Optimization of Adaptive Rowing Seating

NCT ID: NCT07099625

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-06
• Study Completion Date: 2028-09-30

Brief 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. 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:

1) 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AIRS V2

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.

Group Type: EXPERIMENTAL

Adaptive Indoor Rowing Seat

Intervention Type: DEVICE

Light weight adjustable indoor rowing seat for Veterans with limited trunk stability.

Paddle Sport Adaptive Seating System

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.

Group Type: EXPERIMENTAL

Paddle Sport adaptive seating system

Intervention Type: DEVICE

On market comparator (discontinued) adaptive indoor rowing seat for individuals with limited trunk stability.

Interventions

Adaptive Indoor Rowing Seat

Light weight adjustable indoor rowing seat for Veterans with limited trunk stability.

Intervention Type: DEVICE

Paddle Sport adaptive seating system

On market comparator (discontinued) adaptive indoor rowing seat for individuals with limited trunk stability.

Intervention Type: DEVICE

Other Intervention Names

AIRS V2

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Louis Stokes VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Looft, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Countries

United States

Central Contacts

John M Looft, PhD

Role: CONTACT

john.looft@va.gov

(612) 725-2001

John L Belew, PhD

Role: CONTACT

John.Belew@va.gov

(612) 467-4806

Facility Contacts

Nicole Walker, MS

Role: primary

nicole.walker6@va.gov

612-467-3229

Julie Toth, RN

Role: backup

Julie.Toth@va.gov

(612) 467-5655 ext. 5655

Lisa Lombardo, MPT

Role: primary

Lisa.Lombardo2@va.gov

216-402-0190

Maura Malencheck

Role: backup

Maura.Malenchek@va.gov

2162930762

Other Identifiers

RRD5-015-24W

Identifier Type: -

Identifier Source: org_study_id