- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Alabama
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Homewood, Alabama, Forente stater, 35209
- UAB/Lakeshore Research Colaborative Building
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Self-Selected Speed (meters per second)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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Average linear propulsion speed during each completed propulsion cycle (i.e.
contact+recovery) 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 Rolling Resistance (Newtons)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of completed propulsion cycles used to generate the outcomes of interest
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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
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Average resultant force (Newtons)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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
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Average rate of rise of resultant force (Newtons per second squared)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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)
Tidsramme: 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)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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.
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Seconds 20 to 40 of each 1 minute propulsion bout
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Average propulsive torque (Newton meter)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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)
Tidsramme: 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
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Average external power output (Watts)
Tidsramme: Seconds 20 to 40 of each 1 minute propulsion bout
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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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB-300007513
Plan for individuelle deltakerdata (IPD)
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