StrokeNCT07759063
Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations
A study testing Walking on self-pacing treadmill and Walking on fixed-pacing treadmill in people with Stroke and Traumatic Brain Injury, run by Quality Living, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is: How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Stroke, Traumatic Brain Injury
- What is being tested?
- Walking on self-pacing treadmill and Walking on fixed-pacing treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current client of Quality Living, Inc., in Omaha, NE
- 19 to 75 years of age
- Speak and understand English
- Can ambulate overground for at least 10 minutes with or without use of aids
- Medically cleared for treadmill exercise
- Hemiparesis secondary to stroke or traumatic brain injury
Who cannot join
- Has not retained power of attorney for healthcare
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is:
- How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in comparison to walking on a treadmill without self-pacing capability? Researchers will compare study participants to themselves when walking on a self-pacing treadmill compared to walking on a fixed-pacing treadmill to see if a difference exists in the equalization of left- and right-sided stride length.
Participants will walk for two minutes at a self-selected pace to warm up and establish a baseline walking speed. They will then walk for 1 - 3 minutes either on a self-pacing treadmill or a fixed-pacing treadmill. A 3-minute seated rest break will follow. Then participants will walk for another 1 - 3 minutes using the treadmill not used in the first walking trial.
Read the detailed description
The chosen treadmill has self-pacing algorithms installed that adjust speed as a person walks. This allows a person to increase or decrease speed as desired throughout a walking session. Researchers have not yet determined the effect of using a self-pacing treadmill on left-right gait equalization among people with acquired hemiparesis secondary to stroke or traumatic brain injury. The researchers will compare measurement data captured by the system software when participants walk on the treadmill with the self-pacing feature turned on versus off. Each walking trial will last 1 - 3 minutes and will occur in a random order during a single research session. The randomization is to ensure that fatigue is not a factor when interpreting results.
- Conditions
- Stroke, Traumatic Brain Injury
- Being tested
- Walking on self-pacing treadmill, Walking on fixed-pacing treadmill
- Keywords
- gait, hemiparesis, physical therapy, walking
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking on self-pacing treadmillBehavioural
Contrast with walking on fixed-pacing treadmill.
Walking on fixed-pacing treadmillBehavioural
Contrast with walking on self-pacing treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Self-pacing treadmill walking first, then fixed-pacing treadmill walking | Experimental | Not described Receives: Behavioral: Walking on self-pacing treadmill; Behavioral: Walking on fixed-pacing treadmill |
| Fixed-pacing treadmill walking first, then self-pacing treadmill walking | Experimental | Not described Receives: Behavioral: Walking on self-pacing treadmill; Behavioral: Walking on fixed-pacing treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking
Non-hemiparetic side step length minus hemiparetic side step length when walking on self-pacing versus fixed pacing treadmill.
Measured: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.
Difference in step-length on hemiparetic and non-hemiparetic sides
Length of forward movement of each foot during each walking step as measured in centimeters.
Measured: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Hux, Ph.D., Quality Living, Inc.
- Investigators
- Karen Hux, Ph.D., Study director, Quality Living, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759063
- Sponsor's protocol ID
- Impower Tread Mill Validation
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available in deidentified form from the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations
- ClinicalTrials.gov ID
- NCT07759063
- Acronym / sponsor ID
- Impower Tread Mill Validation
- Conditions
- Stroke, Traumatic Brain Injury
- Keywords
- gait, hemiparesis, physical therapy, walking
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is:
- How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in comparison to walking on a treadmill without self-pacing capability? Researchers will compare study participants to themselves when walking on a self-pacing treadmill compared to walking on a fixed-pacing treadmill to see if a difference exists in the equalization of left- and right-sided stride length.
Participants will walk for two minutes at a self-selected pace to warm up and establish a baseline walking speed. They will then walk for 1 - 3 minutes either on a self-pacing treadmill or a fixed-pacing treadmill. A 3-minute seated rest break will follow. Then participants will walk for another 1 - 3 minutes using the treadmill not used in the first walking trial.
Detailed description
The chosen treadmill has self-pacing algorithms installed that adjust speed as a person walks. This allows a person to increase or decrease speed as desired throughout a walking session. Researchers have not yet determined the effect of using a self-pacing treadmill on left-right gait equalization among people with acquired hemiparesis secondary to stroke or traumatic brain injury. The researchers will compare measurement data captured by the system software when participants walk on the treadmill with the self-pacing feature turned on versus off. Each walking trial will last 1 - 3 minutes and will occur in a random order during a single research session. The randomization is to ensure that fatigue is not a factor when interpreting results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-pacing treadmill walking first, then fixed-pacing treadmill walking | Experimental | Behavioral: Walking on self-pacing treadmill, Behavioral: Walking on fixed-pacing treadmill |
| Fixed-pacing treadmill walking first, then self-pacing treadmill walking | Experimental | Behavioral: Walking on self-pacing treadmill, Behavioral: Walking on fixed-pacing treadmill |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current client of Quality Living, Inc., in Omaha, NE
- 19 to 75 years of age
- Speak and understand English
- Can ambulate overground for at least 10 minutes with or without use of aids
- Medically cleared for treadmill exercise
Key exclusion criteria (1 listed)
- Has not retained power of attorney for healthcare
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking on self-pacing treadmillContrast with walking on fixed-pacing treadmill. | Behavioural | Fixed-pacing treadmill walking first, then self-pacing treadmill walking, Self-pacing treadmill walking first, then fixed-pacing treadmill walking |
| Walking on fixed-pacing treadmillContrast with walking on self-pacing treadmill. | Behavioural | Fixed-pacing treadmill walking first, then self-pacing treadmill walking, Self-pacing treadmill walking first, then fixed-pacing treadmill walking |
Primary outcome
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking
Time frame: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.
Non-hemiparetic side step length minus hemiparetic side step length when walking on self-pacing versus fixed pacing treadmill.
Difference in step-length on hemiparetic and non-hemiparetic sides
Time frame: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill.
Length of forward movement of each foot during each walking step as measured in centimeters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be available in deidentified form from the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Hux, Ph.D. study director
Quality Living, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking on self-pacing treadmill and Walking on fixed-pacing treadmill in people with Stroke and Traumatic Brain Injury, run by Quality Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking (time frame: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.