Optimization of Adaptive Rowing Seating

NCT07099625 | Not Yet Recruiting FDA Device

• 1 other identifier: RRD5-015-24W
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  up to 4 weeks after enrollment

• Custom Usability Items

  Questions study specific to the usability of the indoor rowing seats

  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.

  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."

  up to 4 weeks after enrollment

• Usability Metric for User Experience [(Finstad et al 2010)]

  Usability experience survey

  up to 4 weeks after enrollment

Study Arms (2)

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.

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.

Device: Paddle Sport adaptive seating system

Interventions

Adaptive Indoor Rowing Seat DEVICE

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

Also known as: AIRS V2

AIRS V2

Paddle Sport adaptive seating system DEVICE

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

Paddle Sport Adaptive Seating System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Louis Stokes VA Medical Center: collaborator

Study Sites (2)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Neurodegenerative Diseases; Paralysis; Paresis

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John M Looft, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Looft, PhD

CONTACT

(612) 725-2001; john.looft@va.gov

John L Belew, PhD

CONTACT

(612) 467-4806; John.Belew@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Single group assignment with crossover design where participants will be randomized which rowing seat they start with and which seat is second. n=15

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 1, 2025
• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)