Trial Outcomes & Findings for Shoulder Instability in Children: Muscle Activity and Movement (NCT NCT04311216)

NCT ID: NCT04311216

Last Updated: 2024-07-22

Results Overview

Number of shoulder instability episodes (subluxation and dislocations)

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: One year
• Results posted on: 2024-07-22

Participant Flow

Participant milestones

Measure	Shoulder Instability Participants Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements	Age Matched Controls (no Instability) Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
Overall Study STARTED	15	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Shoulder Instability Participants n=15 Participants Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements	Age Matched Controls (no Instability) n=15 Participants Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	13.9 years STANDARD_DEVIATION 2.9 • n=15 Participants	13.3 years STANDARD_DEVIATION 3.1 • n=15 Participants	13.6 years STANDARD_DEVIATION 3.0 • n=30 Participants
Sex: Female, Male Female	9 Participants n=15 Participants	7 Participants n=15 Participants	16 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	8 Participants n=15 Participants	14 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: One year

Number of shoulder instability episodes (subluxation and dislocations)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: On admission

Kinematic variables related to the movement tasks - Flexion

Outcome measures

Measure	Shoulder Instability Participants n=15 Participants Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements	Age Matched Controls (no Instability) n=15 Participants Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
Kinematics TS rotation	39 degrees Interval 37.0 to 42.0	40 degrees Interval 40.0 to 44.0
Kinematics TH elevation plane	92 degrees Interval 81.0 to 102.0	94 degrees Interval 86.0 to 102.0
Kinematics TH elevation angle	133 degrees Interval 122.0 to 144.0	130 degrees Interval 125.0 to 134.0
Kinematics TH rotation	100 degrees Interval 87.0 to 113.0	99 degrees Interval 90.0 to 108.0
Kinematics TS protraction	25 degrees Interval 21.0 to 29.0	24 degrees Interval 21.0 to 27.0
Kinematics TS tilt	29 degrees Interval 23.0 to 36.0	33 degrees Interval 27.0 to 38.0
Kinematics GHJ elevation plane	74 degrees Interval 63.0 to 85.0	74 degrees Interval 66.0 to 81.0
Kinematics GHJ elevation angle	101 degrees Interval 89.0 to 112.0	91 degrees Interval 87.0 to 96.0
Kinematics GHJ rotation	89 degrees Interval 79.0 to 99.0	100 degrees Interval 92.0 to 108.0
Kinematics ACJ protraction	32 degrees Interval 25.0 to 39.0	34 degrees Interval 29.0 to 39.0
Kinematics ACJ rotation	16 degrees Interval 13.0 to 20.0	17 degrees Interval 14.0 to 19.0
Kinematics ACJ tilt	31 degrees Interval 28.0 to 34.0	32 degrees Interval 28.0 to 36.0
Kinematics SCJ protraction	25 degrees Interval 20.0 to 29.0	24 degrees Interval 21.0 to 27.0
Kinematics SCJ elevation	11 degrees Interval 10.0 to 12.0	11 degrees Interval 10.0 to 12.0

SECONDARY outcome

Timeframe: On admission

Kinetic variables related to the movement tasks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On admission

Muscle activity patterns related to the movement tasks

Outcome measures

Outcome data not reported

Adverse Events

Shoulder Instability Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Age Matched Controls (no Instability)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Fraser Philp

University of Liverpool

Phone: 01517942000

Email: f.philp@liverpool.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place