Accessing Mobility Using Wearable Sensors
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|ClinicalTrials.gov Identifier: NCT04306588|
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention.
Our specific aims are twofold, first we aim to explore whether and how a clinical condition such as Chronic obstructive pulmonary disease (COPD) or Congestive Heart Failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (e.g., LEGSys, BalanSENS, and Frailty Meter). Second, we will explore whether an exercise intervention provided via tele-medicine (tele-rehabilitation) can enhance motor-cognitive performance.
|Condition or disease||Intervention/treatment||Phase|
|COPD Pulmonary Disease Pulmonary Restrictive Disease Congestive Heart Failure Cardiovascular Diseases||Other: Exercise||Phase 1 Phase 2|
Our specific research questions: (1) Which motor-cognitive parameters measurable by wearable sensors (e.g. gait, balance, frailty index, etc) are linked to specific diseases (e.g. COPD, CHF) (2) Which motor-cognitive parameters are most responsive to identify changes in patients ambulatory performance related to Tele-rehabilitation
We will recruit a minimum of 15 per clinical condition with a maximum of 150 per clinical condition in subjects suffering from different disorders, which may impact motor-cognitive. Targeted disorders: COPD and CHF. Other chronic illness may also be recruited such as Diabetes, Peripheral Arterial Disease, Morbus Parkinson, Cancer, Neuropathy, Frailty, Mild Cognitive Impairment, Depression, and patients undergoing major surgical intervention. Fifteen or more people with the same disorder would form a group.
We will measure motor-cognitive performance from each subject. For this purpose several sensors will be attached to the body using elastic straps. Each subject will be asked to dedicate approximately 1 hour of their time for each visit. A series of health related questionnaires will be used to evaluate the quality of life, clinical problems, cognition, and pain intensity levels, respectively. Medical history (from the subject's chart) and demographic information will be obtained.
This study consists of Core and Ancillary Measurements. Core Measurements (Motor cognitive test) will be performed during all visits whereas Ancillary Measurements may not be required for anyone.
If the subject is undergoing tele-rehabilitation intervention, which may also benefit functional status (e.g. improvement in balance), we will re-examine motor-cognitive performance using the test described above to evaluate the sensitivity of the proposed test in tracking outcomes in response to the intervention or predict outcomes based on baseline assessments. Specifically, depending on the type of intervention and frequency of standard of care visits for follow-up at the clinic, we may re-assess functional performance at each follow-up standard of care visit, upon the availability of the subject. Please note that the number of follow up visits will not exceed 12 visits over the course of 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accessing Mobility Quality Using Wearable Sensors|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||March 30, 2022|
Experimental: Tele-rehabilitation exercise Group
Participants who are suffering from a chronic illness such as COPD or CHF and are referred for tele-rehabilitation intervention at the VA-Houston will be qualified for the purpose of this study.
Participants are undergoing a 12 weeks tele-rehabilitation program.
Other Name: Tele-rehabilitation
- Change from baseline gait speed at 12 weeks [ Time Frame: Baseline and 3 months ]
Gait change from Baseline to 12 weeks
We will quantify gait speed using a validated wearable device, called LEGSys
- Change from baseline balance at 12 weeks [ Time Frame: Baseline and 3 months ]Balance will be quantified by measuring body sway during still upright standing for duration of 30 seconds. We will use a validated wearable device, called BALANSens to measure body sway.
- Change from baseline frailty index at 12 weeks [ Time Frame: Baseline and 3 months ]Physical frailty is quantified by frailty index (FI). FI will be measured using a validated wearable device, called Frailty meter (FM).
- Change from baseline Fear of Falling at 12 weeks [ Time Frame: Baseline and 3 months ]Fear of falling is assessed using Fall Efficacy Scale International (FES-I) questionnaire. Scores range from 16 (no concern about falling) to maximum 64 (severe concern about falling).
- Change from baseline depression at 12 weeks [ Time Frame: Baseline and 3 months ]Depression will be assessed using Center of Epidemiologic Depression Scale (CES-D) questionnaire. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression.
- Change from baseline cognitive performance at 12 weeks [ Time Frame: Baseline to 3 months ]Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
- Change from baseline functional performance at 12 weeks [ Time Frame: Baseline to 3 months ]Functional Performance using 6 minute walk distance (6MWD) test
- Change from baseline Risk of falling at 12 weeks [ Time Frame: Baseline and 3 months ]Risk of falling will be assessed using timed Up and Go test
- Change from baseline motor capacity at 12 weeks [ Time Frame: Baseline and 3 months ]Motor capacity will be assessed by 5 times sit to stand test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306588
|Contact: Maria Nounemail@example.com|
|Contact: Ilse Torresfirstname.lastname@example.org|
|United States, Texas|
|Michael E. DeBakey Veterans Affairs Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bijan Najafi, PhD 713-798-7536 email@example.com|
|Contact: Maria Noun 713-798-7537 firstname.lastname@example.org|
|Sub-Investigator: Amir Sharafkhaneh, MD PHD|
|Sub-Investigator: Charlie Lan, MD|
|Sub-Investigator: Monthaporn Bryant, PhD|
|Sub-Investigator: Christina Nguyen, RRT|
|Sub-Investigator: Venkata Bandi, MD|
|Principal Investigator:||Bijan Najafi, PhD||Baylor College of Medicine|