Clinical trial NCT05144113: FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise
Official title: FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paralysis, Legs
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 subjects, male and female, 18 years and older with lower-limb paralysis who use a wheelchair as their primary means of mobility. Ten subjects will be current FES-rowing participants (especially those doing FES-rowing at home) and 10 subjects will be non-participants.

Brief summary: Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. Despite the success of the FES-rowing Program at Spaulding, FES-rowing systems have not yet evolved beyond research prototypes, and ours is the only program in the US where FES-rowing is available. A new design is critically needed to enable people with paralysis to participate in FES rowing in their own homes, which we believe will maximize both the health and commercial impacts of FES-rowing.

Detailed description: The purpose of this observational study is to gain insights into user needs, and market perception of physical activity and FES-rowing to further develop a new, home-based FES-rowing system that meets the needs of people with paralysis. We will enroll a total of 20 subjects, male and female, 18 years and older with lower-limb paralysis who use a wheelchair as their primary means of mobility. Ten subjects will be current FES-rowing participants (especially those doing FES-rowing at home) and 10 subjects will be non-participants. To determine user needs we will survey prospective customers to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing.

Questionnaires:

Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal and interpersonal domains.

Physical Activity and Disability Survey (PADS): measures physical activity for people with chronic neurological conditions.

Demographic and Mobility Questionnaire: Important information to inform on user and design needs and potential market for at home FES-row system.

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)-(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program.

Eligibility criteria: * male and female,
* 18 years of age and older
* lower-limb paralysis who use a wheelchair as their primary means of mobility.

Exclusion Criteria:

* Under 18 years of age
* no lower-limb paralysis
* People who do not use a wheelchair as their primary means of mobility

Primary outcomes:
measure: Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)
timeFrame: baseline
measure: Barriers to Physical Activity and Disability Survey (BPAD-S)
timeFrame: baseline
measure: Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis
timeFrame: baseline
measure: Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used
timeFrame: baseline
measure: Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Hospital Cambridge
state: Massachusetts
Study officials:
References: