Group Wellness Interventions for Neurologic Conditions

Overseen By Brionna Robinson, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Stroke, Neurological disease, Seizures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

360 Participants Needed

Trial Summary

What is the purpose of this trial?

Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Group Wellness Interventions for Neurologic Conditions?

Research shows that various evidence-based interventions, such as group therapy and education, can improve outcomes and quality of life for patients with neurological conditions. These interventions help with symptom management, enhance motor and cognitive functions, and support vocational reintegration. ^{1 2 3 4 5}

Is the Group Wellness Intervention for Neurologic Conditions safe for humans?

Research on similar group wellness interventions for neurological conditions shows they are generally safe, with no adverse events reported in a study of an exercise program for older adults with chronic neurological conditions. ^{6 7 8 9 10}

How is the Group Wellness Interventions treatment different from other treatments for neurological conditions?

The Group Wellness Interventions treatment is unique because it focuses on group classes that combine social support, individualized programming, and experiential learning, which are not typically emphasized in standard neurological treatments. This approach aims to improve physical and social well-being, which can be particularly beneficial for managing chronic neurological conditions. ^{4 7 8 11 12}

Eligibility Criteria

This trial is for adults aged 18-64 with mild or severe TBI at least a few months post-injury, and those 65+ with ADRD at least one year post-diagnosis. Participants must speak English fluently and have a support person willing to join the study. Excluded are individuals with significant neurological history other than their condition, uncontrolled seizures, recent psychiatric hospitalization, or substance abuse affecting daily functions.

Inclusion Criteria

I am a support person for someone with TBI or ADRD and can participate in English.

I am 65 or older with Alzheimer's, diagnosed over a year ago, speak English, and have a supportive participant.

I am 18-64 with a mild TBI over 3 months ago, speak English, and have a supportive person.

Exclusion Criteria

I have Alzheimer's or related dementia without recent severe psychiatric issues, uncontrolled seizures, or substance misuse.

I have mild TBI without past stroke, uncontrolled seizures, recent severe psychiatric issues, or substance misuse affecting daily life.

As a support person, I have no major neurological issues, uncontrolled seizures, recent psychiatric hospitalizations, or substance use that affects daily functions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two different online group wellness treatments designed to improve self-efficacy and quality of life

12 weeks

Online sessions

Follow-up

Participants are monitored for changes in self-efficacy and life satisfaction after treatment

6 months

Treatment Details

Interventions

• Group Wellness Class 1
• Group Wellness Class 2

Trial Overview The study compares two group wellness programs designed for people living with chronic mild to severe traumatic brain injuries (TBI) or Alzheimer's disease-related dementias (ADRD), along with their support persons. The goal is to evaluate which program better promotes long-term wellness in these populations.

Participant Groups

Group I: Group Wellness Class 1 Experimental Treatment 1 Intervention

Group II: Group Wellness Class 2 Active Control 1 Intervention

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Rehabilitation Hospital of Indiana

Collaborator

Trials

13

Recruited

5,500+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Franciscan Health

Collaborator

Trials

1

Recruited

360+

Findings from Research

Evidence-based interventions in neurological rehabilitation, such as constraint-induced movement therapy (CIMT) and robot-assisted training, have significantly improved motor functions and quality of life for patients with conditions like stroke and multiple sclerosis, as demonstrated through various therapeutic strategies over the past 20 years.

Early and frequent speech and language therapy (SLT) is crucial for effective recovery from communicative disorders, with PC-assisted training enhancing outcomes, highlighting the importance of tailored rehabilitation approaches for cognitive and communicative impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[DGRW-update: neurology--from empirical strategies towards evidence based interventions]. Schupp, W.[2011]

An 8-week outpatient rehabilitation program for adults with functional neurological disorder (FND) led to significant reductions in anxiety and depression, as well as improvements in functional mobility, based on assessments of 45 patients.

Most patients showed measurable progress in various outcomes, including the Beck Anxiety Inventory and Timed Up and Go test, with continued improvements noted at a 3-month follow-up for those who attended, indicating the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine outcomes and evaluation of an 8-week outpatient multidisciplinary rehabilitative therapy program for functional neurological disorder. Guy, L., Caceres, GA., Jackson, T., et al.[2023]

A retrospective study of 148 adults with various neurological conditions showed significant improvements in motor function and overall independence after a 4-6 week intensive rehabilitation program, as measured by the Functional Independence Measure (FIM), Modified Rankin scale, and Glasgow Outcome Scale.

Despite the positive outcomes, 37.6% of patients remained unemployed six months post-discharge, indicating a need for more individualized rehabilitation programs to address cognitive gains, especially in traumatic brain injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New rehabilitation models for neurologic inpatients in Brazil. Jorge, LL., de Brito, AM., Marchi, FH., et al.[2021]

Preventing secondary complications like osteoporosis, pressure ulcers, venous thromboembolism, and heterotopic ossification is crucial for improving the long-term activity and participation of individuals recovering from neurological diseases.

Nutrition plays a significant role in functional outcomes during rehabilitation, highlighting the importance of addressing dietary needs alongside physical therapy to enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Other physical consequences of disability. Macfarlane, J.[2013]

A 16-bed rehabilitation unit was established to actively involve patients and their families in the recovery process for both non-progressive and progressive neurological disorders, with a focus on innovative practices like early home visits.

In the first two years, the unit admitted 318 patients, with 51% of those cases related to stroke, highlighting the unit's significant role in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a stroke and neurological rehabilitation unit in a district general hospital. Wood, VA., Hewer, RL.[2020]

The educational program focused on fall prevention and safe mobility did not significantly reduce the number of falls among participants with neurological conditions, as evidenced by a similar number of fallers in both the education group and control group over a 6-month follow-up.

However, participants in the education group showed significant improvements in social participation and daily living activities, scoring better on the Community Integration Questionnaire and Instrumental Activities of Daily Living scales compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational and Exercise Intervention to Prevent Falls and Improve Participation in Subjects With Neurological Conditions: The NEUROFALL Randomized Controlled Trial. Cattaneo, D., Gervasoni, E., Pupillo, E., et al.[2020]

This review aims to identify and analyze various dietary education programs for adults with neurological diseases, which affect up to 1 billion people, including conditions like Alzheimer's and Parkinson's disease.

The review will evaluate program characteristics such as duration, session length, and behavior change techniques, providing insights into effective dietary interventions recommended by the World Health Organization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary education programs for adults with neurological diseases: a scoping review protocol. Russell, RD., Black, LJ., Begley, A.[2022]

A 12-week community exercise program for older adults with chronic neurological conditions showed no adverse events and high participation rates, with participants attending 88% of sessions and completing 89% of prescribed exercises.

All evaluated participants (n = 8) experienced clinically important improvements in at least one area of physical function, such as grip strength and balance, highlighting the program's effectiveness and the importance of individualized support and social connection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating and Characterizing an Individually-Tailored Community Exercise Program for Older Adults With Chronic Neurological Conditions: A Mixed-Methods Study. Coomaran, V., Khan, A., Tyson, E., et al.[2022]

A significant increase in neurological disorder-related outpatient visits among U.S. military members from 2005 to 2010 is largely due to the introduction of new diagnostic codes for conditions like sleep disorders, pain, and headaches, which accounted for 78% of the increase.

In 2010, nearly half of all outpatient encounters for neurological disorders were attributed to 'organic sleep disorders,' highlighting the impact of these new codes on healthcare reporting and the potential for misinterpretation of true incidence rates of neurological illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between increasing outpatient encounters for neurological disorders and introductions of associated diagnostic codes, active duty military service members, 1998-2010. [2015]

A scoping review of 2555 articles identified only 13 nutrition education programs for adults with neurological diseases, indicating a significant gap in available resources for conditions like dementia, multiple sclerosis, and stroke.

Most programs lacked adherence to best practice principles in nutrition education, such as structured delivery and evaluation methods, highlighting the need for more effective and evidence-based programs to support dietary adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education Programs for Adults with Neurological Diseases Are Lacking: A Scoping Review. Russell, RD., Black, LJ., Begley, A.[2022]

In a study of 2,606 neurological patients admitted to a general ward in Brazil over 11 years, cerebrovascular diseases were the most common diagnosis, accounting for 45.8% of cases, indicating a significant prevalence of these disorders.

The brain was the most frequently affected site, involved in 66% of cases, highlighting the critical need for targeted interventions and resources for cerebrovascular conditions in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can be expected to be seen in a Neurology ward? Eleven-year experience in a Brazilian university hospital. Moreira, DG., Oliveira, EML., Coelho, FMDS., et al.[2022]

In a study of 2,410 adults with neurological conditions, it was found that individuals generally receive more informal support (like help from family and friends) than formal support (like professional care), with those suffering from Alzheimer's disease/dementia receiving the most support overall.

Stroke survivors were less likely to receive both formal and informal support services compared to individuals with other neurological conditions, indicating a potential gap in care that could be addressed to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support service utilization and out-of-pocket payments for health services in a population-based sample of adults with neurological conditions. Obembe, AO., Goldsmith, CH., Simpson, LA., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[DGRW-update: neurology--from empirical strategies towards evidence based interventions]. [2011]

2. Germany pubmed.ncbi.nlm.nih.gov

Routine outcomes and evaluation of an 8-week outpatient multidisciplinary rehabilitative therapy program for functional neurological disorder. [2023]

3. England pubmed.ncbi.nlm.nih.gov

New rehabilitation models for neurologic inpatients in Brazil. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Other physical consequences of disability. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Development of a stroke and neurological rehabilitation unit in a district general hospital. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Educational and Exercise Intervention to Prevent Falls and Improve Participation in Subjects With Neurological Conditions: The NEUROFALL Randomized Controlled Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary education programs for adults with neurological diseases: a scoping review protocol. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating and Characterizing an Individually-Tailored Community Exercise Program for Older Adults With Chronic Neurological Conditions: A Mixed-Methods Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Relationships between increasing outpatient encounters for neurological disorders and introductions of associated diagnostic codes, active duty military service members, 1998-2010. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition Education Programs for Adults with Neurological Diseases Are Lacking: A Scoping Review. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

What can be expected to be seen in a Neurology ward? Eleven-year experience in a Brazilian university hospital. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Support service utilization and out-of-pocket payments for health services in a population-based sample of adults with neurological conditions. [2018]