Clinical trial NCT03744286: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a 2-visit clinical trial to test a novel prototype slip inducing platform device for feasibility and not health outcomes.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Change in Static Balance
timeFrame: 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)
measure: Change in Dynamic Balance
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: