Trial Outcomes & Findings for Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton (NCT NCT03828214)

Last Updated: 2023-03-07

Results Overview

Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (\~40 markers) applied bilaterally.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.

Results posted on

2023-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Walking In this study a single group of participants were observed in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walking n=11 Participants In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=11 Participants
Age, Categorical >=65 years	7 Participants n=11 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 12.7 • n=11 Participants
Sex: Female, Male Female	6 Participants n=11 Participants
Sex: Female, Male Male	5 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants
Height	163 cm STANDARD_DEVIATION 9.4 • n=11 Participants
weight	81 kg STANDARD_DEVIATION 22.2 • n=11 Participants
Stroke affected side was left	9 Participants n=11 Participants
Time post stroke	7.3 months STANDARD_DEVIATION 4 • n=11 Participants
Fugl-meyer Assessment	30.5 units on a scale STANDARD_DEVIATION 1.5 • n=11 Participants
Montreal Cognitive Assessment (MoCA)	22.4 units on a scale STANDARD_DEVIATION 4.3 • n=11 Participants
Activities Specific Balance Confidence Scale	72.9 units on a scale STANDARD_DEVIATION 20.2 • n=11 Participants
Steps per day	2783 steps STANDARD_DEVIATION 1512 • n=11 Participants

PRIMARY outcome

Timeframe: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.

Population: For one participant data was not available for the C3 condition

Outcome measures

Outcome measures
Measure	Walking n=10 Participants In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Gait Kinematics C1	55.9 degrees Standard Deviation 12.3
Gait Kinematics C2	57.8 degrees Standard Deviation 12.4
Gait Kinematics C3	58.3 degrees Standard Deviation 8.1
Gait Kinematics C4	56.6 degrees Standard Deviation 12.6

SECONDARY outcome

Timeframe: Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.

Population: There was a single group that participated in this within subject design study, here we compare the outcome parameter across the four conditions for this group.

Average max EMG of affected tibialis anterior muscle measured during swing phase for walking conditions using Delsys Tringo EMG sensors. Sample rate 2000Hz.

Outcome measures

Outcome measures
Measure	Walking n=10 Participants In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Lower Limb Electromyography (EMG) C3	0.101 mV Standard Deviation 0.064
Lower Limb Electromyography (EMG) C1	0.115 mV Standard Deviation 0.080
Lower Limb Electromyography (EMG) C2	0.115 mV Standard Deviation 0.077
Lower Limb Electromyography (EMG) C4	0.119 mV Standard Deviation 0.077

SECONDARY outcome

Timeframe: Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.

Population: n=9 for grf data 1 participant No HWA condition secondary to device slipping, 1 participant no clean force plate hits due to short step length.

2 Force platforms were used to quantify ground reaction forces at terminal stance for the affected lower limbs during gait. Sample rate 1200Hz.

Outcome measures

Outcome measures
Measure	Walking n=9 Participants In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Ground Reaction Force at Terminal Stance C1	103 percentage of body weight Standard Deviation 16
Ground Reaction Force at Terminal Stance C2	105 percentage of body weight Standard Deviation 9
Ground Reaction Force at Terminal Stance C3	104 percentage of body weight Standard Deviation 9
Ground Reaction Force at Terminal Stance C4	105 percentage of body weight Standard Deviation 10

SECONDARY outcome

Timeframe: Stairs will be measured at a single time point (in one 2-hour session) for each participant

A timed test of the ability to ascend and descend stairs with our without a rail. For this study a flight of 7 stairs will be used. The means of two trials of ascending and descending will be recorded. (Flansbjer et al., 2005)

Outcome measures

Outcome measures
Measure	Walking n=11 Participants In this study a single group of participants were studied during one session in each of 4 conditions: control walking (CI), HWA walking (C2), Aftereffect (C3), and Late aftereffect (C4)
Stair Climbing Ascend/Descend Test ascend (control)	7.03 seconds Interval 4.2 to 11.0
Stair Climbing Ascend/Descend Test decend (control)	7.61 seconds Interval 4.0 to 10.5
Stair Climbing Ascend/Descend Test ascend with HWA	7.10 seconds Interval 4.0 to 11.0
Stair Climbing Ascend/Descend Test descend with HWA	7.99 seconds Interval 4.1 to 9.5

Adverse Events

Walking

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. Alexandra Borstad

College of St. Scholastica

Phone: 614-395-1708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER