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An Engineering-Based Balance Assessment and Training Platform (BATP)

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ClinicalTrials.gov Identifier: NCT03994770
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury.

Condition or disease Intervention/treatment Phase
Balance Deficits Stroke Diagnostic Test: Balanced Reach Assessment and Training Protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Once the BATP is developed 20 stroke subjects will be recruited and the BATP's Assessment Module will be administered in order to verify its operation. After this is complete 10 stroke subjects will be randomly selected from this group and will undergo three one-hour training sessions over the course of one week to assess the operation of the BATP's Training Module.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Engineering-Based Balance Assessment and Training Platform
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
STR
Older people who have suffered a stroke
Diagnostic Test: Balanced Reach Assessment and Training Protocol
Three one-hour training sessions for one week in the Balanced Reach Training Protocol




Primary Outcome Measures :
  1. Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD) [ Time Frame: Assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week ]
    Measure of Balance Capability. Root Mean Squared Deviation (RMSD) records the root mean squared distance between the ground plane projection of whole-body Center of Mass and the center of the Base of Support during performance of the balanced reach task, in centimeters. It ranges from zero to the distance from the center of the Base of Support to the boundary of the Base of Support. Larger deviations indicate better performance than smaller deviations.


Secondary Outcome Measures :
  1. Multi-Directional Reach Test [ Time Frame: Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week) ]
    Measures ability to lean and reach. Multi-Directional Reach Test records the distance in centimeters that one can reach in the forward, backward, rightward, and leftward directions; by bending at the waist and reaching with arm extended in each associated direction. Larger distances indicate better performance than smaller distances.

  2. Falls Efficacy Scale [ Time Frame: Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week) ]
    Assesses fear of falling. The Falls Efficacy Scale is a self-report questionnaire providing information on level of concern about falls for a range of activities of daily living. The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned). The overall score is the sum of the 16 scores that are provided and ranges from 1to 64. Overall scores between 16-19 indicate low fear of falling; 20-27 indicates moderate fear of falling; and 28-64 indicates high fear of falling. Lower scores are better than higher scores.



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Ages Eligible for Study:   65 Years to 86 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke with residual hemiparetic gait
  • Adequate language and neurocognitive function to participate in testing and training
  • Able to give adequate informed consent
  • Completion of all regular physical therapy
  • Capable of performing the BATP Assessment and Training tasks without assistive devices or handholds
  • Able to tolerate the use of AVR eyewear for ~10 minutes

Exclusion Criteria:

Clinical history of:

  • unstable angina
  • recent myocardial infarction (< 3 month) or hemodynamically significant congestive heart failure (NYHA II) or valvular dysfunction
  • peripheral arterial occlusive disease with claudication
  • major orthopedic, chronic pain, or conditions restricting exercise
  • pulmonary or renal failure
  • Body Mass Index (BMI) >40
  • active vertigo
  • symptomatic orthostatic hypotension
  • poorly controlled hypertension (>190/105) on at least two separate occasions
  • poorly controlled type 1 or 2 diabetes (HbA1c >10)
  • recent hospitalization for severe disease or surgery (<3 month)
  • excessive daily alcohol consumption (>3 oz. liquor; >12 oz. wine; or >36 oz. beer) or illicit drug abuse
  • untreated major clinical depression or dementia
  • major neurological disease other than stroke, such as Parkinson's disease, multiple sclerosis, etc.
  • any condition (e.g., extreme obesity or frailty) that would preclude safe completion of the BATP

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): NCT03994770


Contacts
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Contact: Joseph E Barton, MD PhD (202) 337-5921 jbarton@som.umaryland.edu

Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Joseph E Barton, MD PhD    202-337-5921    jbarton@som.umaryland.edu   
Principal Investigator: Joseph E. Barton, MD PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Joseph E. Barton, MD PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03994770     History of Changes
Other Study ID Numbers: A3020-P
I21RX003020 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 VA Office of Research and Development:
Balance