Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Heart and Blood Diseases

Wounds and Injuries

Immune System Diseases

Skin and Connective Tissue Diseases

Infections

Mouth and Tooth Diseases

Rare Diseases

Diabetes Mellitus

Inflammation

Syndrome

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Osteoporosis

Crohn Disease

Intestinal Diseases

Inflammatory Bowel Diseases

Gout

Brain Neoplasms

Parkinson Disease

Obesity

Heart Failure

Spinal Cord Injuries

Asthma

Stroke

Dermatomyositis

Paralysis

Myocardial Infarction

Hypertension

Heart Diseases

Osteoarthritis

Aneurysm

Lung Neoplasms

Arthritis

Arthritis, Psoriatic

Epilepsy

Sclerosis

Lung Diseases

Psoriasis

Eczema

Multiple Sclerosis

Angina Pectoris

Angina, Unstable

Peripheral Arterial Disease

Peripheral Vascular Diseases

Liver Diseases

Apnea

Sleep Apnea Syndromes

Scleroderma, Systemic

Scleroderma, Diffuse

Heart Defects, Congenital

Headache

Arthritis, Rheumatoid

Spondylitis

Fibrosis

Arrhythmias, Cardiac

Arthritis, Juvenile

Bell Palsy

Facial Paralysis

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Cystic Fibrosis

Hydrocephalus

Muscular Dystrophies

Connective Tissue Diseases

Fibromyalgia

Myofascial Pain Syndromes

Spondylarthritis

Heart Valve Diseases

Ataxia

Cerebellar Ataxia

Myositis

Meningitis

Cluster Headache

Alopecia

Alopecia Areata

Tension-Type Headache

Craniocerebral Trauma

Undifferentiated Connective Tissue Diseases

Spondylitis, Ankylosing

Polymyositis

Granulomatosis with Polyangiitis

Axial Spondyloarthritis

Polymyalgia Rheumatica

Giant Cell Arteritis

Arteritis

Guillain-Barre Syndrome

Neurocutaneous Syndromes

Polychondritis, Relapsing

Hyperostosis

Hyperostosis, Diffuse Idiopathic Skeletal

Intracranial Aneurysm

Vascular Diseases

Infarction

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Shilpa Venkatachalam, PhD

Laura Stradford, MPH

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

We have established a governance structure with highly engaged patients and stakeholders who will serve on a Patient Governor Group (PGG) and Research Advisory Board (RAB) to ensure Patient Power participant privacy and transparency about research activities. Online tools and a mobile application at me securely capture patient data. The software tools built include real-time connection to the adaptive version of NIH Patient Reported Outcomes Measurement Information System (PROMIS) instruments capturing patient reported data that minimizes participant burden and allows participants to immediately view their scores if they choose. The Patient Power App runs on both web browsers and smartphones with data stored in the Amazon Web Services (AWS) cloud, not on a participant's smartphone or browser. The App has four key design pillars: (1) Patient engagement, community integration and education by incorporating GHLF bloggers and chronic disease news and social media engagement to the app for education, support and research findings to be shared directly and immediately with those living with registry-eligible chronic conditions; (2) Personal longitudinal health and medication tracking by providing participants' access to their actively contributed patient reported outcome (PRO) and other health-related data (e.g. current and past medications). We will use messaging to encourage participants to regularly update their information, including medication information. For example, we may remind participants to contribute their medication information with the following message: "You don't have any active medications. You can record your medications in Patient Power. By adding your active medications, you will be able to see how your symptoms have changed since starting a new medication. Click here to start entering medications". (3) Health care decision making by allowing App users to share health tracking reports at their discretion with their providers or caregivers; and (4) Research opportunities by providing a platform where an array of new research opportunities can be browsed by participants to combat chronic diseases. The combination of solid governance structure with well-developed policies and procedures, engaged patient community, collaborative relationships with many research partners and our innovatively convenient and mobile approach to data collection make Patient Power a unique and powerful patient-led initiative in chronic disease research.

PatientSpot Formerly Known as ArthritisPower

University of Alabama at Birmingham

Global Healthy Living Foundation

Director, Patient-Centered Research Operations and Ethical Oversight

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Kidney Failure, Chronic

Renal Insufficiency

Frailty

Mobility Limitation

Neurodegenerative Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Atherosclerosis

Arteriosclerosis

Arterial Occlusive Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

This group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study.

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO

MBB AFO

Subjects will be provided with a pair of New Balance 813 shoes

Control

The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults.

Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events

Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage

OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)

The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question ("How many hours per day did you wear the prescribed footwear?").

Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance.

Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA).

Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event.

The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., "I feel more stable when standing," and "I feel more stable when walking"). Perceived ease of use was assessed using two questions (i.e., "Was easy to take on and off," and "Was comfortable to wear"). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including "strongly disagree," "disagree," "somewhat disagree," "somewhat agree," "agree," and "strongly agree," respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes.

stride velocity measured in single-task walking with normal speed

stride time measured in single task walking with normal speed

stride length measured in single-task walking with normal speed

Orthotic Holdings, Inc.

Bijan Najafi, PhD

Professor of Surgery

Incident of falls related to footwear/AFO, pain, and other relevant adverse events such as callus, foot ulcers, etc

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Control: Subjects will be provided with a pair of New Balance 813 shoes

No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Prof.Bijan Najafi

Repeated measures to compare changes in two groups from baseline to 6 months

Baseline

@6Month

Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data

Hip Sway Change From Baseline to 6 Months

Repeated measures to compare the changes in both groups from baseline to 6 months

Ankle Sway Change From Baseline to 6 Months

Center of Mass (COM) Sway Change Baseline to 6 Months

Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))

Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.

@12Month

Some participants in AFO and No AFO groups withdrew from study in 6 and 12 months. Generalized Estimating Equation Analysis can handle such missing data

Fall Incidents

Repeated measures to compare the changes between groups from baseline to 6 months

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) : Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PatientSpot Formerly Known as ArthritisPower	NCT03840928	Rheumatoid Arth... Ankylosing Spon... Fibromyalgia Gout Crohn Disease Juvenile Idiopa... Lupus Erythemat... Myositis Osteoarthritis Osteoporosis Psoriasis Psoriatic Arthr... Scleroderma Dermatomyositis Inflammatory Bo... Polymyositis Axial Spondyloa... Diffuse Idiopat... Polymyalgia Rhe... Giant Cell Arte... Temporal Arteri... Wegener Relapsing Polyc... Undifferentiate... Spinal Cord Inj... Alzheimer Disea... Amyotrophic Lat... Ataxia Bell Palsy Brain Tumor Cerebral Aneury... Epilepsy Guillain-Barre ... Headache Head Injury Hydrocephalus Lumbar Disc Dis... Meningitis Multiple Sclero... Muscular Dystro... Neurocutaneous ... Parkinson Disea... Stroke Cluster Headach... Tension-Type He... Chronic Obstruc... Asthma Lung Cancer Cystic Fibrosis Sleep Apnea Eczema Alopecia Chronic Inflamm... Unstable Angina Heart Attack Heart Failure Arrythmia Valve Heart Dis... High Blood Pres... Congenital Hear... Peripheral Arte... Diabetes Chronic Liver D... Obesity		19 Years -	Global Healthy Living Foundation
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO	NCT02819011	Accidental Fall... Fall Due to Los... High Risk of Fa... Diabetes Arthritis Cancer Peripheral Arte... Parkinson's Dis... End Stage Renal...	MBB AFO Control	65 Years -	Baylor College of Medicine
EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality	NCT03987633	Atrial Fibrilla... Coronary Heart ... Cardiovascular ... Heart Failure Hypertension Peripheral Arte... Stroke, Ischemi... Asthma Chronic Obstruc... Obesity Cancer Chronic Kidney ... Diabetes Mellit... Dementia Depression Epilepsy Mental Health D... Rheumatoid Arth... Blood Pressure		6 Years -	Future Genetics Limited
An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study	NCT01460264	Chronic Obstruc... Cardiovascular ... Lung Cancer		45 Years - 75 Years	Region Skane

Spots Global Cancer Trial Database for peripheral arterial disease