What is the mechanism of action of this treatment?

The most common treatments for physical disabilities, particularly those involving integrated health services like comprehensive rehabilitation and support, work through several mechanisms. Physical therapy and exercise programs focus on muscle strengthening and balance training, which improve mobility and prevent falls. Pain management techniques reduce discomfort, allowing for more active participation in daily activities. Home modifications create safer environments, reducing the risk of injury. These interventions are essential for patients with physical disabilities as they collectively enhance independence, improve quality of life, and minimize the risk of further disability.

What side effects are associated with this type of intervention?

Common treatments for physical disabilities, such as physical therapy, occupational therapy, muscle strengthening, balance training, and pain management, generally have minimal side effects. However, patients may experience muscle soreness, fatigue, or temporary pain exacerbation following therapy sessions. In some cases, improper technique or overexertion can lead to injuries. Pain management strategies, particularly those involving medications, may have additional side effects such as gastrointestinal issues, drowsiness, or dependency risks.

What prior FDA approvals exist?

FDA approvals for the treatment of physical disabilities often encompass a range of therapies and medications aimed at improving mobility, strength, and overall function. For instance, medications like baclofen and botulinum toxin type A are approved for managing spasticity in conditions such as cerebral palsy. Additionally, various physical therapy techniques, including electrical stimulation and exercise programs, are commonly used to enhance muscle strength and balance. Comprehensive rehabilitation programs that integrate these therapies, along with pain management and home modifications, are also recognized for their effectiveness in improving the quality of life for individuals with physical disabilities.

What other types of research exist?

Promising novel alternatives to Integrated Health Services for physical disabilities in 2024 include: 1) Digital and telehealth-based Cognitive Behavioral Therapy (CBT) for mental health support and insomnia management, 2) Advanced robotic-assisted rehabilitation for improved motor function, 3) Virtual reality (VR) and augmented reality (AR) for immersive physical therapy, 4) Wearable technology for real-time monitoring and feedback during exercises, and 5) Multidisciplinary bio-psycho-social rehabilitation programs that integrate physical, psychological, and social support.

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Behavioural Intervention

CAPABLE Intervention for Physical Disabilities (CAPABLE-VNSNY Trial)

N/A

Waitlist Available

Led By Sarah L. Szanton, PhD, RN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Aged ≥ 65 years old

Are able to stand with or without assistance

Must not have

Do not speak English or Spanish

Have had more than 3 hospitalizations within the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20-week follow-up period

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the CAPABLE program, which helps older adults after hospitalization by providing home visits from a team of professionals. The goal is to improve their ability to live independently through personalized support and home modifications. The CAPABLE program aims to reduce the impact of disability among low-income older adults by addressing individual capacities and the home environment.

Who is the study for?

This trial is for older adults aged 65 or above who are part of the VNSNY CHOICE Medicare Plan, can stand (with help if needed), and have been out of the hospital for at least 60 days. They must struggle with daily tasks like walking or self-care but cannot be severely cognitively impaired, frequently hospitalized, undergoing cancer treatment, or planning to move within a year.

What is being tested?

The CAPABLE intervention is being tested to see if it helps improve sleep, balance, mobility, and self-care in older adults after they've been discharged from the hospital. It includes medication assistance, muscle and balance exercises, pain management strategies and home modifications.

What are the potential side effects?

Since CAPABLE involves non-medical interventions such as exercise and home safety improvements rather than drugs or surgery, side effects are minimal but may include muscle soreness from physical activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I can stand up with or without help.

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I struggle with daily self-care activities.

Exclusion Criteria

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

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I do not speak English or Spanish.

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I have been hospitalized more than 3 times in the last year.

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I am currently undergoing radiation or chemotherapy.

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I have been diagnosed with a serious brain condition that could be fatal within a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20-week follow-up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20-week follow-up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20-week follow-up period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean ADL Difficulty Score

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: InterventionExperimental Treatment1 Intervention

The experimental group will receive CAPABLE services. These include ≤10 sessions: ≤ 6 with an Occupational Therapist (OT) and ≤ 4 sessions with a Registered Nurse (RN) and up to ≤ $1,500 of home safety and home modifications from a licensed handyman who is guided by the OT. The OT and RN sessions will target participants' self-identified functional goals (e.g., getting safely into the tub, getting upstairs to sleep in own bed).

Group II: Usual CareActive Control1 Intervention

Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare.

0 / 7Eligibility 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 most common treatments for physical disabilities, particularly those involving integrated health services like comprehensive rehabilitation and support, work through several mechanisms. Physical therapy and exercise programs focus on muscle strengthening and balance training, which improve mobility and prevent falls. Pain management techniques reduce discomfort, allowing for more active participation in daily activities. Home modifications create safer environments, reducing the risk of injury. These interventions are essential for patients with physical disabilities as they collectively enhance independence, improve quality of life, and minimize the risk of further disability.

A COMBINED TREATMENT APPROACH EMPHASIZING IMPAIRMENT-BASED MANUAL THERAPY AND EXERCISE FOR HIP-RELATED COMPENSATORY INJURY IN ELITE ATHLETES: A CASE SERIES.Multidisciplinary rehabilitation after primary brain tumour treatment.Evidence-based analysis of physical therapy in Parkinson's disease with recommendations for practice and research.