Task-specificity for Locomotor Recovery Following 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. Identifier: NCT03144388
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
George Hornby, Indiana University

Brief Summary:
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation are critical to mobility outcomes following neurological injury. Specifically, the specificity, amount and intensity of physical interventions (i.e., practice) may influence specific outcomes in the patient population treated. In ambulatory patients with iSCI, there are very few studies that have controlled for or targeted these training variables or their influence on locomotor recovery. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of task-specific practice during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting. The goal of the present study is to delineate the relative contributions of amount of task-specific training on locomotor outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the investigators anticipated non-specific (i.e., non-stepping) training activities would result in smaller improvements as compared to task-specific (stepping) training. The investigators will investigate the effects of such training on walking performance and kinematics, as well as the impairments thought to contribute to walking performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI or other acute-onset neurological disorders.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Procedure: Variable Stepping Training Procedure: Variable Non-specific Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-group with optional crossover
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessors at each measurement
Primary Purpose: Treatment
Official Title: Task-specificity for Locomotor Recovery Following SCI
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Variable Stepping Training
High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs.
Procedure: Variable Stepping Training
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments

Active Comparator: Variable Non-specific Training
High intensity non-stepping training, including balance, strength, and cycling tasks
Procedure: Variable Non-specific Training
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments

Primary Outcome Measures :
  1. Walking Speed [ Time Frame: change in walking speed from baseline testing to post-testing following 6 weeks of training ]
    fastest comfortable walking speed over short distances

Secondary Outcome Measures :
  1. Walking Distance [ Time Frame: change in walking speed from baseline testing to post-testing following 6 weeks of training ]
    distance covered over 6 minutes

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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • individuals with chronic (>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
  • ages 18-75 years
  • ability to walk without physical assistance but with below-knee braces and assistive devices as needed
  • self-selected gait speeds between 0.01-1.0 m/s.
  • not currently receiving physical therapy

Exclusion Criteria:

  • uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
  • active heterotopic ossification
  • recurrent history of lower extremity fractures
  • previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
  • history of botulinum toxin injection < 3 months prior
  • Patients who are prescribed intrathecal or oral anti-spastics should agree to limit changes in anti-spastic use throughout the training and testing period.

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 identifier (NCT number): NCT03144388

Contact: Thomas G Hornby 3123508291

United States, Indiana
Rehabilitation Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46254-2607
Contact: Thomas G Hornby, PT, PHD    312-350-8291   
Sponsors and Collaborators
Indiana University
Principal Investigator: Thomas Hornby Indiana University School of Medicine

Responsible Party: George Hornby, Professor, Indiana University Identifier: NCT03144388     History of Changes
Other Study ID Numbers: IU1705279110
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data available as requested

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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