ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02821845
Previous Study | Return to List | Next Study

Training of Eccentric Hip Function After SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02821845
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
University of Notre Dame
Information provided by (Responsible Party):
Michele Basso, Ohio State University

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 speeds - targeted to rehabilitation eccentric function of the hip.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: Trained SCI Hip Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Hip Function During Walking
Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Individuals with no spinal cord injury or other neurological deficits.
No Intervention: Unexercised SCI Hip
Individuals with spinal cord injury who have been discharged from a locomotor training programs at least 6 months prior to enrollment in this study. This group will serve as unexercised controls for the "Trained SCI Hip" group.
Experimental: 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 focus specifically on rehabilitation of the hip joint.
Behavioral: 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 hip control, members of this group will be trained at slow gait speeds,
Other Name: DH Hip




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821845


Contacts
Contact: Michele Basso, PT, EdD michele.basso@osumc.edu
Contact: Lise Worthen-Chaudhari, MFA, MS 614-304-1421 lise.worthen-chaudhari@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Lise Worthen-Chaudhari, MFA, MS    614-293-6281    lise.worthen-chaudhari@osumc.edu   
Contact: Ohio State Research Hotline    614-293-HERO      
Principal Investigator: Michele Basso, EdD         
Sub-Investigator: Lise Worthen-Chaudhari, MFA, MS         
Sponsors and Collaborators
Ohio State University
University of Notre Dame

Responsible Party: Michele Basso, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02821845     History of Changes
Other Study ID Numbers: 2014H0386-2
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries