Spinal Cord DiseasesOARSNCT07099625
Optimization of Adaptive Rowing Seating
A study testing Adaptive Indoor Rowing Seat and Paddle Sport adaptive seating system in people with Spinal Cord Diseases and Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Adaptive sports programs are integral components to combating Veteran isolation, promoting wellbeing and seeking to build teams, networks, communities. These activity-based communities are medicine free treatment systems enhancing Veterans' health from a holistic perspective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Diseases, Spinal Cord Injuries, Neurodegenerative Disorders
- What is being tested?
- Adaptive Indoor Rowing Seat and Paddle Sport adaptive seating system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2026to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-ventilator dependent paralysis, such as:
- central nervous system impairment
- spinal cord injuries with single neurological level in the cervical to lumbosacral region
- cerebrovascular accident with associated sequelae including but not limited to hemiparesis and spasticity
- neurodegenerative disorders including but not limited to amyotrophic lateral sclerosis, multiple sclerosis, multiple system atrophy, and parkinsonism
- Poor trunk control/stability
Show all 9Show fewer
- Ability of body structure to fit within the limits of AIRS and the rowing system
- Either volitional control of lower extremities or response/tolerance to electrical stimulation
- Individuals who would be classified as PR2 or PR1 - FISA Para-Rowing Classifications
Who cannot join
- Veterans will be excluded if they have:
- acute illness or injury
- active or recent pressure injuries in the last 6 months affecting their ability to safely row (e.g., the coccyx, ischial tuberosity, sacrum, etc.)
- Individuals who would be classified as NE or PR3-PD - FISA Para-Rowing Classifications
- Flap procedure to address pressure injury less than one year prior
- Upper extremity pain that restricts rowing
Show all 12Show fewer
- Surgical procedure within past 6 months that would make the study procedures unsafe (e.g., tendon repairs/transfers, neural decompressions, bony fusions, etc.)
- Upper extremity or spine fractures within past 3 months, or longer if remains unstable/not fully healed.
- Medical conditions such as cardiovascular disease, pulmonary disease, or other conditions that would make the study procedures unsafe pregnancy
- Inability to communicate with the study team in real time
- Inability to follow simple commands
- Unable or unwilling to give consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Lisa Lombardo, MPT, 216-402-0190, Lisa.Lombardo2@va.gov
Maura Malencheck, 2162930762, Maura.Malenchek@va.gov
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Nicole Walker, MS, (612) 467-3229, nicole.walker6@va.gov
Julie Toth, RN, (612) 467-5655 ext. 5655, Julie.Toth@va.gov
About this study
Official title: Optimization of Adaptive Rowing Seating (OARS)
Adaptive sports programs are integral components to combating Veteran isolation, promoting wellbeing and seeking to build teams, networks, communities. These activity-based communities are medicine free treatment systems enhancing Veterans' health from a holistic perspective. This approach to Veteran healthcare is critical as studies indicate Veterans not only have 56% higher perceived social isolation but are also 1.5x more susceptible to suicide than the general public. It is imperative to improve access to exercise and physical activity through adaptive sport or recreation. This proposal is going to focus on Adaptive Indoor Rowing for Veterans with limited or changing trunk stability (i.e. SCI/D, paralysis, paresis, etc.). Rowing is a unique full-body activity that increases cardiovascular demand and increases coordination and aerobic capacity through movement. This proposal aims to address critical gaps in adaptive rowing technology and provide Veterans with limited trunk stability access to full stroke adaptive rowing.
Read the detailed description
Significance to VA: Veterans with SCI/D experience limited access to physical activity due to insufficient adaptive equipment options. It is imperative to improve access to exercise and physical activity through the thoughtful design and development of adequate adaptive technologies that reduce barriers to participation. The current state of adaptive indoor rowing is ineffective at exercising the full body, which limits the improvement of cardiovascular health and neuromusculoskeletal coordination resulting in decreased benefits to Veterans and may discourage further motivation to participate. This proposal focuses on Adaptive Rowing for Veterans with limited trunk stability and specifically on the need for new adaptive seat options for indoor rowing
Innovation and Impact: Current adaptations for indoor rowing bypass the use of the legs and reduce participant range of motion, limiting the full-body exercise to an arms-only workout regardless of the user's ability. The proposed adaptive indoor rowing seat provides a full slide motion while also regulating trunk range of motion movements. A function that is currently unavailable in any current or past adaptive indoor rowing seat.
Specific Aims:
- Optimize a new clinically viable adaptive indoor rowing seat for Veterans with limited trunk stability.
Subtask 1) Assess 1st prototype of Adaptive Indoor Rowing Seat (AIRS V1) with Veterans and clinicians specializing in SCI/D and collect feedback.
Subtask 2) Develop 2nd prototype of Adaptive Indoor Rowing Seat (AIRS V2) from Veteran and clinician feedback collected in Subtask 1.
Subtask 3) Test feasibility of 2nd prototype of Adaptive Indoor Rowing Seat (AIRS V2) with Veterans in Cleveland and collect feedback from Veterans and clinicians.
H1) The AIRS V2 will result in increased anterior/posterior trunk movement when compared to the discontinued Paddle Sport adaptive seating system while performing rowing.
H2) Rowing with the AIRS V2 will result in increased stroke length or ability to generate more power through their upper extremities when compared to the discontinued Paddle Sport adaptive seating system.
H3) Veterans will rate feeling more stable and comfortable rowing with the AIRS V2.
Subtask 4) Generate 3rd prototype (AIRS V3) from feedback on AIRS V2. The entirety of feedback collected, and data analyzed will result in the development of two AIRS V3 prototypes.
Methodology: Year one of this proposal will focus on Subtask 1 and 2. First, feedback on the design of AIRS V1 will be collected from Veterans with SCI/D and SCI/D Clinicians at the 2025 National Wheelchair Games being hosted in Minneapolis and the RECOVER and APT Center Veteran Engagement Panels. Feedback will also be obtained from study industry partners: Concept2 and US Rowing. The investigators will then design and fabricate AIRS V2 incorporating the Veterans with SCI/D, SCI/D clinicians, and industry feedback. In year 2, AIRS V2 will be shipped to the APT Center for human subject testing with Veterans with SCI/D. The hypotheses listed above will be tested to access whether AIRS V2 is more effective and preferred than the Paddle Sport adaptive seating system currently being used at the APT Center: Both sites will work together to use the data and feedback from the human subjects testing to guide any additional modifications needed for AIRS V3. In Year 3, the design team will build two AIRS V3s, shipping one to the APT Center, as well as disseminating any remaining findings.
Path to Translation/Implementation: Additionally, the overall experience and insights gained throughout this project will contribute to commercialization opportunities of AIRS V3. Throughout this proposal the investigators will strategize with study industry partners, Concept2 \& US Rowing, along with VA Technology Transfer Program to determine the best commercialization path for getting the AIRS V3 in the hands of Veterans.
- Conditions
- Spinal Cord Diseases, Spinal Cord Injuries, Neurodegenerative Disorders, Cerebrovascular Accident With Associated Sequelae
- Being tested
- Adaptive Indoor Rowing Seat, Paddle Sport adaptive seating system
- Keywords
- Veteran Health, Sports for Persons with Disabilities, Paralysis, Paresis, Adaptive Sports, Indoor Rowing
- Medical subject headings
- Spinal Cord Diseases, Spinal Cord Injuries, Neurodegenerative Diseases, Paralysis, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Indoor Rowing SeatDevice
Also called AIRS V2
Light weight adjustable indoor rowing seat for Veterans with limited trunk stability.
Paddle Sport adaptive seating systemDevice
On market comparator (discontinued) adaptive indoor rowing seat for individuals with limited trunk stability.
| Study group | Role | What they receive |
|---|---|---|
| AIRS V2 | Experimental | The (Adaptive Indoor Rowing Seat) AIRS V2 will be used within an established adaptive rowing protocol for Veterans with limited trunk strength and compared with the Paddle Sport adaptive seating system. Receives: Device: Adaptive Indoor Rowing Seat |
| Paddle Sport Adaptive Seating System | Experimental | The (Adaptive Indoor Rowing Seat) AIRS V2 will be used within an established adaptive rowing protocol for Veterans with limited trunk strength and compared with the Paddle Sport adaptive seating system. Receives: Device: Paddle Sport adaptive seating system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Movement
Changes in angular trunk position (degrees) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Measured: up to 4 weeks after enrollment
Rowing Stroke Length
Changes in stroke length (cm) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Measured: up to 4 weeks after enrollment
Power (Watts)
Changes in power generation (Watts) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Measured: up to 4 weeks after enrollment
Custom Usability Items
Questions study specific to the usability of the indoor rowing seats
Measured: up to 4 weeks after enrollment
System Usability Score (SUS) [Brook (1996, 2013)]
Widely used measure to assess usability of any technological system. It is a questionnaire based approach that combines subjective ratings and objective metrics to provide a quantitative measure of usability.
Measured: up to 4 weeks after enrollment
User Experience Questionnaire (UEQ) [(Laugwitz et al 2006, 2008)]
A quick and comprehensive assessment tool that allows users "in a very simple and immediate way to express feelings, impressions, and attitudes that arise when experiencing the product under investigation."
Measured: up to 4 weeks after enrollment
Usability Metric for User Experience [(Finstad et al 2010)]
Usability experience survey
Measured: up to 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start5 Oct 2026 (estimated)
- Primary completion4 Oct 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Crossover
- Model description
- Single group assignment with crossover design where participants will be randomized which rowing seat they start with and which seat is second. n=15
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Louis Stokes VA Medical Center
- Responsible party
- Sponsor
- Investigators
- John M Looft, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099625
- Sponsor's protocol ID
- RRD5-015-24W
- Acronym
- OARS
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Adaptive Rowing Seating (OARS)
- ClinicalTrials.gov ID
- NCT07099625
- Acronym / sponsor ID
- OARS / RRD5-015-24W
- Conditions
- Spinal Cord Diseases, Spinal Cord Injuries, Neurodegenerative Disorders, Cerebrovascular Accident With Associated Sequelae
- Keywords
- Veteran Health, Sports for Persons with Disabilities, Paralysis, Paresis, Adaptive Sports, Indoor Rowing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Louis Stokes VA Medical Center
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Aug 2025 (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.
Adaptive sports programs are integral components to combating Veteran isolation, promoting wellbeing and seeking to build teams, networks, communities. These activity-based communities are medicine free treatment systems enhancing Veterans' health from a holistic perspective. This approach to Veteran healthcare is critical as studies indicate Veterans not only have 56% higher perceived social isolation but are also 1.5x more susceptible to suicide than the general public. It is imperative to improve access to exercise and physical activity through adaptive sport or recreation. This proposal is going to focus on Adaptive Indoor Rowing for Veterans with limited or changing trunk stability (i.e. SCI/D, paralysis, paresis, etc.). Rowing is a unique full-body activity that increases cardiovascular demand and increases coordination and aerobic capacity through movement. This proposal aims to address critical gaps in adaptive rowing technology and provide Veterans with limited trunk stability access to full stroke adaptive rowing.
Detailed description
Significance to VA: Veterans with SCI/D experience limited access to physical activity due to insufficient adaptive equipment options. It is imperative to improve access to exercise and physical activity through the thoughtful design and development of adequate adaptive technologies that reduce barriers to participation. The current state of adaptive indoor rowing is ineffective at exercising the full body, which limits the improvement of cardiovascular health and neuromusculoskeletal coordination resulting in decreased benefits to Veterans and may discourage further motivation to participate. This proposal focuses on Adaptive Rowing for Veterans with limited trunk stability and specifically on the need for new adaptive seat options for indoor rowing
Innovation and Impact: Current adaptations for indoor rowing bypass the use of the legs and reduce participant range of motion, limiting the full-body exercise to an arms-only workout regardless of the user's ability. The proposed adaptive indoor rowing seat provides a full slide motion while also regulating trunk range of motion movements. A function that is currently unavailable in any current or past adaptive indoor rowing seat.
Specific Aims:
- Optimize a new clinically viable adaptive indoor rowing seat for Veterans with limited trunk stability.
Subtask 1) Assess 1st prototype of Adaptive Indoor Rowing Seat (AIRS V1) with Veterans and clinicians specializing in SCI/D and collect feedback.
Subtask 2) Develop 2nd prototype of Adaptive Indoor Rowing Seat (AIRS V2) from Veteran and clinician feedback collected in Subtask 1.
Subtask 3) Test feasibility of 2nd prototype of Adaptive Indoor Rowing Seat (AIRS V2) with Veterans in Cleveland and collect feedback from Veterans and clinicians.
H1) The AIRS V2 will result in increased anterior/posterior trunk movement when compared to the discontinued Paddle Sport adaptive seating system while performing rowing.
H2) Rowing with the AIRS V2 will result in increased stroke length or ability to generate more power through their upper extremities when compared to the discontinued Paddle Sport adaptive seating system.
H3) Veterans will rate feeling more stable and comfortable rowing with the AIRS V2.
Subtask 4) Generate 3rd prototype (AIRS V3) from feedback on AIRS V2. The entirety of feedback collected, and data analyzed will result in the development of two AIRS V3 prototypes.
Methodology: Year one of this proposal will focus on Subtask 1 and 2. First, feedback on the design of AIRS V1 will be collected from Veterans with SCI/D and SCI/D Clinicians at the 2025 National Wheelchair Games being hosted in Minneapolis and the RECOVER and APT Center Veteran Engagement Panels. Feedback will also be obtained from study industry partners: Concept2 and US Rowing. The investigators will then design and fabricate AIRS V2 incorporating the Veterans with SCI/D, SCI/D clinicians, and industry feedback. In year 2, AIRS V2 will be shipped to the APT Center for human subject testing with Veterans with SCI/D. The hypotheses listed above will be tested to access whether AIRS V2 is more effective and preferred than the Paddle Sport adaptive seating system currently being used at the APT Center: Both sites will work together to use the data and feedback from the human subjects testing to guide any additional modifications needed for AIRS V3. In Year 3, the design team will build two AIRS V3s, shipping one to the APT Center, as well as disseminating any remaining findings.
Path to Translation/Implementation: Additionally, the overall experience and insights gained throughout this project will contribute to commercialization opportunities of AIRS V3. Throughout this proposal the investigators will strategize with study industry partners, Concept2 \& US Rowing, along with VA Technology Transfer Program to determine the best commercialization path for getting the AIRS V3 in the hands of Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single group assignment with crossover design where participants will be randomized which rowing seat they start with and which seat is second. n=15
| Arm | Type | Receives |
|---|---|---|
| AIRS V2 | Experimental | Device: Adaptive Indoor Rowing SeatThe (Adaptive Indoor Rowing Seat) AIRS V2 will be used within an established adaptive rowing protocol for Veterans with limited trunk strength and compared with the Paddle Sport adaptive seating system. |
| Paddle Sport Adaptive Seating System | Experimental | Device: Paddle Sport adaptive seating systemThe (Adaptive Indoor Rowing Seat) AIRS V2 will be used within an established adaptive rowing protocol for Veterans with limited trunk strength and compared with the Paddle Sport adaptive seating system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-ventilator dependent paralysis, such as:
- Poor trunk control/stability
- Ability of body structure to fit within the limits of AIRS and the rowing system
- Either volitional control of lower extremities or response/tolerance to electrical stimulation
- Individuals who would be classified as PR2 or PR1 - FISA Para-Rowing Classifications
Key exclusion criteria (12 listed)
- Veterans will be excluded if they have:
- Individuals who would be classified as NE or PR3-PD - FISA Para-Rowing Classifications
- Flap procedure to address pressure injury less than one year prior
- Upper extremity pain that restricts rowing
- Surgical procedure within past 6 months that would make the study procedures unsafe (e.g., tendon repairs/transfers, neural decompressions, bony fusions, etc.)
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 |
|---|---|---|
| Adaptive Indoor Rowing SeatAlso: AIRS V2Light weight adjustable indoor rowing seat for Veterans with limited trunk stability. | Device | AIRS V2 |
| Paddle Sport adaptive seating systemOn market comparator (discontinued) adaptive indoor rowing seat for individuals with limited trunk stability. | Device | Paddle Sport Adaptive Seating System |
Primary outcome
Trunk Movement
Time frame: up to 4 weeks after enrollment
Changes in angular trunk position (degrees) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Rowing Stroke Length
Time frame: up to 4 weeks after enrollment
Changes in stroke length (cm) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Power (Watts)
Time frame: up to 4 weeks after enrollment
Changes in power generation (Watts) will be captured during a self-selected, moderate pace for 2-5 minutes depending on their ability. They will complete 3 trials of rowing with at least 10 minutes of rest between trials on each seat.
Custom Usability Items
Time frame: up to 4 weeks after enrollment
Questions study specific to the usability of the indoor rowing seats
System Usability Score (SUS) [Brook (1996, 2013)]
Time frame: up to 4 weeks after enrollment
Widely used measure to assess usability of any technological system. It is a questionnaire based approach that combines subjective ratings and objective metrics to provide a quantitative measure of usability.
User Experience Questionnaire (UEQ) [(Laugwitz et al 2006, 2008)]
Time frame: up to 4 weeks after enrollment
A quick and comprehensive assessment tool that allows users "in a very simple and immediate way to express feelings, impressions, and attitudes that arise when experiencing the product under investigation."
Usability Metric for User Experience [(Finstad et al 2010)]
Time frame: up to 4 weeks after enrollment
Usability experience survey
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
John M Looft, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Indoor Rowing Seat and Paddle Sport adaptive seating system in people with Spinal Cord Diseases and Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact John M Looft, PhD ((612) 725-2001, john.looft@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Movement (time frame: up to 4 weeks after enrollment). The study lists 7 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 24 Jul 2026.