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

NCT ID: NCT03744286

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Slip Training

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Director Max Näder Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Jayaraman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00207310

Identifier Type: -

Identifier Source: org_study_id