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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Slip Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance Slip; 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	Device: Slip Training; -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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
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.	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)

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: STU00207310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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