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Training of Eccentric Lower Extremity Function After SCI

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trained SCI Knee or Trained SCI Hip

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

D Michele basso

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control

Unexercised SCI Knee or Hip

Trained SCI Knee or Trained SCI Hip

Arm Description

Individuals with no spinal cord injury or other neurological deficits.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)

Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response

Full Information

NCT ID

NCT02498548

First Posted

July 9, 2015

Last Updated

March 17, 2021

Sponsor

Ohio State University

Collaborators

University of Notre Dame

1. Study Identification

Unique Protocol Identification Number

NCT02498548

Brief Title

Training of Eccentric Lower Extremity Function After SCI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

Collaborators

University of Notre Dame

4. Oversight

Data Monitoring Committee

5. 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 moderate speeds - targeted to rehabilitation eccentric function of the knee or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Individuals with no spinal cord injury or other neurological deficits.

Arm Title

Unexercised SCI Knee or Hip

Arm Type

No Intervention

Arm Description

Arm Title

Trained SCI Knee or Trained SCI Hip

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Trained SCI Knee or Trained SCI Hip

Other Intervention Name(s)

DH Knee; DH Hip

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)

Time Frame

baseline, 12 weeks

Title

Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response

Time Frame

baseline, 12 weeks

Other Pre-specified Outcome Measures:

Title

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

Title

Change from baseline in Neuromuscular Recovery Scale score

Time Frame

baseline, 12 weeks

Title

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

Time Frame

baseline, 12 weeks

Title

Change from Baseline in SCI specific Quality of Life score

Time Frame

baseline, 12 weeks

Title

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

Title

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

Title

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

Title

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

Title

Change from second baseline in Neuromuscular Recovery Scale score

Time Frame

12 weeks, 16 weeks

Title

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

Time Frame

12 weeks, 16 weeks

Title

Change from second baseline in SCI specific Quality of Life score

Time Frame

12 weeks, 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D. Michele M Basso

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

D Michele basso

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210-2205

Country

United States

12. IPD Sharing Statement

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Training of Eccentric Lower Extremity Function After SCI

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