Healthy ParticipantsNCT04987177
Effect of Manual Wheelchair Propulsion Workload on Speed, Energy Expenditure, and Propulsion Mechanics
A study testing Workload of Manual Wheelchair Propulsion in people with Healthy Participants, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Workload of Manual Wheelchair Propulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2021to 13 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no additional exclusion criteria if otherwise eligible to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB/Lakeshore Research Colaborative Building
Homewood, Alabama, 35209
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Participants
- Being tested
- Workload of Manual Wheelchair Propulsion
- Keywords
- workload, wheelchair, biomechanics, energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workload of Manual Wheelchair PropulsionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Workload conditions to be tested | Experimental | 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. Receives: Other: Workload of Manual Wheelchair Propulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Selected Speed (meters per second)
Average linear propulsion speed during each completed propulsion cycle (i.e. contact+recovery) averaged across all completed propulsion cycles in the specified time frame.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average Rolling Resistance (Newtons)
Average rolling resistance during each completed propulsion cycle (i.e. contact+recovery) averaged across all completed propulsion cycles in the specified time frame.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Secondary outcomes (10)
Number of completed propulsion cycles used to generate the outcomes of interest
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average resultant force (Newtons)
Average resultant force during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average rate of rise of resultant force (Newtons per second squared)
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average push frequency (pushes per minute)
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average push length (Degrees)
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average propulsive torque (Newton meter)
Average propulsive torque during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the specified time frame.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average push power output (Watts)
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average total work per push (Joules)
Total work during the contact phase of each completed propulsion cycle averaged across all completed propulsion cycles in the time frame of interest.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Average external power output (Watts)
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.
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Frequency of each unique propulsion pattern
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].
Measured: Seconds 20 to 40 of each 1 minute propulsion bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start7 Aug 2021
- Primary completion13 Nov 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Cowan, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987177
- Sponsor's protocol ID
- IRB-300007513
- Status last verified
- Feb 2022
- First submitted
- 16 Jul 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soleymani H, Cowan R. Relationship between rolling resistance, preferred speed, and manual wheelchair propulsion mechanics in non-disabled adults. Disabil Rehabil Assist Technol. 2024 Jul;19(5):1980-1991. doi: 10.1080/17483107.2023.2239297. Epub 2023 Jul 26.
PubMed 37493253
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Among Manual Wheelchair Workload, Speed, Energy Expenditure, and Propulsion Mechanics
- ClinicalTrials.gov ID
- NCT04987177
- Acronym / sponsor ID
- IRB-300007513
- Conditions
- Healthy Participants
- Keywords
- workload, wheelchair, biomechanics, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workload conditions to be tested | Experimental | Other: Workload of Manual Wheelchair PropulsionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- no additional exclusion criteria if otherwise eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workload of Manual Wheelchair PropulsionParticipants 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. | Other | Workload conditions to be tested |
Primary outcome
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.
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.
10 secondary outcomes
Number of completed propulsion cycles used to generate the outcomes of interest
Time frame: 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 rate of rise of resultant force (Newtons per second squared)
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Average push frequency (pushes per minute)
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Average push length (Degrees)
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Average propulsive torque (Newton meter)
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Average push power output (Watts)
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Average total work per push (Joules)
Time frame: 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
Frequency of each unique propulsion pattern
Time frame: Seconds 20 to 40 of each 1 minute propulsion bout
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 37493253Soleymani H, Cowan R. Relationship between rolling resistance, preferred speed, and manual wheelchair propulsion mechanics in non-disabled adults. Disabil Rehabil Assist Technol. 2024 Jul;19(5):1980-1991. doi: 10.1080/17483107.2023.2239297. Epub 2023 Jul 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workload of Manual Wheelchair Propulsion in people with Healthy Participants, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Selected Speed (meters per second) (time frame: Seconds 20 to 40 of each 1 minute propulsion bout). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.