NCT02560506

Brief Summary

The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
9.7 years until next milestone

Results Posted

Study results publicly available

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

8.7 years

First QC Date

September 15, 2015

Results QC Date

January 3, 2020

Last Update Submit

April 22, 2026

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Change in Locomotor Performance During Treadmill Walking

    Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device

    change from Baseline in treadmill speed at 8 weeks

Secondary Outcomes (1)

  • Gait Kinematics

    change from Baseline in treadmill speed at 8 weeks

Other Outcomes (1)

  • Changes in Overground Gait Speed

    outcomes will be assessed prior to and following up to 8 weeks of training

Study Arms (1)

Elastic assisted treadmill walking

EXPERIMENTAL

Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training.

Device: Elastic assisted treadmill walking

Interventions

Elastic assisted treadmill walkingDEVICE

Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.

Also known as: Theraband(R)
Elastic assisted treadmill walking

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-progressive lesion between spinal levels C1-T10 of \> 3 months duration. Subjects with below T10 will be excluded due to potential lower motor neuron (LMN) injury
  • score \> 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in SCI. For the LEMS criteria, preliminary data indicate that subjects with LEMS \< 10 in the chronic stages do not recover walking
  • All subjects must require physical assistance to ambulate on the treadmill at a speed of 4.0 kmph at 0% body weight support (BWS)
  • All subjects will have an overground gait speed \<.8m/s
  • range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait
  • medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury)
  • able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population)
  • women of childbearing potential

You may not qualify if:

  • women who are pregnant will be excluded due to potential forces at trunk from BWS or pelvic assistance
  • those in concurrent physical therapy to eliminate effects of additional interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. T. George Hornby
Organization
Indiana University
tghornby@iu.edu
3123508291

Study Officials

  • Thomas G Hornby, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 25, 2015

Study Start

January 1, 2008

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 27, 2026

Results First Posted

April 27, 2026

Record last verified: 2026-04

Locations

US(1)