Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410600
• Other study ID #: IRB-300009387
• Secondary ID: 90REGE000
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: May 18, 2023

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Arm ergometer smart trainer cycling program
Arm ergometer exercise training using the smart trainer.

Locations

Country	Name	City	State
United States	WHARF	Homewood	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen Consumption from Baseline to end of Week 8	Oxygen consumption (VO2) as measured during a graded exercise test using a portable metabolic system	8 weeks
Secondary	Stroke Severity from Baseline to end of Week 8	NIH Stroke Scale Test. Scores range from 0 to 42. A higher score indicates greater functional impairment.	8 weeks
Secondary	Cognitive Function from Baseline to end of Week 8	Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function	8 weeks
Secondary	Quality of Life from Baseline to end of Week 8	Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.	8 weeks
Secondary	Fatigue Severity from Baseline to end of Week 8	Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.	8 weeks
Secondary	Grip Strength from Baseline to end of Week 8	Grip strength as measured using a hand dynamometer	8 weeks
Secondary	Usability of the Smart Trainer at the end of Week 8	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
Secondary	Participant feedback regarding the Smart Trainer Program at the end of Week 8	Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.	8 weeks