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Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures

Primary Purpose

Diabetes, Cancer, Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergame
Home based balance training
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring virtual reality, sensor-based balance training, gait, balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of:

  • diabetes
  • cancer
  • multiple sclerosis
  • arthritis
  • Parkinson's disease
  • cognitive disorders
  • brain injury
  • frailty
  • stroke

Exclusion Criteria:

  • conditions not related to specific disorders affecting balance and gait

Sites / Locations

  • University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exergame

Home based balance training

Arm Description

inertial sensor based system (wearable sensors, LEGSys, Biosensics LLC) will be used for balance training with computerized feedback. The balance training program is focused on lower extremities including ankle joint exercise and virtual obstacle crossing tasks.

The control group will ask to perform a home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback. Exercises include postural balance tasks, such as backward and forward weight shifting, as well as dynamic balance exercises, such as marching in place (comparable to virtual obstacle crossing in experimental group).

Outcomes

Primary Outcome Measures

Change in Balance
Balance will be quantified by measuring area of sway of center of mass (with unit of cm2) during quite standing according to Romberg's protocol and using validated instrument (BalanSens, Biosensics, MA, USA)

Secondary Outcome Measures

Change in gait Speed
Gait Speed (with unit of m/sec) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Change in Stride length
Stride Length (with unit of meter) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Change in Stride time
Stride time (with unit of second) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Change in number of walking steps per day
Average of walking steps (no unit) per day will be measured during 48 hours of daily physical activity monitoring using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Change in average of walking bout
Daily average of walking bout (continuous walking without stop, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Change in average of standing bout
Daily average of standing bout (continuous standing without changing in posture with unit of seconds) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Change in average of longest walking bout
Daily average of longest walking bout (longest continuous walking without stop per day, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)

Full Information

First Posted
June 8, 2015
Last Updated
May 16, 2016
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02777060
Brief Title
Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures
Official Title
Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Explore the benefit of the game-based virtual reality system in improving lower extremity kinematics and balance in patients suffering from disease/disorders including Diabetes, Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain Injury, Stroke or Frailty. A four to six weeks of training with 2 training session/week will be provided.
Detailed Description
Individuals suffering from certain disorders/diseases including diabetes, arthritis, cancer, osteoarthritis, stroke, Parkinson's disease, cognitive impairment or brain Injury are more likely to experience a fall or a fall-related injury than healthy individuals during to impaired postural stability or diminished joint perception. Under certain circumstance they may also experience pain, depression, anxiety, and a decreased quality of life. The investigators' research has been designed to provide exercise training using non-invasive body-worn sensors (similar to those used in an iPhone®) to provide real-time visual information about joint motion in a virtual environment. These sensors will be worn using a vest, t-shirt or elastic band. The investigators will, 1) assess changes in participant's perception of lower extremity position while they perform these exercises; 2) motivate and guide simple exercise performance in the clinic/home, using an interactive game-like scheme; and 3) assess changes in participant's postural stability and gait as a result of provided exercise training. The information gathered will provide new understanding about more helpful rehabilitation strategies that improve postural stability in patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Cancer, Multiple Sclerosis, Arthritis, Parkinson's Disease, Cognitive Disorders, Brain Injury, Stroke
Keywords
virtual reality, sensor-based balance training, gait, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exergame
Arm Type
Experimental
Arm Description
inertial sensor based system (wearable sensors, LEGSys, Biosensics LLC) will be used for balance training with computerized feedback. The balance training program is focused on lower extremities including ankle joint exercise and virtual obstacle crossing tasks.
Arm Title
Home based balance training
Arm Type
Active Comparator
Arm Description
The control group will ask to perform a home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback. Exercises include postural balance tasks, such as backward and forward weight shifting, as well as dynamic balance exercises, such as marching in place (comparable to virtual obstacle crossing in experimental group).
Intervention Type
Procedure
Intervention Name(s)
Exergame
Other Intervention Name(s)
sensor-based game like exercise training
Intervention Description
Subjects will perform progressive and computerized foot and ankle exercises which include weight shifting, ankle reaching task while standing, and virtual obstacle crossing task (i.e. balancing on single leg) using wearable sensors technology (Exergaming) equipment). Subjects will perform these exercises for 4-6 weeks, twice per week. The duration of exercise per session is anticipated to be 30-45 minutes.
Intervention Type
Procedure
Intervention Name(s)
Home based balance training
Intervention Description
Subjects in the control group will ask to perform a standard home based balance program for 4-6 weeks. The home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback and Exergaming equipment.
Primary Outcome Measure Information:
Title
Change in Balance
Description
Balance will be quantified by measuring area of sway of center of mass (with unit of cm2) during quite standing according to Romberg's protocol and using validated instrument (BalanSens, Biosensics, MA, USA)
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Change in gait Speed
Description
Gait Speed (with unit of m/sec) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Time Frame
4-6 weeks
Title
Change in Stride length
Description
Stride Length (with unit of meter) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Time Frame
4-6 weeks
Title
Change in Stride time
Description
Stride time (with unit of second) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
Time Frame
4-6 weeks
Title
Change in number of walking steps per day
Description
Average of walking steps (no unit) per day will be measured during 48 hours of daily physical activity monitoring using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Time Frame
4-6 weeks
Title
Change in average of walking bout
Description
Daily average of walking bout (continuous walking without stop, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Time Frame
4-6 weeks
Title
Change in average of standing bout
Description
Daily average of standing bout (continuous standing without changing in posture with unit of seconds) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Time Frame
4-6 weeks
Title
Change in average of longest walking bout
Description
Daily average of longest walking bout (longest continuous walking without stop per day, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
Time Frame
4-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of: diabetes cancer multiple sclerosis arthritis Parkinson's disease cognitive disorders brain injury frailty stroke Exclusion Criteria: conditions not related to specific disorders affecting balance and gait
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bijan Najafi, PhD
Phone
7137987536
Email
najafi.bijan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijan S Najafi, PhD
Phone
713-798-0477
Email
najafi.bijan@gmail.com

12. IPD Sharing Statement

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Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures

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