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Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

30 Participants Needed

Cueing Device for Healthy Volunteers

Overseen ByKevin Strehler, DPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Alabama

Disqualifiers: Under 11, Not USA Swimming, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves healthy adolescent swimmers, it is likely that no medication changes are required.

Is the Cueing Device generally safe for humans?

The safety of treatments like the Cueing Device is often evaluated in clinical trials, but safety reporting can be inconsistent. It's important to know that adverse events (unwanted side effects) are sometimes underreported, and systematic tracking is needed to ensure safety. While specific data on the Cueing Device isn't provided, general safety practices in trials suggest that careful monitoring and reporting are crucial for understanding safety in humans.¹ ² ³ ⁴ ⁵

How does the External Cueing Device treatment differ from other treatments for this condition?

The External Cueing Device is unique because it uses external signals to assist individuals, which is different from traditional treatments that might not involve such interactive or assistive technology. This approach is similar to assistive devices used for people with disabilities, focusing on enhancing the user's ability to perform tasks through ergonomic and human-centered design.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The goal of this study is to find out if a tool called an external cueing device (ECD) can help young swimmers improve their shoulder function. An ECD is a tool that limits arm movement and gives the swimmer a target to focus on while doing exercises. The main questions this study will answer are:* Does using an ECD during certain exercises improve muscle strength?* Does using an ECD while exercising help with shoulder stability?Participants will:* Test their shoulder muscle strength and stability at the beginning of the study.* Complete 8 exercises as part of their regular dry-land training program for 6 weeks.* Repeat the same tests after 3 weeks and again at the end of the study.

Eligibility Criteria

This trial is for healthy adolescent swimmers who are part of CMSA. They must be at least 11 years old, registered with United States Swimming, and enrolled in specific age groups or senior levels. Swimmers with injuries or those not in a CMSA dryland program cannot participate.

Inclusion Criteria

I am a healthy adolescent swimmer and a member of CMSA.

Exclusion Criteria

Swimmers currently not participating in a dryland program offered through CMSA

Swimmers not attending practice due to an injury (i.e., shoulder, back, etc.)

Swimmers that are not registered as athletes through United States Swimming

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Testing

Participants test their shoulder muscle strength and stability

1 week

1 visit (in-person)

Treatment

Participants complete 8 exercises as part of their regular dry-land training program using an external cueing device for 6 weeks

6 weeks

3 visits (in-person) for testing at baseline, 3 weeks, and 6 weeks

Follow-up

Participants are monitored for changes in muscle strength and shoulder stability after the treatment

4 weeks

Treatment Details

Interventions

External Cueing Device

Trial Overview The study tests if an external cueing device (ECD) can boost shoulder muscle strength and stability when used during exercises. Participants will incorporate the ECD into their regular training over six weeks and have their muscle function tested periodically.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Shoulder Stabilization Exercise with External Cueing DeviceExperimental Treatment2 Interventions

Protocol contains 8 exercises ("I", "Y", "T", "i", "w", alternating arm "I"/"i", "n", and supine serratus punch) completed for 8 repetitions each for 3 weeks, and in weeks 4-6 completed at 2 sets of 8 repetitions each. External cueing device provides movement pattern constraint and an external target zone for the individual for each exercise. Standard group coaching assistance will be provided.

Group II: Shoulder Stabilization ExerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Alabama

Lead Sponsor

Trials

Recruited

15,800+

Findings from Research

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system.Shenvi, NV., Gebhart, SS.[2009]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection.Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials.Ioannidis, JP., Lau, J.[2018]