Trial Outcomes & Findings for Assistive Hip Exoskeleton Study for Stroke (NCT NCT03924765)

Last Updated: 2021-12-15

Results Overview

Using five different hip exoskeleton assistance strategies, the participant's overground self-selected walking speed was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more. For example, bilateral additional paretic assistance means that the exoskeleton is providing assistance to both hip joints but provides higher magnitude on the paretic side.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

4 hours

Results posted on

2021-12-15

Participant Flow

Participants were recruited based on clinician referral between July 2019 to November 2020. The first participant was enrolled on July 2019 and the last participant was enrolled on November 2020.

The robotic hip exoskeleton device that was used for the study has a limited capability in accommodating the participant's body size. While the study team recruited subjects that had a body size within the range that the device can accommodate, 5 participants had different body curvature (e.g., pelvis shape) that was not ideal for the device to provide accurate assistance.

Participant milestones

Participant milestones
Measure	Individuals Post-stroke Using a Powered Hip Exoskeleton This study was conducted on a sample population of stroke 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 in stroke survivors.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assistive Hip Exoskeleton Study for Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individuals Post-stroke Using a Powered Hip Exoskeleton n=5 Participants This study was conducted on a sample population of stroke 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 in stroke survivors.
Time Since Stroke	63.6 months STANDARD_DEVIATION 28.3 • n=5 Participants
Right Paretic Side	3 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Height	172.5 Centimeters STANDARD_DEVIATION 9.8 • n=5 Participants
Weight	74.5 kilograms STANDARD_DEVIATION 13 • n=5 Participants
Usage of Assistive Device	3 Participants n=5 Participants
Overground Self-Selected Walking Speed	80.08 centimeters per second STANDARD_DEVIATION 17.78 • n=5 Participants
Step Length Asymmetry	0.53 unitless STANDARD_DEVIATION 0.02 • n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: The effect of different exoskeleton strategies on the subject was evaluated by calculating the changes in overground walking speed by comparing them to the subject's baseline of not wearing the exoskeleton (within subject analysis).

Outcome measures

Outcome measures
Measure	Individuals Post-stroke Using a Powered Hip Exoskeleton n=5 Participants This study was conducted on a sample population of stroke 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 in stroke survivors.
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance Unilateral Paretic Assistance	87.03 centimeters per second Standard Deviation 12.94
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance Unilateral Non-Paretic Assistance	87.96 centimeters per second Standard Deviation 14.8
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance Bilateral Equal Assistance	90.4 centimeters per second Standard Deviation 14.2
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance Bilateral Additional Paretic Assistance	93.05 centimeters per second Standard Deviation 14.64
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance Bilateral Additional Non-Paretic Assistance	94.64 centimeters per second Standard Deviation 15.69

SECONDARY outcome

Timeframe: 4 hours

Population: The effect of different exoskeleton strategies on the subject was evaluated by calculating the changes in step length asymmetry by comparing them to the subject's baseline of not wearing the exoskeleton (within subject analysis).

Step length asymmetry was calculated by dividing the paretic side step length by the sum of the paretic and non-paretic side step lengths, where an asymmetry of 0.5 indicates perfect symmetry between the paretic and non-paretic sides. Using five different hip exoskeleton assistance strategies, the participant's Step Length Asymmetry during overground walking was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more.

Outcome measures

Outcome measures
Measure	Individuals Post-stroke Using a Powered Hip Exoskeleton n=5 Participants This study was conducted on a sample population of stroke 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 in stroke survivors.
Step Length Asymmetry Using Hip Exoskeleton Assistance Unilateral Paretic Assistance	0.54 unitless Standard Deviation 0.02
Step Length Asymmetry Using Hip Exoskeleton Assistance Unilateral Non-Paretic Assistance	0.54 unitless Standard Deviation 0.03
Step Length Asymmetry Using Hip Exoskeleton Assistance Bilateral Equal Assistance	0.54 unitless Standard Deviation 0.02
Step Length Asymmetry Using Hip Exoskeleton Assistance Bilateral Additional Paretic Assistance	0.54 unitless Standard Deviation 0.02
Step Length Asymmetry Using Hip Exoskeleton Assistance Bilateral Additional Non-Paretic Assistance	0.53 unitless Standard Deviation 0.02

Adverse Events

Individuals Post-stroke 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