Trial Outcomes & Findings for Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation (NCT NCT03649217)

NCT ID: NCT03649217

Last Updated: 2022-02-03

Results Overview

This test is to also help determine gait velocity/speed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Difference between baseline assessment at start and one week post
• Results posted on: 2022-02-03

Participant Flow

Participant milestones

Measure	Wearing the iStride Device The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Wearing the iStride Device The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
Overall Study subject had severe ataxia not initially found	1
Overall Study subject had cognitive issues not initially found	1

Baseline Characteristics

Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation

Baseline characteristics by cohort

Measure	Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
Age, Continuous	55.67 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	11 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	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Difference between baseline assessment at start and one week post

This test is to also help determine gait velocity/speed.

Outcome measures

Measure

Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Change in Ten Minute Walk Test (10MWT)

0.551 meters per second (m/s) Standard Deviation 0.245

PRIMARY outcome

Timeframe: Difference between baseline assessment at start and one week post

This will provide a clinical assessment on gait speed/velocity. This also requires both static and dynamic balance as the participant will rise from a chair and sit down in a chair when the complete the test. The TUG test provides us different score assessments to help determine if a patient can, for example, cross a crosswalk safely.

Outcome measures

Measure

Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Change in Timed up and Go (TUG)

19.2 seconds Standard Deviation 8.06

SECONDARY outcome

Timeframe: Difference between baseline assessment at start and one week post

This will provide a clinical assessment on balance using the total Berg Balance Scale. Scores range from 0 (least balance) to 56 (best balance).

Outcome measures

Measure

Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Change in Berg Balance Scale

43.52 scores on a scale Standard Deviation 6.41

SECONDARY outcome

Timeframe: Difference between baseline assessment at start and one week post

The FGA measures both balance and walking ability with scores ranging from 0 (least ability) to 30 (highest ability).

Outcome measures

Measure

Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Change in Functional Gait Assessment (FGA)

15 scores on a scale Standard Deviation 4.89

SECONDARY outcome

Timeframe: Difference between baseline assessment at start and one week post

Stroke Specific Quality of Life will collect data on the psychosocial aspect of improvement to help look at the overall quality of life. The total score ranges from 49 to 245, with higher scores indicating a better quality of life.

Outcome measures

Measure

Wearing the iStride Device n=21 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Change in Stroke Specific Quality of Life

165.05 scores on a scale Standard Deviation 23.84

Adverse Events

Wearing the iStride Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Wearing the iStride Device n=21 participants at risk The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their non-paretic foot. There will also be five follow up visits following the final testing session: one-week, one-month, three-months, six-months, and twelve-months Wearing the iStride device: The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.

Psychiatric disorders fall

4.8% 1/21 • Number of events 21 • six months

Additional Information

Brianne Darcy

Moterum Technologies, Inc.

Phone: (864) 659-3180

Email: brie@moterumtechnologies.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place