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

NCT02777060 | Unknown

• 1 other identifier: 1409482826
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  4-6 weeks

Secondary Outcomes (7)

• Change in gait Speed

  4-6 weeks

• Change in Stride length

  4-6 weeks

• Change in Stride time

  4-6 weeks

• Change in number of walking steps per day

  4-6 weeks

• Change in average of walking bout

  4-6 weeks

Study Arms (2)

Exergame

EXPERIMENTAL

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

Home based balance training

ACTIVE COMPARATOR

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

Interventions

Exergame PROCEDURE

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.

Also known as: sensor-based game like exercise training

Exergame

Home based balance training PROCEDURE

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.

Home based balance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• conditions not related to specific disorders affecting balance and gait

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Neoplasms; Multiple Sclerosis; Arthritis; Parkinson Disease; Cognitive Dysfunction; Brain Injuries; Stroke

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bijan Najafi, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bijan Najafi, PhD

CONTACT

7137987536; najafi.bijan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: May 19, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

US (1)