DiabetesNCT02214329
Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm
A study testing Sensor-based exercise training and In-home balance training in people with Diabetes, run by University of Arizona at 1 site in United States.
Trial summary
Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Sensor-based exercise training and In-home balance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic peripheral neuropathy
- Age > 50 (Men or Women)
- Able to walk 60 feet
Who cannot join
- Major lower extremity amputation
- Cognitive deficits (MMSE 24 or below)
- Severely impaired vision
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Medical Center
Tucson, Arizona, 85724
David G Armstrong, DPM, MD, PhD, 520-626-1349, dga@email.arizona.edu
Bijan Najafi, PhD, 520 626 7097, bnajafi@surgery.arizona.edu
About this study
Official title: Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes
Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral neuropathy. The exercise training has been specifically designed for DPN patients with lost lower extremity joint perception and uses state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time joint feedback through an interactive interface on a LCD monitor. The investigators hypothesize that tailored exercise with real-time visual joint feedback during exercise will reduce improve balance and gait.
Read the detailed description
The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the monitor screen; these exercises are aimed to improve weight shifting capabilities and medial-lateral movement of body.
- Conditions
- Diabetes
- Being tested
- Sensor-based exercise training, In-home balance training
- Keywords
- Postural Balance, Gait, Fall risk
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-based exercise trainingDevice
Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.
In-home balance trainingOther
The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.
| Study group | Role | What they receive |
|---|---|---|
| Sensor-based exercise training | Experimental | The intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen. Receives: Device: Sensor-based exercise training |
| In-home balance training | Active comparator | The control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data. Receives: Other: In-home balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
Postural balance is assess at baseline and post-training using body-worn sensors
Measured: 6 weeks
Gait
Gait is assessed at baseline and post-training using body-worn sensors
Measured: 6 weeks
Secondary outcomes (2)
Physical Activity
Physical activities of daily living are assessed at baseline and post-training using a T-shirt embedded body-worn sensor (PAMSys)
Measured: 6 weeks
Functional Performance
Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar National Research Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214329
- Sponsor's protocol ID
- 1100000467
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes
- ClinicalTrials.gov ID
- NCT02214329
- Acronym / sponsor ID
- 1100000467
- Conditions
- Diabetes
- Keywords
- Postural Balance, Gait, Fall risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Qatar National Research Fund
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral neuropathy. The exercise training has been specifically designed for DPN patients with lost lower extremity joint perception and uses state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time joint feedback through an interactive interface on a LCD monitor. The investigators hypothesize that tailored exercise with real-time visual joint feedback during exercise will reduce improve balance and gait.
Detailed description
The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the monitor screen; these exercises are aimed to improve weight shifting capabilities and medial-lateral movement of body.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor-based exercise training | Experimental | Device: Sensor-based exercise trainingThe intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen. |
| In-home balance training | Active comparator | Other: In-home balance trainingThe control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic peripheral neuropathy
- Age > 50 (Men or Women)
- Able to walk 60 feet
Key exclusion criteria (3 listed)
- Major lower extremity amputation
- Cognitive deficits (MMSE 24 or below)
- Severely impaired vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor-based exercise trainingBody-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training. | Device | Sensor-based exercise training |
| In-home balance trainingThe control group performs similar exercise as intervention without sensors and with no visual feedback from sensors. | Other | In-home balance training |
Primary outcome
Postural Balance
Time frame: 6 weeks
Postural balance is assess at baseline and post-training using body-worn sensors
Gait
Time frame: 6 weeks
Gait is assessed at baseline and post-training using body-worn sensors
2 secondary outcomes
Physical Activity
Time frame: 6 weeks
Functional Performance
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-based exercise training and In-home balance training in people with Diabetes, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Balance (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014; AzTrials last refreshed its copy on 3 Nov 2026.