Peripheral Arterial DiseaseNCT03891641
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
A study testing Treadwell Tredlr in people with Peripheral Arterial Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Treadwell Tredlr
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be able to walk without an assistive aid (i.e., walker, cane)
- Have the capacity the provide written informed consent
- Have previously diagnosed peripheral arterial disease (by self-report)
Who cannot join
- Lower extremity injury or fracture within the last 6 months
- Have a leg prosthesis
- Prisoners
- Individuals clearly lacking the capacity to provide informed consent
- Vestibular impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Biomechanics Laboratory
Chapel Hill, North Carolina, 27514
About this study
Official title: A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Treadwell Tredlr
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadwell TredlrBehavioural
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treadling Group | Experimental | Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. Receives: Behavioral: Treadwell Tredlr |
| Control Group | No intervention | Control Subjects continue their normal daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overground Walking Speed After Intervention
Measured from the time taken to walk 6 meters.
Measured: Baseline, 6 weeks
Change in 6-min Walk Distance
Measured from the distance walked in 6 minutes.
Measured: Baseline, 6 weeks
Secondary outcomes (2)
Change in Stride Length
Measured using motion capture as the distance between heel markers across successive steps.
Measured: Baseline, 6 weeks
Change in Peak Ankle Power
Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jun 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Why it stopped: COVID-19 continues to prevent recruitment of people over the age of 65 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Treadwell Therapeutics, Inc
- Responsible party
- Sponsor
- Investigators
- Jason Franz, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891641
- Sponsor's protocol ID
- 18-3169
- Status last verified
- Aug 2020
- First submitted
- 25 Mar 2019
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03891641
- Acronym / sponsor ID
- 18-3169
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 continues to prevent recruitment of people over the age of 65 years.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Treadwell Therapeutics, Inc
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.
| Arm | Type | Receives |
|---|---|---|
| Treadling Group | Experimental | Behavioral: Treadwell TredlrTreadling subjects will do so 3x per week (15 min sessions) for 6 weeks. |
| Control Group | No intervention | –Control Subjects continue their normal daily activities. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Be able to walk without an assistive aid (i.e., walker, cane)
- Have the capacity the provide written informed consent
- Have previously diagnosed peripheral arterial disease (by self-report)
Key exclusion criteria (5 listed)
- Lower extremity injury or fracture within the last 6 months
- Have a leg prosthesis
- Prisoners
- Individuals clearly lacking the capacity to provide informed consent
- Vestibular impairment
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 |
|---|---|---|
| Treadwell TredlrComplete treadling exercise 3x per week (15 min sessions) for 6 weeks. | Behavioural | Treadling Group |
Primary outcome
Change in Overground Walking Speed After Intervention
Time frame: Baseline, 6 weeks
Measured from the time taken to walk 6 meters.
Change in 6-min Walk Distance
Time frame: Baseline, 6 weeks
Measured from the distance walked in 6 minutes.
2 secondary outcomes
Change in Stride Length
Time frame: Baseline, 6 weeks
Change in Peak Ankle Power
Time frame: Baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
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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. This study is not recruiting at the moment.
Jason Franz, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadwell Tredlr in people with Peripheral Arterial Disease, run by University of North Carolina, Chapel Hill 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Overground Walking Speed After Intervention (time frame: Baseline, 6 weeks). 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 2 Nov 2020.