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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02777060
Enrollment
200
Registered
2016-05-19
Start date
2014-09-30
Completion date
2017-08-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Cancer, Multiple Sclerosis, Arthritis, Parkinson's Disease, Cognitive Disorders, Brain Injury, Stroke

Keywords

virtual reality, sensor-based balance training, gait, balance

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.

Interventions

PROCEDUREExergame

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.

PROCEDUREHome 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.

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Balance4-6 weeksBalance 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

MeasureTime frameDescription
Change in Stride length4-6 weeksStride 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 time4-6 weeksStride 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 day4-6 weeksAverage 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 gait Speed4-6 weeksGait 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 average of standing bout4-6 weeksDaily 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 bout4-6 weeksDaily 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)
Change in average of walking bout4-6 weeksDaily 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)

Countries

United States

Contacts

Primary ContactBijan Najafi, PhD
najafi.bijan@gmail.com7137987536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026