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Accessing Mobility Using Wearable Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04306588
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Michael Debakey Veterans Affairs Medical Center
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.
Other: Exercise
Participants are undergoing a 12 weeks tele-rehabilitation program.
Other Name: Tele-rehabilitation




Primary Outcome Measures :
  1. 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


  2. 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.

  3. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. Change from baseline functional performance at 12 weeks [ Time Frame: Baseline to 3 months ]
    Functional Performance using 6 minute walk distance (6MWD) test

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any individual 18 years old or 65+ older is eligible to participate. Must be diagnosed with a chronic illness such as COPD or CHF and should be refereed to one of the tele-rehabilitation program offered at VA-Houston.

We will be enrolling veteran subjects

Exclusion Criteria:

  • Subjects will be excluded if they were non-ambulatory (unable to walk with or without assistance a distance of at least 10 meter) and were unlikely to fully comply with the protocol (e.g., long-distance travel if multiple follow-up visits are required), or if they were unwilling to provide informed consent. Patients with be also excluded if they have severe visual and hearing problems who may not be able to interact with tele-rehabilitation. Other exclusion criteria include unstable medical region (those who may change medication over next 12 weeks), those with severe cognitive impairment and psychiatric problems who may not be able to follow tele-rehabilitation instructions based on judgement of clinical investigators, those who are participating in another active intervention that may affect cognitive-motor performance, and those who do not have capacity to consent

We will not exclude patients with internal devices such as a deep brain stimulator or electronic devices for pain management, but we will not be placing our Bioharness device in people with such conditions.


Information from the National Library of Medicine

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


Contacts
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Contact: Maria Noun 713-798-7537 maria.noun@bcm.edu
Contact: Ilse Torres 713-798-8714 ilse.torresruiz@bcm.edu

Locations
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United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Bijan Najafi, PhD    713-798-7536    bijan.najafi@bcm.edu   
Contact: Maria Noun    713-798-7537    maria.noun@bcm.edu   
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         
Sponsors and Collaborators
Baylor College of Medicine
Michael Debakey Veterans Affairs Medical Center
Investigators
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Principal Investigator: Bijan Najafi, PhD Baylor College of Medicine

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Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04306588    
Other Study ID Numbers: 40765
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
COPD
CHF
Cardiovascular Diseases
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases