WheelchairNCT05114629
Biomechanics of Adaptive Rowing in Active and Inactive Manual Wheelchair Users
An observational study of Wheelchair and Water Sports, run by Drexel University at 1 site in United States.
Trial summary
This research is being performed to characterize the rowing stroke in active and inactive individuals who use a manual wheelchair. The investigators will be looking at muscle activity of four shoulder muscles (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid) and motion of the arms, shoulder… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wheelchair, Water Sports, Upper Extremity
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 17 Aug 2022
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be recruited through personal contact, using flyers, newsletters, email communication, and social media. Participants will be recruited from the community in the Greater Philadelphia area through previously established connections at the Philadelphia Center for Adapted Sports (PCAS) and Magee Rehabilitation Network, as well as through social media platforms (Facebook, Instagram) and the Drexel University College of Nursing and Health Professions webpage.
Who may be able to join
- between 18 and 70 years of age
- use a manual wheelchair for at least 50% of community mobility
- able to transfer independently (with or without the use of adaptive equipment)
- able to achieve humeral elevation of greater than or equal to 90 degrees (bilaterally)
- cleared for exercise participation as indicated by the ACSM Preparticipation Health Screening (Riebe et al., 2015)
- able to read and understand English
Who cannot join
- have an active pressure sore or skin breakdown
- have a presence of shoulder pain as indicated by a score of greater than 12 on the Wheelchair Users Shoulder Pain Index (Mulroy et al., 2015)
- have impaired upper extremity function as indicated by a score of greater than 40 on the QuickDASH (Angst et al., 2011; Kennedy et al., 2011)
Trial locations and contacts
1 site in 1 country.
About this study
This research is being performed to characterize the rowing stroke in active and inactive individuals who use a manual wheelchair. The investigators will be looking at muscle activity of four shoulder muscles (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid) and motion of the arms, shoulder blade, and trunk during rowing. This will be done for three rowing conditions (1: adapted rowing ergometer, 2: rowing ergometer from a chair, 3: standard seated row exercise using an elastic band [TheraBand]). The investigators are also looking at shoulder strength, range of motion, quality of life, and community participation.
Read the detailed description
Individuals who use a manual wheelchair (MWC) are at a high risk of developing long-term shoulder pain and impairment caused by increased demand and load on the shoulder during normal daily activities. Two main contributors to shoulder pain are overuse and shoulder muscle imbalance. Rehabilitation programs targeting shoulder pain suggest stretching anterior shoulder muscles and strengthening posterior shoulder muscles to promote balance and stability across the shoulder. Rowing-type exercises have been shown to be beneficial in accomplishing this. In addition to reducing shoulder pain, it is crucial to identify methods and modes of exercise which are more widely accessible. Participation in physical activity provides physical, psychological, and social benefits. However, several barriers to physical activity have been reported in this population. Less than half of individuals with physical disabilities meet the American College of Sports Medicine's physical activity guidelines.
The primary aim of this study is to determine the biomechanics of the rowing stroke in active and inactive individuals who use a MWC for mobility. Muscle activity (electromyography) of four shoulder muscles (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid) and 3D motion analysis of the arms, shoulder blade, and trunk will be analyzed across three rowing conditions (adapted rowing ergometer, rowing ergometer from chair, standard row exercise). The investigators hypothesize rowing on the adapted rowing ergometer will lead to greater muscle activity than the standard rowing exercise and there will be no difference in arm, shoulder blade, and trunk movement between rowing conditions. The secondary aim of this study is to assess shoulder range of motion, pectoralis minor muscle extensibility, quality of life, and community participation. The investigators hypothesize active individuals will have a greater range of motion and pectoralis minor muscle extensibility and report lower quality of life and community participation than inactive individuals. This study seeks to lay the groundwork of evidence to suggest participation in rowing as a viable option to reduce the frequency and intensity of shoulder pain and provide a more accessible form of physical activity. Additionally, the investigators hope to contribute further insight into clinical measures (shoulder strength, range of motion, pectoralis minor muscle extensibility), subjective quality of life, and community participation in this population.
- Conditions
- Wheelchair, Water Sports, Upper Extremity, Biomechanics, Electromyography, Kinematics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active | Individuals in the active group will meet or exceed the American College of Sports Medicine's Guidelines for Physical Activity in Adults with Chronic Health Conditions and Disabilities. ACMS recommends individuals participate in at least 150 to 300 minutes of moderate-intensity aerobic exercise, 75 to 150 minutes of vigorous-intensity activity.(health.gov/ PAGuidelines) | |
| Inactive | Individuals in the inactive group are those who do not meet the American College of Sports Medicine's Guidelines for Physical Activity in Adults with Chronic Health Conditions and Disabilities. ACMS recommends individuals participate in at least 150 to 300 minutes of moderate-intensity aerobic exercise, 75 to 150 minutes of vigorous-intensity activity.(health.gov/ PAGuidelines) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
Surface EMG will be used to determine levels of muscle activation through analyzing area under the curve, peak, and mean amplitude. Data will be collected on four muscles bilaterally (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid).Peak dynamic method will be used for normalization for comparison between exercise conditions.(Ryan et al., 1992; Fleming \& Donne, 2014; Hug \& Dorel, 2009)
Measured: Collected during Day 2 visit
Kinematics
Three-dimensional kinematic data of the trunk, arms, and scapula will be collected using the Motion Monitor electromagnetic transmitter system (Innovative Sports Training, Inc., Chicago, IL). The International Society of Biomechanics recommendations for shoulder kinematics, will be used to define sensor placement and global and local coordinate system definitions.(Wu et al., 2005) Using this data, we will analyze the coordination and symmetry of the upper extremity during the rowing stroke to supplement the EMG data.
Measured: Collected during Day 2 visit
Secondary outcomes (5)
Shoulder Muscle Strength
Shoulder girdle strength will be measured bilaterally using a handheld dynamometer (HHD) (Lafayette Manual Muscle Tester, Lafayette, IN). Flexion, extension, abduction, adduction, internal, and external rotation strength will be measured. Standard manual muscle testing positions, as previously described by Kendall et al., 2005 will be used with a modification to allow participants to remain in their wheelchairs during testing. Peak force, measured in kilograms (kg), will be normalized to body weight (BW) for comparison across participants [%BW=(forcekg/BWkg)*100].
Measured: Collected during Day 1 visit
Shoulder Range of Motion
Active shoulder ROM will be measured bilaterally for elevation, extension, external rotation (humerus in 90° elevation), and internal rotation. ROM will be measured using goniometer and analyzed using the maximum value recorded over two trials.
Measured: Collected during Day 1 visit
Subjective quality of life
The SQoL is a self-report questionnaire measuring the individual's overall perception of their quality of life. The SQoL consists of one question asking individuals to rate their overall quality of life taking everything into account. The question is measured using a Likert-type scale where 1 = life is very distressing, it's hard to imagine how it could get much worse; to 7 = life is great, it's hard to imagine how it could get much better.(Dijkers, 2005)
Measured: Collected During Day 1 visit
Community Participation
The Community Participation Indicators' Enfranchisement Scale (CPI) will be used to measure community participation. The CPI is a 48-question self-report questionnaire measuring two domains of community participation, importance of participation and control over participation.(Heinemann et al., 2013) Questions are answered by selecting one of five options: "all the time, frequently, sometimes, seldom, and almost never". The score is broken down by domain and scores range from 0 to 100 for each domain. A higher score is indicative of greater participation.
Measured: Collected during Day 1 visit
Descriptive Variables
Descriptive variables will be collected including age, gender, race, ethnicity, education, socioeconomic status, self-reported general medical history and history of health condition/injury; wheelchair specifics.
Measured: Collected during Day 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start14 Sep 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheelchairStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Elizabeth Euiler, MS, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114629
- Sponsor's protocol ID
- 20-01368
- Status last verified
- Jan 2023
- First submitted
- 29 Oct 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics of Adaptive Rowing in Active and Inactive Manual Wheelchair Users
- ClinicalTrials.gov ID
- NCT05114629
- Acronym / sponsor ID
- 20-01368
- Conditions
- Wheelchair, Water Sports, Upper Extremity, Biomechanics, Electromyography, Kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 10 Nov 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.
This research is being performed to characterize the rowing stroke in active and inactive individuals who use a manual wheelchair. The investigators will be looking at muscle activity of four shoulder muscles (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid) and motion of the arms, shoulder blade, and trunk during rowing. This will be done for three rowing conditions (1: adapted rowing ergometer, 2: rowing ergometer from a chair, 3: standard seated row exercise using an elastic band [TheraBand]). The investigators are also looking at shoulder strength, range of motion, quality of life, and community participation.
Detailed description
Individuals who use a manual wheelchair (MWC) are at a high risk of developing long-term shoulder pain and impairment caused by increased demand and load on the shoulder during normal daily activities. Two main contributors to shoulder pain are overuse and shoulder muscle imbalance. Rehabilitation programs targeting shoulder pain suggest stretching anterior shoulder muscles and strengthening posterior shoulder muscles to promote balance and stability across the shoulder. Rowing-type exercises have been shown to be beneficial in accomplishing this. In addition to reducing shoulder pain, it is crucial to identify methods and modes of exercise which are more widely accessible. Participation in physical activity provides physical, psychological, and social benefits. However, several barriers to physical activity have been reported in this population. Less than half of individuals with physical disabilities meet the American College of Sports Medicine's physical activity guidelines.
The primary aim of this study is to determine the biomechanics of the rowing stroke in active and inactive individuals who use a MWC for mobility. Muscle activity (electromyography) of four shoulder muscles (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid) and 3D motion analysis of the arms, shoulder blade, and trunk will be analyzed across three rowing conditions (adapted rowing ergometer, rowing ergometer from chair, standard row exercise). The investigators hypothesize rowing on the adapted rowing ergometer will lead to greater muscle activity than the standard rowing exercise and there will be no difference in arm, shoulder blade, and trunk movement between rowing conditions. The secondary aim of this study is to assess shoulder range of motion, pectoralis minor muscle extensibility, quality of life, and community participation. The investigators hypothesize active individuals will have a greater range of motion and pectoralis minor muscle extensibility and report lower quality of life and community participation than inactive individuals. This study seeks to lay the groundwork of evidence to suggest participation in rowing as a viable option to reduce the frequency and intensity of shoulder pain and provide a more accessible form of physical activity. Additionally, the investigators hope to contribute further insight into clinical measures (shoulder strength, range of motion, pectoralis minor muscle extensibility), subjective quality of life, and community participation in this population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | –Individuals in the active group will meet or exceed the American College of Sports Medicine's Guidelines for Physical Activity in Adults with Chronic Health Conditions and Disabilities. ACMS recommends individuals participate in at least 150 to 300 minutes of moderate-intensity aerobic exercise, 75 to 150 minutes of vigorous-intensity activity.(health.gov/ PAGuidelines) |
| Inactive | – | –Individuals in the inactive group are those who do not meet the American College of Sports Medicine's Guidelines for Physical Activity in Adults with Chronic Health Conditions and Disabilities. ACMS recommends individuals participate in at least 150 to 300 minutes of moderate-intensity aerobic exercise, 75 to 150 minutes of vigorous-intensity activity.(health.gov/ PAGuidelines) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited through personal contact, using flyers, newsletters, email communication, and social media. Participants will be recruited from the community in the Greater Philadelphia area through previously established connections at the Philadelphia Center for Adapted Sports (PCAS) and Magee Rehabilitation Network, as well as through social media platforms (Facebook, Instagram) and the Drexel University College of Nursing and Health Professions webpage.
Key inclusion criteria (6 listed)
- between 18 and 70 years of age
- use a manual wheelchair for at least 50% of community mobility
- able to transfer independently (with or without the use of adaptive equipment)
- able to achieve humeral elevation of greater than or equal to 90 degrees (bilaterally)
- cleared for exercise participation as indicated by the ACSM Preparticipation Health Screening (Riebe et al., 2015)
Key exclusion criteria (3 listed)
- have an active pressure sore or skin breakdown
- have a presence of shoulder pain as indicated by a score of greater than 12 on the Wheelchair Users Shoulder Pain Index (Mulroy et al., 2015)
- have impaired upper extremity function as indicated by a score of greater than 40 on the QuickDASH (Angst et al., 2011; Kennedy et al., 2011)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electromyography
Time frame: Collected during Day 2 visit
Surface EMG will be used to determine levels of muscle activation through analyzing area under the curve, peak, and mean amplitude. Data will be collected on four muscles bilaterally (upper trapezius, lower trapezius, serratus anterior, and posterior deltoid).Peak dynamic method will be used for normalization for comparison between exercise conditions.(Ryan et al., 1992; Fleming \& Donne, 2014; Hug \& Dorel, 2009)
Kinematics
Time frame: Collected during Day 2 visit
Three-dimensional kinematic data of the trunk, arms, and scapula will be collected using the Motion Monitor electromagnetic transmitter system (Innovative Sports Training, Inc., Chicago, IL). The International Society of Biomechanics recommendations for shoulder kinematics, will be used to define sensor placement and global and local coordinate system definitions.(Wu et al., 2005) Using this data, we will analyze the coordination and symmetry of the upper extremity during the rowing stroke to supplement the EMG data.
5 secondary outcomes
Shoulder Muscle Strength
Time frame: Collected during Day 1 visit
Shoulder Range of Motion
Time frame: Collected during Day 1 visit
Subjective quality of life
Time frame: Collected During Day 1 visit
Community Participation
Time frame: Collected during Day 1 visit
Descriptive Variables
Time frame: Collected during Day 1 visit
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 30 Jan 2023.
- 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.
Elizabeth Euiler, MS principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheelchair and Water Sports, run by Drexel University 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 6 inclusion and 3 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 30 Jan 2023. 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?
Electromyography (time frame: Collected during Day 2 visit). 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?
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 30 Jan 2023.