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

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ClinicalTrials.gov Identifier: NCT02777060
Recruitment Status : Unknown
Verified May 2016 by Bijan Najafi, University of Arizona.
Recruitment status was:  Recruiting
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Bijan Najafi, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Diabetes Cancer Multiple Sclerosis Arthritis Parkinson's Disease Cognitive Disorders Brain Injury Stroke Procedure: Exergame Procedure: Home based balance training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures
Study Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergame
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.
Procedure: Exergame
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.
Other Name: sensor-based game like exercise training

Active Comparator: Home based balance training
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).
Procedure: Home based balance training
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 Measures :
  1. Change in Balance [ Time Frame: 4-6 weeks ]
    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 :
  1. Change in gait Speed [ Time Frame: 4-6 weeks ]
    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

  2. Change in Stride length [ Time Frame: 4-6 weeks ]
    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

  3. Change in Stride time [ Time Frame: 4-6 weeks ]
    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

  4. Change in number of walking steps per day [ Time Frame: 4-6 weeks ]
    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)

  5. Change in average of walking bout [ Time Frame: 4-6 weeks ]
    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)

  6. Change in average of standing bout [ Time Frame: 4-6 weeks ]
    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)

  7. Change in average of longest walking bout [ Time Frame: 4-6 weeks ]
    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)



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:

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

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): NCT02777060


Contacts
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Contact: Bijan Najafi, PhD 7137987536 najafi.bijan@gmail.com

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Bijan S Najafi, PhD    713-798-0477    najafi.bijan@gmail.com   
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Bijan Najafi, PhD University of Arizona

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Responsible Party: Bijan Najafi, Professor of Surgery, University of Arizona
ClinicalTrials.gov Identifier: NCT02777060     History of Changes
Other Study ID Numbers: 1409482826
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Keywords provided by Bijan Najafi, University of Arizona:
virtual reality
sensor-based balance training
gait
balance
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Brain Injuries
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurocognitive Disorders
Mental Disorders