Trial Outcomes & Findings for Powered Hip Exoskeleton Assistance Study (NCT NCT03924752)

Last Updated: 2022-02-08

Results Overview

Measure Description: The subject's preferred overground walking speed while wearing a powered hip exoskeleton was recorded. During walking, the exoskeleton provided hip assistance. There was a total of five walking conditions that were evaluated: 1) level-ground, 2) ramp ascent, 3) ramp descent, 4) stair ascent and 5) stair descent. The ramp incline was set to 9.2 degrees and the stair height was set to 15.24 cm. The user's preferred walking speed was calculated by looking at the distance traveled divided by time for a given walking condition. The distance was fixed and a completion time for each trial was recorded with a computer timer to calculate the average walking velocity for a given trial.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

4 hours

Results posted on

2022-02-08

Participant Flow

Healthy and young individuals were recruited between February 2021 to March 2021. The first participant was enrolled on February 2021 and the last participant was enrolled on March 2021.

Participant milestones

Participant milestones
Measure	Healthy Individuals Using a Powered Hip Exoskeleton This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures). Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Powered Hip Exoskeleton Assistance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Individuals Using a Powered Hip Exoskeleton n=10 Participants This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures). Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	22.5 years STANDARD_DEVIATION 3.1 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants
Height	174.06 centimeters STANDARD_DEVIATION 6.35 • n=93 Participants
weight	69.8 kilograms STANDARD_DEVIATION 8.1 • n=93 Participants
Self-Selected Walking Speed Level-Ground	1.08 meters per second STANDARD_DEVIATION 0.14 • n=93 Participants
Self-Selected Walking Speed Ramp Ascent	1.31 meters per second STANDARD_DEVIATION 0.06 • n=93 Participants
Self-Selected Walking Speed Ramp Descent	1.27 meters per second STANDARD_DEVIATION 0.17 • n=93 Participants
Self-Selected Walking Speed Stair Ascent	0.62 meters per second STANDARD_DEVIATION 0.07 • n=93 Participants
Self-Selected Walking Speed Stair Descent	0.69 meters per second STANDARD_DEVIATION 0.06 • n=93 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: The effect of hip exoskeleton assistance on the subject's preferred overground walking speed across different locomotion modes was evaluated. Five walking conditions were 1) level-ground, 2) ramp ascent, 3) ramp descent, 4) stair ascent, and 5) stair descent. The ramp incline was set to 9.2 degrees and stair height was set to15.24 cm. During walking, the exoskeleton provided assistance relevant to the user's biological demand (hip flexion and extension assistance).

Outcome measures

Outcome measures
Measure	Healthy Individuals Using a Powered Hip Exoskeleton n=10 Participants This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject was tested with each condition of the exoskeleton (repeated measures). Powered hip exoskeleton: The study team tested a powered hip exoskeleton and its capability to improve locomotion.
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes Level-Ground Assistance	1.14 meters per second Standard Deviation 0.08
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes Ramp Ascent Assistance	1.26 meters per second Standard Deviation 0.08
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes Ramp Descent Assistance	1.26 meters per second Standard Deviation 0.15
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes Stair Ascent Assistance	0.61 meters per second Standard Deviation 0.05
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes Stair Descent Assistance	0.71 meters per second Standard Deviation 0.07

Adverse Events

Healthy Individuals Using a Powered Hip Exoskeleton

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

Dr. Aaron Young

Georgia Institute of Technology

Phone: 404-385-5306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place