NCT02842008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

Same day

First QC Date

June 6, 2016

Last Update Submit

November 20, 2017

Conditions

Keywords

Exercise TherapyShoulder painShoulder injuriesShoulder functionPreventionWheelchair users

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Neer test

    Baseline and at 10 weeks

  • Hawkins-Kennedy test

    Baseline and at 10 weeks

  • Jobe test

    Baseline and at 10 weeks

  • Patte test

    Baseline and at 10 weeks

  • Shoulder range of motion

    Baseline and at 10 weeks

  • +4 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Wheelchair basketball players participating in home therapeutic exercise program that use the protocol of postural hygiene.

Behavioral: Exercise group

Control group

NO INTERVENTION

Wheelchair basketball players that not participate in home therapeutic exercise program and use a protocol of postural hygiene provided.

Interventions

Exercise groupBEHAVIORAL

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.

Exercise group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Athletic InjuriesShoulder PainShoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Pérez Tejero, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT PhD student

Study Record Dates

First Submitted

June 6, 2016

First Posted

July 22, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations