Dizziness
Conditions
Keywords
Chronic imbalance, vestibular disorders, balance prosthesis
Brief summary
The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.
Detailed description
This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the development of assistive devices for balance disorders. The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.
Interventions
DEVICEbalance prosthesis
vibrotactile stimulation
Sponsors
Barron Associates, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.
Exclusion criteria
* Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure. * Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests. * Peripheral neuropathies of the lower extremities. * Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. | 6 weeks | The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 7/10/2009 through 6/30/2012 from Dr. Goebel's clinical practice.
Pre-assignment details
There was no run-in or washout. All participants received the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Balcap Group Each participant received Balcap Tactile prosthesis | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Balcap Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.
The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.
Time frame: 6 weeks
Population: The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balcap Group | Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. | 4.3 units on a scale | Standard Deviation 0.04 |