Back to resultsDevelopment of Low Cost Devices to Increase Access to Treadmill Training
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elastic assisted treadmill walking
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
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
Sites / Locations
- Rehabilitation Institute of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elastic assisted treadmill walking
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in locomotor performance during treadmill walking
Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02560506
First Posted
September 15, 2015
Last Updated
December 26, 2016
Sponsor
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT02560506
Brief Title
Development of Low Cost Devices to Increase Access to Treadmill Training
Official Title
Development of Low Cost Devices to Increase Access to Treadmill Training
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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:
simple to use in the clinical setting;
will be easily adjustable to alter the assistance provided; and,
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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elastic assisted treadmill walking
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Elastic assisted treadmill walking
Other Intervention Name(s)
Theraband(R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in locomotor performance during treadmill walking
Description
Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device
Time Frame
outcomes will be assessed prior to and following up to 8 weeks of training
Secondary Outcome Measure Information:
Title
Change in oxygen consumption
Description
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
Time Frame
outcomes will be assessed prior to and following up to 8 weeks of training
Other Pre-specified Outcome Measures:
Title
Changes in overground gait speed
Description
Gait speed (m/s) will be collected during overground walking
Time Frame
outcomes will be assessed prior to and following up to 8 weeks of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Hornby, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of Low Cost Devices to Increase Access to Treadmill Training
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