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Behavioural Intervention

Planning, Reminders, and Micro-Incentives for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Northeastern University

Eligibility Criteria Checklist

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

Must have

Aged 65-80 years

No brain bleeds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial aims to compare the effectiveness of a planning, reminders, and micro-incentives intervention to regular health education on increasing physical activity in older adults who have previously experienced a non-penetrating

Who is the study for?

This trial is for older adults who have had a mild or moderate non-penetrating traumatic brain injury (TBI). They must be able to exercise, not on central nervous system medications, and willing to attend baseline testing at Northeastern University. Specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The study compares the effectiveness of a special program with planning, reminders, and small rewards against standard health education in increasing physical activity over 12 weeks. Participants will use FitBit trackers and record their walking activities.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like planning assistance, reminders, micro-incentives, and health education rather than drugs or invasive procedures, significant side effects are not expected.

Eligibility Criteria

Inclusion Criteria

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

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I am between 65 and 80 years old.

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I have not had any bleeding in my brain.

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I have not been diagnosed with a neurological disease.

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I can walk without pain or help from devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of number of minutes walking per week and total number of steps per week

Number of planned walks completed

Secondary outcome measures

Functional connectivity of the anterior mid cingulate cortex, the dorsolateral and medial prefrontal cortex and diffusion metrics of the corpus callosum and association fiber tracts of the temporal and frontal lobes

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Planning, Reminders, and Micro-IncentivesExperimental Treatment1 Intervention

Group II: Health EducationActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brandeis UniversityOTHER

21 Previous Clinical Trials

13,867 Total Patients Enrolled

Northeastern UniversityLead Sponsor

88 Previous Clinical Trials

61,250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"To be eligible for inclusion in this medical study, patients must have experienced traumatic brain injury and fall within the age range of 65 to 80. The trial aims to recruit approximately 60 suitable participants."

Answered by AI

Is this clinical trial currently accepting new participants?

"Indeed, the details on clinicaltrials.gov indicate that this particular study is actively seeking individuals to participate. The trial was initially posted on January 16th, 2024 and was most recently revised on the same day. A total of 60 patients are required for enrollment at a single site."

Answered by AI

Are individuals who are 60 years and older eligible for enrollment in this medical study?

"Individuals aged above 65 and below 80 are eligible for enrollment in this clinical trial."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently in the process of enrolling participants. The trial was initially posted on January 16, 2024 and was last updated on the same date. It aims to recruit a total of 60 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Walking After Traumatic Brain Injury in Older Adults

Timothy Morris 2024. "Walking After Traumatic Brain Injury in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222502.

All > Paid Studies Boston > Traumatic Brain Injury