Development of Low Cost Devices to Increase Access to Treadmill Training

Spinal Cord Injury Clinical Trial

Official title:

Development of Low Cost Devices to Increase Access to Treadmill Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560506
• Other study ID #: Model Systems
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: December 26, 2016
• Start date: January 2008
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Rehabilitation Institute of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators will develop and assess the use of spring-loaded devices to assist limb swing and forward propulsion during body weight supported treadmill training (BWSTT) (Aim 1). Prototype models of both devices have been developed.

These devices will be:

1. simple to use in the clinical setting;

2. will be easily adjustable to alter the assistance provided; and,

3. will be able to quantify the amount of assistance necessary to facilitate normal stepping patterns.

The investigators will also evaluate short- and long-term adaptations in locomotor performance following BWSTT in individuals with incomplete SCI with the use of these devices. This information will identify the effects of variable assistance at the limbs or trunk to modulate muscle activity and/or motor performance (kinematics) during stepping to maximize walking recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Elastic assisted treadmill walking
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.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rehabilitation Institute of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in overground gait speed	Gait speed (m/s) will be collected during overground walking	outcomes will be assessed prior to and following up to 8 weeks of training	No
Primary	Change in locomotor performance during treadmill walking	Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device	outcomes will be assessed prior to and following up to 8 weeks of training	No
Secondary	Change in oxygen consumption	Metabolic costs (oxygen ml/kg/min) will be collected using a portable metabolic system (K4b2 , CosMed USA, Inc., Chicago) during treadmill training in both groups	outcomes will be assessed prior to and following up to 8 weeks of training	No