- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114629
Biomechanics of Adaptive Rowing in Active and Inactive Manual Wheelchair Users
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19130
- Elizabeth Euiler
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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)
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Collected during Day 2 visit
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Kinematics
Time Frame: Collected during Day 2 visit
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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.
|
Collected during Day 2 visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Muscle Strength
Time Frame: Collected during Day 1 visit
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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].
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Collected during Day 1 visit
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Shoulder Range of Motion
Time Frame: Collected during Day 1 visit
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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.
|
Collected during Day 1 visit
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Subjective quality of life
Time Frame: Collected During Day 1 visit
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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)
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Collected During Day 1 visit
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Community Participation
Time Frame: Collected during Day 1 visit
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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.
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Collected during Day 1 visit
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Descriptive Variables
Time Frame: Collected during Day 1 visit
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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.
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Collected during Day 1 visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Euiler, MS, Drexel University
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-01368
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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