Traumatic Brain InjuryNCT01672658
Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
A study testing Sensory Kinetics Balance System and Traditional Vestibular Rehabilitation in people with Traumatic Brain Injury and Vestibular Deficits, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, Vestibular Deficits
- What is being tested?
- Sensory Kinetics Balance System and Traditional Vestibular Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate Traumatic Brain Injury
- Adults 18 years-75 years old
- Vestibular \&/or balance deficit following mild/moderate TBI and confirmed by healthcare professional
- Subjects reporting head injury from exposure to a blast/concussion injury with one or more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia, movement induced vertigo.
- Able to sit unaided for two minutes
- Able to stand independently with or without a cane, or with no more than moderate assistance from the physical therapist/researcher.
Who cannot join
- Multiple trauma
- Severe brain injury as defined above
- Pacemakers
- Weight greater than 250 lbs
- Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than 25
- A diagnosis of:
Show all 11Show fewer
- Peripheral neuropathy
- Severe neuromuscular diseases
- Severe Cardiovascular disease
- Associated high-level stroke or spinal cord injury
- Amputees
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.
The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments.
This study is primarily funded through Engineering Acoustics as a subcontract for a phase II Small Business Innovation Research by the Department of Defense.
Read more
- Hypotheses \& Research Objectives and Purpose:
The specific research questions to be addressed are:
- How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT intervention on balance and functional gait measures in mild traumatic brain injury (mTBI) participants.
- How do SKBS measurement tools compare to standard clinical assessments of gait and balance in mTBI patients The purpose of this clinical research study is to compare the value and benefit of the SK multimodal balance training system in combination with traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in clinical measures of balance, functional mobility, and gait assessment.
Read the detailed description
Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue over time and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mild Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of the overall disability.
TBI is one of the many risks faced by military personnel in combat activities . In a RAND Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19% reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and debilitating component of the overall disability. mTBI are currently caused by both blast and impact injuries resulting in variable disabilities . Overt symptoms may include balance and spatial disorientation problems (vertigo) related to vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory integration deficits.
Treatment of this particular population group has several challenges which include: 1) difficulty with early and specific injury assessment 2) the determination of appropriate return-to-duty measures 3) selection of effective individualized balance rehabilitation and treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints. The group is also highly variable in the nature and extent of balance deficits and cognitive and / or related psychological impairments. It appears that almost all subjects with mTBI show some susceptibility to vestibular or vestibular/ocular disorders.
After assessment of disequilibrium, rehabilitation is often a course of remedial physical therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor systems are "habituated" through exercise, with hope of rehabilitating the system and "compensating" by instructing the patient to alter skill sets associated with a task. Compensation (without immediate sensory feedback) is problematic and prone to patient (and caregiver) interpretation and error, because it may not address the underlying problems and may not have long term therapeutic benefits. There is also a very limited pool of PTs who specialize in the treatment of neurological problems resulting from brain injuries. Individual vestibular rehabilitation treatment programs are designed by these specialist PTs who also monitor and participate in each patient's recovery. This approach is labor intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do not recover fully .
The overall objective of this research effort is to use novel combinations of multi-modal sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to retrain military personnel suffering balance disorders as a result of mTBI. The investigators therapeutic goal is to test technology that will return the patient, in the shortest period of time, to a level of balance performance consistent with return to the community and/or military duty.
The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex and higher cognitive regions, which makes it uniquely tied to orientation and localization. Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.
Recent research has also demonstrated that tactile cueing yield significantly faster and more accurate performance than comparable spatial auditory cues. Further research has demonstrated this finding is relatively stable across a variety of body orientations, even when spatial translation is required and under physiological stress.
Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform (see Figure 1) while movement and posture data is interpreted by advanced software a mapped to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides continuous and instantaneous feedback to the patient that compliments their postural and mobility decisions. The investigators believe that vibrotactile feedback can greatly increase spatial awareness and consequently mobility. Further, the ability of the brain to re-organize and relearn functional movement activities provides an intriguing potential pathway for the retention of learned functional mobility strategies.Vibrotactile cueing involves short duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a torso worn belt. The person's position is measured and calculated using a force plate sensor and camera sensors. The computerized system is then used as part of physical therapy balance training to improve the patient's balance and potentially reduce their risk of falling.
- Conditions
- Traumatic Brain Injury, Vestibular Deficits
- Being tested
- Sensory Kinetics Balance System, Traditional Vestibular Rehabilitation
- Keywords
- TBI,, vestibular
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Kinetics Balance SystemDevice
Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
Traditional Vestibular RehabilitationOther
Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Kinectics Balance System | Experimental | Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training. Receives: Device: Sensory Kinetics Balance System |
| Traditional Vestibular Rehabilitation | Active comparator | Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility. Receives: Other: Traditional Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.
Measured: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)
Functional Gait Assessment (FGA)
Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment
- = moderate impairment
- = mild impairment
- = normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device
Measured: Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)
Secondary outcomes (6)
10 Meter Walk Test
assesses walking speed of short duration
Measured: Pre-training, mid training (4 weeks), post training (8 weeks)
Six Minute Walk Test
Assesses distance walked over 6 minutes
Measured: Pre-training, mid training (4 weeks), post training (8 weeks)
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed
Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages
Measured: Pre-training, mid training, post training
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open
The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages
Measured: Pre-training, mid training (4 weeks), post training (8 weeks)
Activities Balance Confidence Scale (ABC)
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items
Measured: Pre-training, mid training, post training
Dizziness Handicap Inventory
A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)
Measured: Pre-training, mid training, post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionNov 2014
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 Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Edward Hines Jr. VA Hospital
- Responsible party
- Principal investigator, Arun Jayaraman, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672658
- Sponsor's protocol ID
- NUSTU58913
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2012
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.
- ClinicalTrials.gov ID
- NCT01672658
- Acronym / sponsor ID
- NUSTU58913
- Conditions
- Traumatic Brain Injury, Vestibular Deficits
- Keywords
- TBI,, vestibular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- United States Department of Defense, Edward Hines Jr. VA Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments.
This study is primarily funded through Engineering Acoustics as a subcontract for a phase II Small Business Innovation Research by the Department of Defense.
- Hypotheses \& Research Objectives and Purpose:
The specific research questions to be addressed are:
- How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT intervention on balance and functional gait measures in mild traumatic brain injury (mTBI) participants.
- How do SKBS measurement tools compare to standard clinical assessments of gait and balance in mTBI patients The purpose of this clinical research study is to compare the value and benefit of the SK multimodal balance training system in combination with traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in clinical measures of balance, functional mobility, and gait assessment.
Detailed description
Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue over time and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mild Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of the overall disability.
TBI is one of the many risks faced by military personnel in combat activities . In a RAND Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19% reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and debilitating component of the overall disability. mTBI are currently caused by both blast and impact injuries resulting in variable disabilities . Overt symptoms may include balance and spatial disorientation problems (vertigo) related to vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory integration deficits.
Treatment of this particular population group has several challenges which include: 1) difficulty with early and specific injury assessment 2) the determination of appropriate return-to-duty measures 3) selection of effective individualized balance rehabilitation and treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints. The group is also highly variable in the nature and extent of balance deficits and cognitive and / or related psychological impairments. It appears that almost all subjects with mTBI show some susceptibility to vestibular or vestibular/ocular disorders.
After assessment of disequilibrium, rehabilitation is often a course of remedial physical therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor systems are "habituated" through exercise, with hope of rehabilitating the system and "compensating" by instructing the patient to alter skill sets associated with a task. Compensation (without immediate sensory feedback) is problematic and prone to patient (and caregiver) interpretation and error, because it may not address the underlying problems and may not have long term therapeutic benefits. There is also a very limited pool of PTs who specialize in the treatment of neurological problems resulting from brain injuries. Individual vestibular rehabilitation treatment programs are designed by these specialist PTs who also monitor and participate in each patient's recovery. This approach is labor intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do not recover fully .
The overall objective of this research effort is to use novel combinations of multi-modal sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to retrain military personnel suffering balance disorders as a result of mTBI. The investigators therapeutic goal is to test technology that will return the patient, in the shortest period of time, to a level of balance performance consistent with return to the community and/or military duty.
The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex and higher cognitive regions, which makes it uniquely tied to orientation and localization. Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.
Recent research has also demonstrated that tactile cueing yield significantly faster and more accurate performance than comparable spatial auditory cues. Further research has demonstrated this finding is relatively stable across a variety of body orientations, even when spatial translation is required and under physiological stress.
Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform (see Figure 1) while movement and posture data is interpreted by advanced software a mapped to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides continuous and instantaneous feedback to the patient that compliments their postural and mobility decisions. The investigators believe that vibrotactile feedback can greatly increase spatial awareness and consequently mobility. Further, the ability of the brain to re-organize and relearn functional movement activities provides an intriguing potential pathway for the retention of learned functional mobility strategies.Vibrotactile cueing involves short duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a torso worn belt. The person's position is measured and calculated using a force plate sensor and camera sensors. The computerized system is then used as part of physical therapy balance training to improve the patient's balance and potentially reduce their risk of falling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Kinectics Balance System | Experimental | Device: Sensory Kinetics Balance SystemSubjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training. |
| Traditional Vestibular Rehabilitation | Active comparator | Other: Traditional Vestibular RehabilitationTraditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild to moderate Traumatic Brain Injury
- Adults 18 years-75 years old
- Vestibular \&/or balance deficit following mild/moderate TBI and confirmed by healthcare professional
- Subjects reporting head injury from exposure to a blast/concussion injury with one or more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia, movement induced vertigo.
- Able to sit unaided for two minutes
Key exclusion criteria (11 listed)
- Multiple trauma
- Severe brain injury as defined above
- Pacemakers
- Weight greater than 250 lbs
- Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than 25
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 |
|---|---|---|
| Sensory Kinetics Balance SystemSubjects will participate in balance/gait/functional mobility training twice a week for 8 weeks. | Device | Sensory Kinectics Balance System |
| Traditional Vestibular RehabilitationSubjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility. | Other | Traditional Vestibular Rehabilitation |
Primary outcome
Berg Balance Scale
Time frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)
The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.
Functional Gait Assessment (FGA)
Time frame: Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)
Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect. 10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment 1. = moderate impairment 2. = mild impairment 3. = normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device
6 secondary outcomes
10 Meter Walk Test
Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
Six Minute Walk Test
Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed
Time frame: Pre-training, mid training, post training
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open
Time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
Activities Balance Confidence Scale (ABC)
Time frame: Pre-training, mid training, post training
Dizziness Handicap Inventory
Time frame: Pre-training, mid training, post training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- 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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Kinetics Balance System and Traditional Vestibular Rehabilitation in people with Traumatic Brain Injury and Vestibular Deficits, run by Shirley Ryan AbilityLab 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 6 inclusion and 11 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 4 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2016). 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?
Berg Balance Scale (time frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 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 4 Apr 2016.