Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

April 24, 2024 updated by: James Rimmer, University of Alabama at Birmingham

Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)

The smart trainer ergometer is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals with post-stroke limb impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers. Much of the reason for the low rates of activity among this population comes from the presence of barriers. Lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities. Based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. The smart trainer ergometer (also known as the Advanced Virtual Exercise Environment Device) is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways.

In our previous protocol (IRB-300001384) we explored the power output curves of people post stroke compared with non-impaired individuals during one arm versus two arm cycling exercise using the smart trainer arm ergometer. The work demonstrated the potential benefit of interactive exercise for those with physical disabilities. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals who have a stroke-based limb impairment.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laurie Malone, PhD

Study Contact Backup

  • Name: Sangeetha Padalabalanarayanan

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • WHARF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females post-stroke
  • Age 40-70 years
  • Able to use both arms during arm cycling exercise (i.e., able to complete the 10 revolution pre-test)

Exclusion Criteria:

  • Younger than 40 and older than 70 years
  • No movement in one arm or have an injury that prevents safe use of one arm during exercise
  • Unable to complete the 10 revolution pre-test
  • Unstable cardiovascular conditions
  • Unable to understand study directions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm Ergometer Smart Trainer Cycling
Participants will participate in an 8-week exercise training program using the smart trainer.
Other: Arm ergometer smart trainer cycling program
Arm ergometer exercise training using the smart trainer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygen Consumption from Baseline to end of Week 8
Time Frame: 8 weeks
Oxygen consumption (VO2) as measured during a graded exercise test using a portable metabolic system
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Severity from Baseline to end of Week 8
Time Frame: 8 weeks
NIH Stroke Scale Test. Scores range from 0 to 42. A higher score indicates greater functional impairment.
8 weeks
Cognitive Function from Baseline to end of Week 8
Time Frame: 8 weeks
Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function
8 weeks
Quality of Life from Baseline to end of Week 8
Time Frame: 8 weeks
Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.
8 weeks
Fatigue Severity from Baseline to end of Week 8
Time Frame: 8 weeks
Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
8 weeks
Grip Strength from Baseline to end of Week 8
Time Frame: 8 weeks
Grip strength as measured using a hand dynamometer
8 weeks
Usability of the Smart Trainer at the end of Week 8
Time Frame: 8 weeks
System Usability Scale. Scores range from 0 to 100. Scores above 68 indicate above average usability. Scores below 68 point to issues with the design that need to be researched and resolved, while scores higher than 68 indicate the need for minor improvements to the design.
8 weeks
Participant feedback regarding the Smart Trainer Program at the end of Week 8
Time Frame: 8 weeks
Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: James H Rimmer, PhD, UAB School of Health Professions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300009387
  • 90REGE000 (Other Grant/Funding Number: NIDILRR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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