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Completed

NCT Number: NCT02498548

Training of Eccentric Lower Extremity Function After SCI

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

D Michele basso

Columbus, Ohio, 43210-2205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: DH Knee; DH Hip

Primary outcomes

  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 outcomes

  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 sagittal knee power absorption or frontal Hip power during loading response

    Time frame: baseline, 12 weeks

Other outcomes

  1. Change from baseline in maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect)

    Time frame: baseline, 12 weeks

  2. Change from baseline in Neuromuscular Recovery Scale score

    Time frame: baseline, 12 weeks

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

    Time frame: baseline, 12 weeks

  4. Change from Baseline in SCI specific Quality of Life score

    Time frame: baseline, 12 weeks

  5. 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

  6. 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

  7. Change from second baseline in peak magnitude of sagittal knee power absorption or frontal hip power during loading response

    Time frame: 12 weeks, 16 weeks

  8. 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)

    Time frame: 12 weeks, 16 weeks

  9. Change from second baseline in Neuromuscular Recovery Scale score

    Time frame: 12 weeks, 16 weeks

  10. Change from second baseline in balance function as measured by Berg Balance Scale score

    Time frame: 12 weeks, 16 weeks

  11. Change from second baseline in SCI specific Quality of Life score

    Time frame: 12 weeks, 16 weeks

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • University of Notre Dame

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2015
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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