Trial Outcomes & Findings for Mechanisms of Fall Resistance to Diverse Slipping Conditions (NCT NCT03758040)

Last Updated: 2025-07-04

Results Overview

Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.

Recruitment status

COMPLETED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

Up to 4 hours

Results posted on

2025-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	Slips on Turns Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.	Slips on Slopes Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips were administered to the uphill or downhill foot. Slips on Slopes: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the Computer Assisted Rehabilitation Environment (CAREN) system treadmill.
Overall Study STARTED	21	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanisms of Fall Resistance to Diverse Slipping Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slips on Turns n=21 Participants Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.	Slips on Slopes n=21 Participants Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips were administered to the uphill or downhill foot. Slips on Slopes: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	1.72 meters STANDARD_DEVIATION 0.12 • n=5 Participants	1.73 meters STANDARD_DEVIATION 0.08 • n=7 Participants	1.72 meters STANDARD_DEVIATION 0.10 • n=5 Participants
Weight	71.72 kilograms STANDARD_DEVIATION 18.17 • n=5 Participants	72.90 kilograms STANDARD_DEVIATION 12.80 • n=7 Participants	72.36 kilograms STANDARD_DEVIATION 15.26 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 hours

Population: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.

Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.

Outcome measures

Outcome measures
Measure	Slips on Turns n=378 Trials Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.
Fall Rates - Slips on Turns Fall Rate, Straight Walking	0 Percent of trials resulting in falls.
Fall Rates - Slips on Turns Fall Rate, Curved Walking (2 meter radius), slip administered to the inside foot	7.94 Percent of trials resulting in falls.
Fall Rates - Slips on Turns Fall Rate, Curved Walking (2 meter radius), slip administered to the outside foot	1.59 Percent of trials resulting in falls.
Fall Rates - Slips on Turns Fall Rate, Curved Walking (1 meter radius), slip administered to the inside foot	23.44 Percent of trials resulting in falls.
Fall Rates - Slips on Turns Fall Rate, Curved Walking (1 meter radius), slip administered to the outside foot	3.13 Percent of trials resulting in falls.

PRIMARY outcome

Timeframe: Up to 4 hours

Population: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill.

Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.

Outcome measures

Outcome measures
Measure	Slips on Turns n=567 Trials Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.
Fall Rates - Slips on Slopes Fall Rate, Level Walking	6.35 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (5 degrees), Uphill Slope	6.35 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (10 degrees), Uphill Slope	50.79 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (5 degrees), Downhill Slope	7.94 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (10 degrees), Downhill Slope	44.44 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (5 degrees), Cross-Slope	9.60 Percent of trials resulting in falls.
Fall Rates - Slips on Slopes Fall Rate, Sloped Walking (10 degrees), Cross-Slope	44.00 Percent of trials resulting in falls.

Adverse Events

Slips on Turns

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Slips on Slopes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nathaniel Hunt

University of Nebraska Omaha

Phone: 402-554-4195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place