Eccentric Motor Control After SCI

• ClinicalTrials.gov Identifier: NCT02821845
• Recruitment Status: Completed
• First Posted: July 4, 2016
• Last Update Posted: March 22, 2021
• Sponsor: Ohio State University
• Collaborator: University of Notre Dame
• Information provided by (Responsible Party): Michele Basso, Ohio State University

Study Description

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 slow to moderate speeds - targeted to rehabilitation eccentric function of the hip and knee.

Condition or disease	Intervention/treatment
Spinal Cord Injury	Behavioral: Untrained and Trained SCI Hip or Knee

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 hip and knee during locomotion and evaluate the efficacy of downhill gait training at slow speeds as an intervention to improve eccentric function of the hip joint and knee joint during walking.

Study Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Observation of Hip and Knee Function
• Study Start Date: June 2015
• Actual Primary Completion Date: October 2019
• Actual Study Completion Date: October 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Control; Individuals with no spinal cord injury or other neurological deficits.
Untrained and Trained SCI Hip and Knee; Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. Untrained individuals will complete 3 baseline measures and then complete eccentric training which will focus on rehabilitation of the hip joint or knee joint.	Behavioral: Untrained and Trained SCI Hip or Knee; 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 hip control or knee control, members of this group will be trained at slow to moderate gait speeds,; Other Name: DH Hip or Knee

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test) [ Time Frame: baseline, 12 weeks ]

Secondary Outcome Measures :

1. Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test) [ Time Frame: baseline, 12 weeks ]
2. Change from baseline in peak magnitude of frontal hip loading response as measured by the peak magnitude of frontal hip power absorption during the weight acceptance phase of walking [ Time Frame: baseline, 12 weeks ]

Other Outcome Measures:

1. Change from baseline in Neuromuscular Recovery Scale score [ Time Frame: baseline, 12 weeks ]
2. Change from baseline in balance function as measured by the Berg Balance Scale score [ Time Frame: baseline, 12 weeks ]
3. Change from Baseline in SCI specific Quality of Life score [ Time Frame: baseline, 12 weeks ]
4. Change from second baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test) [ Time Frame: 12 weeks, 16 weeks ]
5. Change from second baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test) [ Time Frame: 12 weeks, 16 weeks ]
6. Change from second baseline in peak magnitude of frontal hip loading response as measured by the peak magnitude of frontal hip power absorption during the weight acceptance phase of walking [ Time Frame: 12 weeks, 16 weeks ]
7. Change from second baseline in quadriceps eccentric contraction capacity as measured by difference in maximum voluntary eccentric knee flexion contraction before and after eccentric exercise targeting the contralateral quadriceps [ Time Frame: 12 weeks, 16 weeks ]
8. Change from second baseline in Neuromuscular Recovery Scale score [ Time Frame: 12 weeks, 16 weeks ]
9. Change from second baseline in balance function as measured by Berg Balance Scale score [ Time Frame: 12 weeks, 16 weeks ]
10. Change from second baseline in SCI specific Quality of Life score [ Time Frame: 12 weeks, 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Individuals from the community that are healthy and without musculoskeletal or orthopedic impairments will serve as healthy case-controls. The individuals with chronic spinal cord injury will come from outpatient clinic referrals and former participants in locomotor training rehabilitation programs.

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.

Contacts and Locations

Locations

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

University of Notre Dame

Investigators

• Principal Investigator: D. Michele M Basso; Ohio State University

More Information

• Responsible Party: Michele Basso, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT02821845
• Other Study ID Numbers: 2014H0386-2
• First Posted: July 4, 2016
• Last Update Posted: March 22, 2021
• Last Verified: March 2021

Additional relevant MeSH terms:

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