- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987177
Effect of Manual Wheelchair Propulsion Workload on Speed, Energy Expenditure, and Propulsion Mechanics
Relationship Among Manual Wheelchair Workload, Speed, Energy Expenditure, and Propulsion Mechanics
The first purpose of this study is to characterize the relationship among propulsion workload, self-selected propulsion speed, and propulsion kinetics/kinematics.
The second purpose is to assess the between days repeatability/reliability of the above outcomes.
There are no hypothesis
This is a repeated measures clinical trial. All participants will complete the following: 1) Acclimation to propelling a manual wheelchair on a wheelchair ergometer; 2) Graded exercise test on the wheelchair ergometer to 80% of age adjusted estimated maximal heart rate; and 3) N=20 one minute propulsion bouts on the wheelchair ergometer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will complete two visits in a 14 day period. Visit 1 will require 3-4 hours. Visit 2 will require 2-3 hours.
During visit 1 participant will complete: 1) Acclimation to propelling a manual wheelchair on a wheelchair ergometer; 2) Graded exercise test on the wheelchair ergometer to 80% of age adjusted estimated maximal heart rate; and 3) N=20 one minute propulsion bouts on the wheelchair ergometer.
During visit 2 participants will repeat the N=20 one minute propulsion bouts on the wheelchair ergometer.
Wheelchair ergometer propulsion acclimation: Participants will complete a minimum of 2 minutes of wheelchair propulsion to acclimate. Additional propulsion time will be completed as needed. Propulsion workload will be varied during the acclimation. Acclimation propulsion may be repeated as needed during study participation.
Submaximal wheelchair ergometer test protocol: Participants will rest quietly in the wheelchair for several minutes. After resting, participants will begin propelling at a comfortable speed at a low initial workload. Workload will be increased every minute. Propulsion speed will remain constant across all workloads. Test will end when participants reach 80% of age adjusted estimated maximum heart rate.
Wheelchair propulsion workload assessment: Participants will complete 20 one-minute propulsion bouts at a self-selected speed. Each one minute propulsion bout will be followed by a 2 minute rest period. Each propulsion bout will be at a different workload. After the first 10 propulsion bouts, participants will be provided with an extended rest period (5 to 30 minutes). For each participant, the maximum workload to be tested is based on their estimated maximum workload. Estimate maximum workload is based on the Heart Rate-Workload relationship documented during the submaximal test.
The workloads of the N=20 propulsion bouts will be divided into two groups of N=10 (Group A and Group B). The total workload of each group will be equal. Within each group, workload sequence is fixed and arranged in a non-ascending or descending order. Completion order of the groups will be counterbalanced within sex. Within participants, completion order will be counterbalanced across days
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Homewood, Alabama, United States, 35209
- UAB/Lakeshore Research Colaborative Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18 years or older
- cleared to participate in physical activity as determined by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- self-reported ability to propel a manual wheelchair
- not currently disabled
Exclusion Criteria:
- no additional exclusion criteria if otherwise eligible to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Workload conditions to be tested
The intervention is the external workload a participant propels against.
Participants will propel against N=20 different external workloads.External workload will be controlled by the wheelchair ergometer.
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Participants will complete 20 one-minute manual wheelchair propulsion bouts.
Each one minute propulsion bout will be followed by a 2 minute rest period.
Each propulsion bout will be at a different workload.
After every 10 propulsion bouts, participants will be provided with an extended rest period (5 to 30 minutes).
For each participant, the maximum workload to be tested is based on their estimated maximum workload.
Estimate maximum workload is based on the HR-Workload relationship documented during a prior sub maximal test to 80% of age adjusted maximum heart rate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Selected Speed (meters per second)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average linear propulsion speed during each completed propulsion cycle (i.e.
contact+recovery) averaged across all completed propulsion cycles in the specified time frame.
|
Seconds 20 to 40 of each 1 minute propulsion bout
|
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Average Rolling Resistance (Newtons)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average rolling resistance during each completed propulsion cycle (i.e.
contact+recovery) averaged across all completed propulsion cycles in the specified time frame.
|
Seconds 20 to 40 of each 1 minute propulsion bout
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of completed propulsion cycles used to generate the outcomes of interest
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
The number of complete propulsion cycles occurring in the specified time frame.
A complete propulsion cycle is defined as beginning with the onset of contact with the pushrim and ending with the onset of contact of the next propulsion cycle.
A propulsion cycle includes contact and recovery.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
|
Average resultant force (Newtons)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average resultant force during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
|
Average rate of rise of resultant force (Newtons per second squared)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average rate of rise of resultant force during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
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Average push frequency (pushes per minute)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
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For the specified time frame, the total number of completed propulsion cycles divided by the time to complete all the propulsion cycles in seconds multiplied by 60 seconds.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
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Average push length (Degrees)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
The distance over which a propulsive torque is applied to the pushrim during the contact phase of each complete propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
|
Seconds 20 to 40 of each 1 minute propulsion bout
|
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Average propulsive torque (Newton meter)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average propulsive torque during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
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Average push power output (Watts)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average power during the contact phase of each each completed propulsion cycle averaged across all completed propulsion cycles in the time frame of interest.
Push power output represents the energy the person applies to the pushrim during the contact phase.
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Seconds 20 to 40 of each 1 minute propulsion bout
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Average total work per push (Joules)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
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Total work during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the time frame of interest.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
|
Average external power output (Watts)
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
|
Average external power output during the entire propulsion cycle (i.e.
contact and recovery) averaged across all completed propulsion cycles in the specified time frame.
External power output represents the energy expended by the user-wheelchair system.
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Seconds 20 to 40 of each 1 minute propulsion bout
|
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Frequency of each unique propulsion pattern
Time Frame: Seconds 20 to 40 of each 1 minute propulsion bout
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For each complete propulsion cycle during the specified time frame, the recovery pattern will be classified into one of 5 categories: semi-circular, arcing, single loop, double loop, or indeterminate.
The number of cycles and overall percentage in each category will be reported.
Overall percentage is defined as [number of cycles in a category/total number of cycles * 100].
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Seconds 20 to 40 of each 1 minute propulsion bout
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-300007513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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