Cubii Vital Sign and Range of Motion Study

NCT06537635 | Completed FDA Device

• 1 other identifier: CubiiPro
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of a seated compact elliptical on vital signs and range of motion (of knees and ankles) following thirty minutes of activity.

Conditions

Effects of; Exertion

Keywords

compact elliptical; range of motion; aerobic exercise

Outcome Measures

Primary Outcomes (4)

• Overall Satisfaction

  The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

  After the 30-minute treatment (T4)

• Ease of Use

  The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

  After the 30-minute treatment (T4)

• Refer a friend

  The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

  After the 30-minute treatment (T4)

• Knee Flexion Baseline

  Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer.

  This information was collected after the 30-minute treatment (T4).

Study Arms (1)

30-minute session of exercise using a seated compact elliptical trainer

EXPERIMENTAL

Device: Cubii seated compact elliptical trainer

Interventions

Cubii seated compact elliptical trainer DEVICE

The Cubii® Pro is an under-desk seated elliptical trainer. This device provides 8 levels of resistance and documents the total number of strides, distance covered in miles, and calories expended during an activity session.

30-minute session of exercise using a seated compact elliptical trainer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently engage in a program or aerobic exercise greater than 90 minutes per week
• report no previously diagnosed chronic health problems
• patient population of Kaizo Health
• perform all study procedures in order to participate

You may not qualify if:

• less than 18 years of age
• pregnancy
• cancer
• any of the conditions on the ACSM absolute and relative contraindications to exercise

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (1)

Sport and Spine Rehab

Rockville, Maryland, 20852, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: August 5, 2024
• Study Start: November 18, 2019
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)