What side effects are associated with this type of intervention?

Treatments for sensory disorders, particularly those involving multisensory integration like the CatchU iPhone App, often focus on improving balance and reducing fall risk. Common side effects of these treatments can include mild discomfort or fatigue due to the physical and cognitive demands of the exercises. In some cases, patients may experience temporary dizziness or nausea, especially if the interventions involve significant vestibular stimulation. However, serious adverse events are generally rare.

What prior FDA approvals exist?

FDA approvals for the treatment of sensory disorders have included various devices and medications aimed at improving sensory integration and function. For instance, transcutaneous electrical nerve stimulation (TENS) has been approved for pain management in conditions like fibromyalgia and chronic pain, which indirectly supports sensory integration by alleviating discomfort. Additionally, transcranial magnetic stimulation (TMS) has been approved for treating migraines, which can affect sensory processing. While specific FDA-approved treatments for multisensory integration related to fall risk assessment, like those studied in the CatchU iPhone App trial, are not explicitly mentioned, these approved therapies highlight the ongoing efforts to enhance sensory function and integration through innovative medical devices.

What other types of research exist?

Promising alternatives to the CatchU iPhone App for multisensory integration assessment in sensory disorders patients include: 1) Wearable devices for gait and balance assessment, which provide objective data on patient mobility and stability. 2) Mobile health applications that utilize accelerometers and gyroscopes to monitor physical activity and fall risk in real-time. 3) Remote monitoring systems that integrate behavioral economics to manage and predict fall risk. These tools offer innovative ways to assess and manage sensory disorders, promoting patient independence and improving quality of life.

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CatchU App for Fall Injury Prevention (CatchU Trial)

N/A

Waitlist Available

Led By Mooyeon Oh-Park, MD

Research Sponsored by Jeannette Mahoney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history

Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g., hip or knee replacement) and that prevent participants from completing mobility tests or plans for surgery affecting mobility in the next 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new iPhone app called CatchU, designed to help doctors assess and discuss fall risks with older adults. The app measures how well older adults can respond to visual and touch cues, which helps identify those at higher risk of falling. The goal is to prevent falls, promote independence, and improve quality of life for older adults.

Who is the study for?

The CatchU study is for English-speaking adults aged 65+ living in the New York Metropolitan area who can walk with or without aids like canes. They should be able to visit a clinic and not have severe medical conditions, dementia, major mobility issues due to musculoskeletal pain, progressive neurological diseases, severe sensory impairments, or any psychiatric symptoms that could interfere with the study.

What is being tested?

CatchU Intervention is being tested; it's an iPhone app designed to assess fall risk in older adults. The trial aims to show how well this app predicts falls by using it during clinical visits and follow-up telehealth calls. This pilot study will involve 300 patients over two years.

What are the potential side effects?

Since CatchU is a non-invasive assessment tool used on an iPhone, there are no direct physical side effects associated with its use. However, participants may experience discomfort or anxiety while engaging with technology or discussing their fall risks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a progressive neurological disease like Parkinson's or ALS.

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I was hospitalized for a severe illness or surgery affecting my mobility in the last 6 months.

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My mobility is limited only because of joint issues or pain.

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I have a condition that significantly affects my ability to focus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Falls

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CatchU InterventionExperimental Treatment1 Intervention

Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Intervention arm will be monitored every two months to determine falls history, but will also receive the CatchU intervention which consists of physicians relaying individualized recommendations from the CatchU physician report to the participant, as well as providing the participant with falls intervention referrals and falls counseling.

Group II: ControlActive Control1 Intervention

Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. Meaning, older adults who are enrolled and screened with good integration abilities on the CatchU test (aka: VSI + (good) integrators), (VSI = visual-somatosensory integration) will not be placed in either the intervention or control group since better visual-somatosensory integration performance has been linked to better cognitive and motor outcomes. These participants will be included in examination of additional study aims not related to the intervention. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Control arm will be monitored every two months via telephone surveys to determine falls history, but will not receive the CatchU intervention.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The CatchU iPhone App study emphasizes the importance of multisensory integration in assessing fall risk in older adults. Treatments for sensory disorders often focus on enhancing the brain's ability to integrate information from multiple sensory systems, such as visual, somatosensory, and vestibular inputs. Mechanisms of action include sensory retraining exercises, balance training, and the use of assistive technologies that provide real-time feedback to improve coordination and response times. These treatments are crucial for sensory disorder patients as they help improve cognitive and motor functions, reduce fall risk, and enhance overall quality of life by promoting better sensory processing and integration.

Rehabilitation therapy for patients with disequilibrium and balance disorders.Vestibular Physical Therapy Treatment of Individuals Exposed to Directed Energy.Relationship between touch sensation of the affected hand and performance of valued activities in individuals with chronic stroke.