Cueing Device for Healthy Volunteers

Overseen By Kevin Strehler, DPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Alabama

Disqualifiers: Under 11, Not USA Swimming, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an external cueing device (ECD) can help young swimmers improve shoulder muscle strength and stability. The ECD restricts arm movement and provides a target for swimmers to focus on during exercises. Participants will incorporate this device into their regular training routine to assess its impact. Swimmers who are healthy and part of the CMSA (a swimming organization) may be suitable candidates for this trial. As an unphased trial, it offers swimmers the chance to enhance their training with innovative techniques.

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.

What prior data suggests that this external cueing device is safe for young swimmers?

Research has shown that external cueing devices (ECDs) have been tested in various situations. For example, studies have found that ECDs can help individuals maintain better balance during activities involving audio and visual signals to prepare for movement. These studies did not report any serious safety issues, suggesting that ECDs are generally safe to use.

People with Parkinson's disease have also used ECDs to increase physical activity, such as improving walking. Again, these devices did not cause significant negative effects, indicating their safety for users.

While specific information about the safety of ECDs for young swimmers is limited, their use in other areas suggests they are likely safe. Since this trial is not classified under a specific phase, it likely focuses on testing the device's effectiveness rather than initial safety, further supporting its safety in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to shoulder stabilization exercises using an external cueing device. Unlike traditional exercises that rely solely on standard coaching, this device offers a movement pattern constraint and an external target zone, which could enhance precision and effectiveness. By providing these additional visual and physical cues, the device may improve the way exercises are performed, potentially leading to better outcomes in shoulder stabilization.

What evidence suggests that this external cueing device is effective for improving shoulder function in young swimmers?

Research shows that using an external cueing device (ECD) can help people become more active and perform tasks better. Studies have found that cueing can improve activities like walking by providing patterns or targets for focus. This method has succeeded in various conditions, including neurological ones, by enhancing task performance. In this trial, one group will perform shoulder stabilization exercises with the ECD, which is expected to increase shoulder strength and stability by guiding movements during exercises. While specific data on young swimmers is limited, related research on shoulder exercises suggests that this type of training can improve shoulder function and prevent injuries. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

Swimmers currently not participating in a dryland program offered through CMSA

Swimmers that are not registered as athletes through United States Swimming

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Shoulder Stabilization Exercise with External Cueing Device Experimental Treatment 2 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 Exercise Active Control 1 Intervention

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. Standard group coaching assistance will be provided.

Who Is Running the Clinical Trial?

University of South Alabama

Lead Sponsor

Trials

44

Recruited

15,800+

Published Research Related to This Trial

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]

Citations

1. clinconnect.io clinconnect.io/trials/NCT06923930

Impact of a Cueing Device on Upper Extremity Muscle 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3820191/

Clinical Usefulness of Shoulder Stability Exercises for ... The results of this study show that shoulder stability exercise can improve the shoulder function of middle-aged women, and prevent damage to the shoulder ...

3. researchgate.net researchgate.net/publication/41548401_Does_Cueing_Training_Improve_Physical_Activity_in_Patients_With_Parkinson's_Disease

Does Cueing Training Improve Physical Activity in Patients ... Significant improvements were found for dynamic activity (beta= 4.46; P < .01), static activity (beta=-3.34; P < .01), walking (beta= 4.23; P < ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29523022/

Effectiveness of external cues to facilitate task performance ... Providing cues is a core component of rehabilitation and may improve successful task performance and activities in people with neurological conditions.

5. e-jer.org e-jer.org/journal/view.php?number=2013601061

Effectiveness of proprioceptive neuromuscular facilitation ... This study explores the effect of proprioceptive neuromuscular facilitation (PNF) exercises combined with a virtual reality (VR) motion capture system and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9132693/

The Efficacy of a Newly Developed Cueing Device for Gait ... External cues are effective in improving gait in people with Parkinson's disease (PD). However, the most effective cueing method has yet to be ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23139427/

Effect of externally cued training on dynamic stability control ... Task-specific training with preparatory audiovisual cues resulted in improved overall dynamic stability against both forward and backward balance loss.

8. mdpi.com mdpi.com/1424-8220/19/6/1277

A Technological Review of Wearable Cueing Devices ... This paper aims to provide a technological review of the literature related to wearable cueing systems and it focuses on current auditory, visual and ...