Trial Outcomes & Findings for Walk Assist Device to Improve Community Ambulation (NCT NCT03222505)

Results Overview

The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Day 1

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Start With Device ON Participants in this arm first completed testing with the device on, then repeated the testing a week later with the device turned off.	Start With Device OFF Participants in this arm first completed testing with the device off, then repeated the testing a week later with the device turned on.
Overall Study STARTED	5	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	0	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	Start With Device ON n=5 Participants Participants in this arm first completed testing with the device on, then repeated the testing a week later with the device turned off.	Start With Device OFF n=7 Participants Participants in this arm first completed testing with the device off, then repeated the testing a week later with the device turned on.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=12 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 8.2 • n=5 Participants	59.9 years STANDARD_DEVIATION 6.3 • n=7 Participants	57.8 years STANDARD_DEVIATION 7.2 • n=12 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=12 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=12 Participants
Self-Selected Walking Speed less than 0.8 m/s	0.57 meters per second STANDARD_DEVIATION 0.21 • n=5 Participants	0.62 meters per second STANDARD_DEVIATION 0.17 • n=7 Participants	0.60 meters per second STANDARD_DEVIATION 0.18 • n=12 Participants

PRIMARY outcome

Timeframe: Day 1

The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."

Outcome measures

Outcome measures
Measure	Device ON n=12 Participants Data collected from while the device was turned on.	Device OFF n=12 Participants Data collected from while the device was turned off.
Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled	837.1 feet Standard Deviation 342.2	804.8 feet Standard Deviation 358.5

PRIMARY outcome

Timeframe: Day 1

Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).

Outcome measures

Outcome measures
Measure	Device ON n=12 Participants Data collected from while the device was turned on.	Device OFF n=12 Participants Data collected from while the device was turned off.
Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed	0.95 meters per second Standard Deviation 0.28	0.84 meters per second Standard Deviation 0.30

SECONDARY outcome

Timeframe: Day 1

Population: Device ON and Device OFF arms were combined as the interest of this metric was the change in excitability between device on and device off conditions within a participant.

TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.

Outcome measures

Outcome measures
Measure	Device ON n=12 Participants Data collected from while the device was turned on.	Device OFF Data collected from while the device was turned off.
Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF	19.02 percent change Standard Deviation 34.5	—

SECONDARY outcome

Timeframe: Day 1

Population: Device ON and Device OFF arms were combined as the interest of this metric was the change in excitability between device on and device off conditions within a participant.

TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.

Outcome measures

Outcome measures
Measure	Device ON n=12 Participants Data collected from while the device was turned on.	Device OFF Data collected from while the device was turned off.
Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF	-13.53 percent change Standard Deviation 31.6	—

Adverse Events

Device ON

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Device OFF

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

Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes

Rehabilitation Institute of Chicago

Phone: 3122386875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place