Training of Eccentric Lower Extremity Function After SCI

NCT ID: NCT02498548

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-10-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Individuals with no spinal cord injury or other neurological deficits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Trained SCI Knee or Trained SCI Hip

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DH Knee; DH Hip

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Notre Dame

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Michele Basso

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

D. Michele M Basso

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

D Michele basso

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2014H0386

Identifier Type: -

Identifier Source: org_study_id