso, Ohio State University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: July 11, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2014H0386