Vestibular DiseasesSEMDNCT01483937
Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
A study of Vestibular Diseases and Labyrinth Diseases, run by Karen L Atkins at 4 sites in United States.
Trial summary
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium. Read more about this study
- Who is it for?
- Ages 21 to 84 years
- Conditions the study is for
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reporting 2 or more falls with or without injury within the past 6 months.
- Below normal SOT containing a abnormal vestibular score.
- Potential to benefit from physical therapy as indicated by physician prescription referral.
- Able to sit and to stand unaided for 2 minutes.
- Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Who cannot join
- Fluctuating Meniere's
- Vestibular injury requiring surgery such as perilymph fistula
- Moderate progressive neurologic disease such as multiple sclerosis
- Does not speak and understand the English language
- Resides in a nursing home
- Unable to provide own consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Florida Ear & Balance Center
Celebration, Florida, 34747
Stevenson & Associates Physical Therapy
Fort Myers, Florida, 33908
England Physical Therapy
Garden Grove, California, 92840
Brooks Balance Center
Jacksonville, Florida, 32216
About this study
Official title: Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium.
Study participants will receive regular physical therapy, and some will use the SEMD device while receiving usual care vestibular-balance physical therapy. The device is an elastic belt that holds eight small battery powered vibrating disks. When using the device, you will sit or stand on a force platform that measures body sway. That movement information is sent to a computer which then sends the information to you via the vibrating disks. The vibrating disks are similar to a vibrating cell phone: you can feel the vibration but it is not uncomfortable. You can also see your sway movement on the computer screen. Some tests and activities will be paced with a beeping sound.
Read more
The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and conventional vestibular-balance physical therapy as reported by treating physical therapists' by counting number of skills acquired in a treatment session, and the amount of time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3. Determine the difference in vestibular habituation between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical therapy; 5. Determine the patient's perception of quality of life between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with SEMD and conventional vestibular-balance physical therapy .
In addition to primary and secondary outcome measurements, efficiency of skill acquisition, devised for this study, will be evaluated by tracking the number of skills and length of time needed to acquire each skill for each physical therapy session using the Patient Skill Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor). These measurements were devised for this study, and will be evaluated for informational purposes only.
Read the detailed description
This study will compare two approaches of physical therapy intervention within vestibular deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. usual care physical therapy only.
Multimodal sensory cueing gives additional or enriched information to complement postural and mobility decisions. SEMD displays combine vibrotactile, visual and audio cueing that are intuitive and non-intrusive within a balance training system.
Study intervention includes a maximum of 12 physical therapy intervention sessions, 2 times per week for 6 weeks or normalization of SOT, whichever occurs first. Usual care physical therapy prescriptions are written specific for number of sessions over a specific duration of time. Discharge from physical therapy occurs when number of sessions within a specified period of time is exhausted or goals specified by the physical therapist are met. Data collection includes 1 pre test and 4 post tests at intervals during the weeks of intervention, plus 3 follow-up phone interviews at specified intervals after intervention for maximal study duration of 6 months. A patient must attend at least 4 physical therapy intervention sessions for their data to be used and for the follow-up phone interviews to be initiated.
- Conditions
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases, Traumatic Brain Injury
- Being tested
- Usual care physical therapy plus SEMD, Usual care physical therapy only
- Keywords
- Keywords provided by BalanceSense, LLC:, Physical Therapy, Rehabilitation, Disequilibrium, Balance dysfunction or disorder, Vestibular, Mild Traumatic Brain Injury (mTBI), Vibrotactile
- Medical subject headings
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases, Brain Injuries, Traumatic, Dysequilibrium syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care physical therapy plus SEMDDevice
Also called BalanceSense
Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.
Usual care physical therapy onlyOther
Subjects will receive usual care physical therapy from vestibular and balance specialists.
| Study group | Role | What they receive |
|---|---|---|
| Usual care physical therapy only | Active comparator | Subjects will receive usual care physical therapy intervention provided by vestibular and balance specialists. Usual care physical therapy, in general, includes but is not limited to static and dynamic balance activities with or without head movements on firm floor or compliant surfaces. Receives: Other: Usual care physical therapy only |
| Usual care physical therapy plus SEMD | Experimental | Subjects will receive usual care physical therapy intervention provided by vestibular balance specialists while using the Sensory Enrichment Multimodal Device (SEMD). SEMD protocols use visual, vibrotactile, and auditory cueing referenced to subject's Center of Gravity (COG) and/or Sum of Pressure (SOP) data collected from a force platform upon which the subject is placed. Static and dynamic balance activities with or without head movement are preformed while watching a computer screen; paced with an auditory metronome; and cued by "touch" vibration via coin tactors imbedded in a belt worn around the waist matching the COG/SOP data display. Receives: Device: Usual care physical therapy plus SEMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Measured: Pre Test to Post Test 1 after two physical therapy sessions (one week)
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Measured: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Measured: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Measured: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)
Secondary outcomes (5)
Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2
Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.
Criterion Validity: "Authors support a cut off score of 23/30 for independent safe ambulation".
Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.
- 23-30 = safe ambulators
Measured: Pre Test to Post Test 2 after four physical therapy sessions within 10 days
Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1
A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)
Measured: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days
Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2
Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.
Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.
Criterion Validity: "Authors support a cut off score of 45/56 for independent safe ambulation".
Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk
Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:
- Sensitivity = 64% (Correctly predicts fallers)
- Specificity = 90% (Correctly predicts non-fallers)
Measured: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.
Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4
Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.
Measured: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days
Head Shake Sensory Organization Test (HS_SOT)
Head Shake Sensory Organization Test (HS-SOT)
HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis.
Measured: Pre Test, Post Test 1 and Post Test 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen L Atkins
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Karen L Atkins, BalanceSense LLC
- Investigators
- Karen L Atkins, PhD, PT, Study director, BalanceSense LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483937
- Sponsor's protocol ID
- 10-221:1.2
- Other IDs
- W81XWH-10-C-0184-01
- Acronym
- SEMD
- Status last verified
- Jun 2014
- First submitted
- 30 Nov 2011
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
- ClinicalTrials.gov ID
- NCT01483937
- Acronym / sponsor ID
- SEMD / 10-221:1.2
- Conditions
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases, Traumatic Brain Injury
- Keywords
- Keywords provided by BalanceSense, LLC:, Physical Therapy, Rehabilitation, Disequilibrium, Balance dysfunction or disorder, Vestibular, Mild Traumatic Brain Injury (mTBI), Vibrotactile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karen L AtkinsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium.
Study participants will receive regular physical therapy, and some will use the SEMD device while receiving usual care vestibular-balance physical therapy. The device is an elastic belt that holds eight small battery powered vibrating disks. When using the device, you will sit or stand on a force platform that measures body sway. That movement information is sent to a computer which then sends the information to you via the vibrating disks. The vibrating disks are similar to a vibrating cell phone: you can feel the vibration but it is not uncomfortable. You can also see your sway movement on the computer screen. Some tests and activities will be paced with a beeping sound.
The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and conventional vestibular-balance physical therapy as reported by treating physical therapists' by counting number of skills acquired in a treatment session, and the amount of time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3. Determine the difference in vestibular habituation between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical therapy; 5. Determine the patient's perception of quality of life between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with SEMD and conventional vestibular-balance physical therapy .
In addition to primary and secondary outcome measurements, efficiency of skill acquisition, devised for this study, will be evaluated by tracking the number of skills and length of time needed to acquire each skill for each physical therapy session using the Patient Skill Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor). These measurements were devised for this study, and will be evaluated for informational purposes only.
Detailed description
This study will compare two approaches of physical therapy intervention within vestibular deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. usual care physical therapy only.
Multimodal sensory cueing gives additional or enriched information to complement postural and mobility decisions. SEMD displays combine vibrotactile, visual and audio cueing that are intuitive and non-intrusive within a balance training system.
Study intervention includes a maximum of 12 physical therapy intervention sessions, 2 times per week for 6 weeks or normalization of SOT, whichever occurs first. Usual care physical therapy prescriptions are written specific for number of sessions over a specific duration of time. Discharge from physical therapy occurs when number of sessions within a specified period of time is exhausted or goals specified by the physical therapist are met. Data collection includes 1 pre test and 4 post tests at intervals during the weeks of intervention, plus 3 follow-up phone interviews at specified intervals after intervention for maximal study duration of 6 months. A patient must attend at least 4 physical therapy intervention sessions for their data to be used and for the follow-up phone interviews to be initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care physical therapy only | Active comparator | Other: Usual care physical therapy onlySubjects will receive usual care physical therapy intervention provided by vestibular and balance specialists. Usual care physical therapy, in general, includes but is not limited to static and dynamic balance activities with or without head movements on firm floor or compliant surfaces. |
| Usual care physical therapy plus SEMD | Experimental | Device: Usual care physical therapy plus SEMDSubjects will receive usual care physical therapy intervention provided by vestibular balance specialists while using the Sensory Enrichment Multimodal Device (SEMD). SEMD protocols use visual, vibrotactile, and auditory cueing referenced to subject's Center of Gravity (COG) and/or Sum of Pressure (SOP) data collected from a force platform upon which the subject is placed. Static and dynamic balance activities with or without head movement are preformed while watching a computer screen; paced with an auditory metronome; and cued by "touch" vibration via coin tactors imbedded in a belt worn around the waist matching the COG/SOP data display. |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reporting 2 or more falls with or without injury within the past 6 months.
- Below normal SOT containing a abnormal vestibular score.
- Potential to benefit from physical therapy as indicated by physician prescription referral.
- Able to sit and to stand unaided for 2 minutes.
- Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Key exclusion criteria (6 listed)
- Fluctuating Meniere's
- Vestibular injury requiring surgery such as perilymph fistula
- Moderate progressive neurologic disease such as multiple sclerosis
- Does not speak and understand the English language
- Resides in a nursing home
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 |
|---|---|---|
| Usual care physical therapy plus SEMDAlso: BalanceSensePatients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects. | Device | Usual care physical therapy plus SEMD |
| Usual care physical therapy onlySubjects will receive usual care physical therapy from vestibular and balance specialists. | Other | Usual care physical therapy only |
Primary outcome
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).
Time frame: Pre Test to Post Test 1 after two physical therapy sessions (one week)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).
Time frame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).
Time frame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).
Time frame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
5 secondary outcomes
Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2
Time frame: Pre Test to Post Test 2 after four physical therapy sessions within 10 days
Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1
Time frame: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days
Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2
Time frame: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.
Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4
Time frame: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days
Head Shake Sensory Organization Test (HS_SOT)
Time frame: Pre Test, Post Test 1 and Post Test 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen L Atkins, PhD, PT study director
BalanceSense LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vestibular Diseases and Labyrinth Diseases, run by Karen L Atkins at 4 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 27 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT). (time frame: Pre Test to Post Test 1 after two physical therapy sessions (one week)). The study lists 4 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 27 Jun 2014.