What side effects are associated with this type of intervention?

Common treatments for Acquired Brain Injury (ABI) that focus on symptom self-management through activity planning and pacing, such as those studied in the Parkwood Pacing and Planning™ app, generally aim to help patients manage their daily activities to avoid symptom exacerbation. Known side effects of these treatments are minimal but can include frustration or anxiety related to the strict adherence to activity limits and the potential for underestimating or overestimating one's capabilities, which can lead to either overexertion or reduced activity levels. Overall, these approaches are considered safe and beneficial for managing ABI symptoms.

What prior FDA approvals exist?

There are limited FDA-approved pharmacological treatments specifically for Acquired Brain Injury (ABI). However, some medications used for managing symptoms related to ABI, such as attention and concentration difficulties, include CNS stimulants like methylphenidate and amphetamines. These drugs are often used off-label to help improve cognitive function and behavioral issues in ABI patients. Non-pharmacological interventions, such as cognitive rehabilitation and activity planning tools like the Parkwood Pacing and Planning™ app, are also crucial in managing ABI symptoms. These approaches focus on helping patients manage their daily activities and improve their quality of life through structured planning and pacing.

What other types of research exist?

<ol> <li>Virtual Reality (VR) Interventions: VR systems like the VMall, which simulate real-world tasks in a controlled environment, can help ABI patients improve multitasking and cognitive functions through immersive and interactive experiences. 2.</li> </ol> Telemedicine Platforms: Enhanced telemedicine services that offer personalized care plans, remote monitoring, and real-time adjustments based on patient feedback can provide comprehensive support for ABI patients. 3. Augmented Reality (AR) Guided Training: AR-guided exercises and activities can help improve functional mobility and cognitive skills by overlaying digital information onto the real world, making rehabilitation more engaging and effective. 4. Computerized Cognitive Training Programs: These programs use adaptive algorithms to tailor cognitive exercises to the patient's current abilities, providing targeted and progressive challenges to improve cognitive function. 5. Mobile Health (mHealth) Apps: Advanced mHealth apps that integrate machine learning and data analytics to personalize activity planning and pacing based on real-time symptom tracking and user behavior data.

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Pacing and Planning App for Traumatic Brain Injury

N/A

Recruiting

Led By Dalton Wolfe, PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Experienced a mild traumatic brain injury/concussion

Must not have

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the MyBrainPacer™ app, which helps people with post-concussion syndrome manage their daily activities using a point system. The app assigns points to activities based on how much energy they require and how severe the symptoms they might trigger. This helps users avoid overexertion and manage their symptoms more effectively.

Who is the study for?

This trial is for adults who've had a mild traumatic brain injury or concussion, diagnosed by a healthcare professional. Participants must have access to a smartphone or tablet and be able to use English for reading and writing. It's not suitable for those without this type of injury, unwilling to share their diagnosis details, under 18, without device access, or unable to understand English.

What is being tested?

The Parkwood Pacing and Planning™ app is being tested. This app helps users manage symptoms after a concussion by assigning points for daily activities based on symptom severity. The study aims to enhance the app with personalized features using data analytics and machine learning.

What are the potential side effects?

Since this intervention involves using an application rather than medication, traditional side effects are not expected. However, users may experience frustration if they find the app difficult to use or if it does not meet their expectations in managing symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had a mild concussion.

Exclusion Criteria

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

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I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Changes in general well-being

Symptom changes

Secondary study objectives

Change in daily activities and symptoms

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pacing and Planning AppExperimental Treatment1 Intervention

The Pacing and Planning Program is a points system to aid individuals with an acquired brain injury/concussion in planning daily activities and managing symptoms. Activities are allotted various points, depending on the energy the task requires and the symptoms they create. Activities can include anything from grocery shopping to driving or watching TV, etc. Patients are allotted a number of points for a day, and therefore learn to sparingly perform activities. This results in a reduction of symptoms and improved recovery time.

0 / 3Eligibility 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 Parkwood Pacing and Planning™ app uses a point system to help patients with Acquired Brain Injury (ABI) manage their symptoms by planning and pacing their daily activities. This approach is based on the principle of balancing activity and rest to prevent symptom exacerbation. The mechanism of action involves monitoring symptom severity and assigning a daily point maximum, which guides patients in scheduling their activities to stay within their limits. This method helps in reducing cognitive and physical fatigue, promoting gradual recovery, and preventing setbacks. For ABI patients, this is crucial as it empowers them to take control of their rehabilitation process, leading to improved outcomes and quality of life.