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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02842008
Other study ID # UPMadrid
Secondary ID
Status Completed
Phase N/A
First received June 6, 2016
Last updated November 20, 2017
Start date July 2016
Est. completion date August 2017

Study information

Verified date November 2017
Source Universidad Politecnica de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The hypothesis of the study was that the exercise program was effective to prevent shoulder injuries in this population.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years to 45 Years
Eligibility 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 Design


Intervention

Behavioral:
Exercise group
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.

Locations

Country Name City State
Spain Universidad Politécnica de Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline shoulder pain at 10 weeks 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). Baseline and at 10 weeks
Secondary Neer test Neer's Test assesses for possible rotator cuff impingement. Pain is a positive test. Baseline and at 10 weeks
Secondary Hawkins-Kennedy test Hawkins-Kennedy`s test indicative a possible impingement between the greater tuberosity of the humerus against the coraco- humeral ligament. Baseline and at 10 weeks
Secondary Jobe test Jobe`s test assesses for possible supraspinatus weakness and/or impingement. Baseline and at 10 weeks
Secondary Patte test Patte`s test measure for possible infraspinatus and teres minor weakness and/or impingement. Baseline and at 10 weeks
Secondary Shoulder range of motion 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. Baseline and at 10 weeks
Secondary Players´ adherence to the exercise program Players will complete a questionnaire rating their adherence to the exercise program. At 4 and 8 weeks
Secondary Players´ self-efficacy to the exercise program Players will complete a questionnaire about the self-efficacy according to the exercise program. Baseline
Secondary Players adherence to the protocol of postural hygiene. Players will complete a follow-up questionnaire rating their adherence to the protocol of postural hygiene. At 4 and 8 weeks
Secondary Activities performed outside of the training and exercise program. Players will be complete a follow-up questionnaire about the activities performed outside of the training and exercise program. At 4 and 8 weeks
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