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

NCT03744286 | Active Not Recruiting

• 1 other identifier: STU00207310
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Balance Slip

EXPERIMENTAL

* 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

Interventions

Slip Training DEVICE

-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.

Balance Slip

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Max Näder Center

Model Details: This is a 2-visit clinical trial to test a novel prototype slip inducing platform device for feasibility and not health outcomes.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: November 16, 2018
• Study Start: December 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)