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Investigation Into an Innovative, Clinical Slip Inducing Device in the Chronic Incomplete Spinal Cord Population

Primary Purpose

Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slip Training
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with a traumatic or non-traumatic incomplete spinal cord injury at least 6 months ago
  • Between the ages of 18-85 years old.
  • Ambulates as their primary means of mobility
  • Able to walk without cane/crutch/walker for 30 feet.
  • Weight less than 275 lbs.
  • Medical clearance from physician

Exclusion Criteria:

  • Uses a wheelchair as primary means of mobility
  • Recent (<6 months) lower extremity fracture
  • Other neurological diagnoses that would impact balance such as peripheral neuropathy, stroke, brain injury, etc.
  • Lower extremity amputation
  • Currently pregnant
  • Uses knee-ankle-foot-orthosis for mobility.

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balance Slip

Arm Description

Perform standard clinical balance assessments Determine the optimal slip distance by 10 passes each with plank movement of 2", 4", 6" and 8" on visit 1

Outcomes

Primary Outcome Measures

Change in Static Balance
During the static stability test, the participants will be instructed to stand on the force plate as still as possible for 60 seconds with their eyes open. After 2 minutes of rest, the task will be repeated with the eyes closed. The excursions of the center of pressure (COP) and EMG of leg muscles will be analyzed. The AMTI Force System from Water Town, MA will be used to for this test. The platform is placed on the floor and subjects stand on the device. The force plate measures the forces and movements applied to its top surface.
Change in Dynamic Balance
During the dynamic stability test, the ability to voluntarily displace the COP to a maximum distance without losing balance will be assessed (Limits of stability (LOS) test). The participant will be instructed to lean forward, backward, left, and right, hold the position for ~5 seconds and return back to the initial/center position. The AMTI Force System from Water Town, MA will be used to for this test.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
October 24, 2022
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT03744286
Brief Title
Investigation Into an Innovative, Clinical Slip Inducing Device in the Chronic Incomplete Spinal Cord Population
Official Title
Investigation Into an Innovative, Clinical Slip Inducing Device in the Chronic Incomplete Spinal Cord Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this project is to fully test a newly developed affordable cost variable slip inducer in the ambulatory, incomplete spinal cord population. It is a self-contained device using a moving serial plank mechanism with wheels on the underside of each plank that allow for structured slips while a person walks over the planks with a harness for safety.
Detailed Description
All planks appear the same but can be adjusted on the underside allowing for it to be stable or can allow a slip in the forward and/or backward direction of up to 8 inches. This distance was determined from a review of slip bio-mechanics that noted that a slip is likely to occur when a slip distance exceeds 10 cm (3.9 inches) with the probability of recovery decreasing as the distance increases. The first goal of the project is to determine the optimal distance required for individuals with incomplete spinal cord injuries to have a 50% fall rate, as healthy individuals were found to have a fall rate of 50% at 11 inches. Investigators will then look at common clinical assessments and examine their ability to predict an individual's ability to recover from the individual's identified optimal slip distance. Investigators will also look at within session training effect on a person's balance control following a training session using the device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a 2-visit clinical trial to test a novel prototype slip inducing platform device for feasibility and not health outcomes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balance Slip
Arm Type
Experimental
Arm Description
Perform standard clinical balance assessments Determine the optimal slip distance by 10 passes each with plank movement of 2", 4", 6" and 8" on visit 1
Intervention Type
Device
Intervention Name(s)
Slip Training
Intervention Description
-On a separate day (visit 2), using the identified optimal distance, a training session that involves 24 passes on the device where 1-2 planks move will be performed.
Primary Outcome Measure Information:
Title
Change in Static Balance
Description
During the static stability test, the participants will be instructed to stand on the force plate as still as possible for 60 seconds with their eyes open. After 2 minutes of rest, the task will be repeated with the eyes closed. The excursions of the center of pressure (COP) and EMG of leg muscles will be analyzed. The AMTI Force System from Water Town, MA will be used to for this test. The platform is placed on the floor and subjects stand on the device. The force plate measures the forces and movements applied to its top surface.
Time Frame
Assessment Session 1 (baseline test, Will occur at the start of Visit 1, Day 1), Assessment Session 2 (conducted before Training during Visit 2, Day 2), Assessment Session 3 (Post Training Assessment; conducted at the end of Training Visit 2, Day 2)
Title
Change in Dynamic Balance
Description
During the dynamic stability test, the ability to voluntarily displace the COP to a maximum distance without losing balance will be assessed (Limits of stability (LOS) test). The participant will be instructed to lean forward, backward, left, and right, hold the position for ~5 seconds and return back to the initial/center position. The AMTI Force System from Water Town, MA will be used to for this test.
Time Frame
Assessment Session 1 (baseline test, Will occur at the start of Visit 1, Day 1), Assessment Session 2 (conducted before Training during Visit 2, Day 2), Assessment Session 3 (Post Training Assessment; conducted at the end of Training Visit 2, Day 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with a traumatic or non-traumatic incomplete spinal cord injury at least 6 months ago Between the ages of 18-85 years old. Ambulates as their primary means of mobility Able to walk without cane/crutch/walker for 30 feet. Weight less than 275 lbs. Medical clearance from physician Exclusion Criteria: Uses a wheelchair as primary means of mobility Recent (<6 months) lower extremity fracture Other neurological diagnoses that would impact balance such as peripheral neuropathy, stroke, brain injury, etc. Lower extremity amputation Currently pregnant Uses knee-ankle-foot-orthosis for mobility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation Into an Innovative, Clinical Slip Inducing Device in the Chronic Incomplete Spinal Cord Population

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