- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842008
Effects of a Therapeutic Exercise Program for Injuries Prevention in Wheelchair Basketball (WB) Players
Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball players. About the 85% of this population had shoulder pain in some moment of their life. Some studies suggest that exercise is an important tool as an element to treat and prevent shoulder injuries. For that reason, an intervention program would be a useful tool for prevent shoulder injuries in this population.
The purpose of this study is determine the effects of therapeutic exercise program wheelchair basketball players, in order to prevent shoulder injuries.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28040
- Universidad Politecnica de Madrid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Population 36 wheelchair basketball players belonging to the male and female preselection Spanish wheelchair basketball national team were recruiting during a campus. The inclusion and exclusion criteria were chosen to include a specific population.
Inclusion Criteria:
- Players belonging to the male and female preselection Spanish wheelchair basketball national team.
- Have the federal license at the Spanish Sport Federation for People with Physical Disabilities available at the time of the study (2015-2016 season).
- For players using wheelchair for daily activities, to use the manual wheelchair at least for 3 hours a day and 6 hours of wheelchair basketball training per week.
- For players not using wheelchair for daily activities, to use the manual wheelchair at least for 6 hours of wheelchair basketball training per week.
- Use wheelchair at least one year before the study and at least one year of experience in the sport competition.
- Acceptance of informed consent.
Exclusion Criteria:
- History of acute injuries in the post-surgical process or dislocation along the year before the study. These conditions may affect the effective of the exercise intervention.
- Differential diagnosis as acute injuries at cervical region and recent traumatic injury in shoulder one year before the study. The exercise program may not be appropriate for these conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
Wheelchair basketball players participating in home therapeutic exercise program that use the protocol of postural hygiene.
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This group will receive a home exercise program of shoulder based on mobility, strength and strengthening exercises, lasting 10 weeks, 3 times per weeks.
The target dose use for mobility consisted in 8 repetitions for each 4 movements, for strengthening using resistive bands, 3 sets (including 5 exercises) of 10 repetitions with a 45 second rest between sets and 5 repetitions for each 5 strength with a 30 second rest and general protocol of postural hygiene.
The instructional of the program is 30 minutes each day during the time of the study (10 weeks) with a screening about the exercise program and the daily activities performed every 4 weeks.
Physiotherapist provided support to subjects through email along 10 weeks.
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No Intervention: Control group
Wheelchair basketball players that not participate in home therapeutic exercise program and use a protocol of postural hygiene provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline shoulder pain at 10 weeks
Time Frame: Baseline and at 10 weeks
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The presence of shoulder pain will be measured at the beginning and at 10 weeks with "Shoulder Pain Index for Wheelchair Basketball (SPI-WB)" (submitting).
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Baseline and at 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neer test
Time Frame: Baseline and at 10 weeks
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Neer's Test assesses for possible rotator cuff impingement.
Pain is a positive test.
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Baseline and at 10 weeks
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Hawkins-Kennedy test
Time Frame: Baseline and at 10 weeks
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Hawkins-Kennedy's test indicative a possible impingement between the greater tuberosity of the humerus against the coraco- humeral ligament.
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Baseline and at 10 weeks
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Jobe test
Time Frame: Baseline and at 10 weeks
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Jobe's test assesses for possible supraspinatus weakness and/or impingement.
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Baseline and at 10 weeks
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Patte test
Time Frame: Baseline and at 10 weeks
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Patte's test measure for possible infraspinatus and teres minor weakness and/or impingement.
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Baseline and at 10 weeks
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Shoulder range of motion
Time Frame: Baseline and at 10 weeks
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The range of motion will be evaluated in flexion, extension, internal rotation, external rotation and abduction with a goniometric at the beginning and at 10 weeks.
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Baseline and at 10 weeks
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Players´ adherence to the exercise program
Time Frame: At 4 and 8 weeks
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Players will complete a questionnaire rating their adherence to the exercise program.
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At 4 and 8 weeks
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Players´ self-efficacy to the exercise program
Time Frame: Baseline
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Players will complete a questionnaire about the self-efficacy according to the exercise program.
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Baseline
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Players adherence to the protocol of postural hygiene.
Time Frame: At 4 and 8 weeks
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Players will complete a follow-up questionnaire rating their adherence to the protocol of postural hygiene.
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At 4 and 8 weeks
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Activities performed outside of the training and exercise program.
Time Frame: At 4 and 8 weeks
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Players will be complete a follow-up questionnaire about the activities performed outside of the training and exercise program.
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At 4 and 8 weeks
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Collaborators and Investigators
Investigators
- Study Director: Javier Pérez Tejero, PhD, Universidad Politécnica de Madrid.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPMadrid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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