Multiple SclerosisNCT01698086
Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)
A study testing Vestibular rehabilitation: balance and eye movement exercises in people with Multiple Sclerosis and Balance, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Impaired standing balance, fatigue and abnormal eye movements are common problems in persons with MS. These complaints are related to advanced disability and decreased quality of life for persons with MS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Balance, Fatigue
- What is being tested?
- Vestibular rehabilitation: balance and eye movement exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinically definite MS confirmed by a neurologist
- walk 100 meters with no greater than intermittent or unilateral constant assistive device support (coinciding with a Kurtzke Expanded Disability Status Scale (EDSS) range of 1.0 to 6.0: 1.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive)
- 18 to 60 years of age
- able to speak, read and understand English
- provide informed consent
- report at least a moderate level of fatigue (MFIS total score > 22)
- at least moderate level of impaired balance (SOT composite score < 82)
- minimal leg spasticity: score of <1 for the legs on the Modified Ashworth spasticity scale (score range: 0 - 4; 0 indicates no spasticity present, 4 is legs are rigid in all directions; 1 = indicates slight increased muscle tone)
Who cannot join
- non-ambulatory
- use of unilateral or bilateral foot, ankle and/or knee orthoses.
- medical history of other possible causes of fatigue (e.g. major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer)
- complete or legal blindness in one or both eyes.
- neurological disorder which might contribute to significant balance problems, such as cerebral vascular accident, peripheral neuropathy (including diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)
- documented MS-related exacerbation in the last three months.
- medical diagnosis or condition (e.g. cardiac, pulmonary, hepatic) that is considered to be an absolute or relative contraindication to participating in exercise
- participation in an exercise routine specifically designed to improve balance, fatigue and/or visual stability within 12 weeks prior to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus/University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?
Impaired standing balance, fatigue and abnormal eye movements are common problems in persons with MS. These complaints are related to advanced disability and decreased quality of life for persons with MS. Researchers from the University of Colorado and the Rocky Mountain Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and published a research study that showed an exercise program consisting of balance and eye movement training, referred to as a vestibular rehabilitation program, was very effective in improving self-reported fatigue and standing balance in persons with MS. This initial study was the first to have proven that this type of exercise program is able to improve both of these potentially devastating complaints.
The investigators from this initial study have partnered with other well-established researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of the effect of vestibular rehabilitation for persons with MS. Using the findings from the initial study, the investigators propose to conduct a larger study specifically identifying persons with MS who have brain lesion involvement in areas that control balance and eye movements. Primarily, the current study will determine if those individuals who have involvement in these areas of the brain improve more in balance and fatigue compared to those who do not following participation in a vestibular rehabilitation program. Additionally, the investigators will test if study participants who have abnormal eye movement control, will improve their eye movement control following the training program. For persons with MS, impaired eye movements can lead to a considerable decline in health status, further illustrating the importance of the research plan to study this important factor.
The investigators believe that greater improvements in balance and fatigue are possible from a longer treatment, and that participants who have brain lesion involvement in areas that help control balance and eye movements will benefit greater than those who do not. This information is important to determine who is more likely to benefit from a vestibular rehabilitation program. Additionally, the researchers will be able to measure changes in eye movement control, providing valuable insight into the reasons for the program's effectiveness.
Read the detailed description
Hypotheses and Specific Aims
Specific Aims Impaired balance (upright postural control), visual instability and fatigue are common complaints in persons with multiple sclerosis (MS), often leading to advanced disability and lower quality of life. MS affects structures throughout the central nervous system (CNS), with frequent involvement of infratentorial structures including the brainstem and cerebellum.1-4 These structures play integral roles in the process of maintaining balance.5-8 Indeed, for the person with MS, involvement of these structures is strongly linked to impaired balance, often leading to falls.9,10 To our knowledge, no studies have established effective treatment to improve balance specifically for persons with MS who have involvement of brainstem/cerebellar structures.
Our previous study11 provides evidence that vestibular rehabilitation, an exercise program involving balance and eye movement training, greatly improves balance and fatigue in patients with MS who have primary complaints in these areas. Brainstem and cerebellar dysfunctions are strongly associated with impaired balance.9,10 Analysis from our previous study indicates that greater improvements in balance from vestibular rehabilitation are likely for persons with MS who have brainstem and/or cerebellar involvement. Neural plasticity has been reported in persons with MS following task-specific training.12-15 We conceptualize that vestibular rehabilitation targets the CNS, specifically the brainstem and cerebellum, by providing the necessary task-specific stimuli for effective neural reorganization, improving central sensory integration resulting in improved balance and visual stability. Functioning with impaired balance and visual stability can be highly fatiguing. As such, we anticipate that this intervention approach also improves fatigue.
We propose a 16-wk, two-group, stratified-blocked randomized controlled trial. Our primary aim is to determine if vestibular rehabilitation for persons with MS is more effective in improving balance for those who have brainstem and/or cerebellar involvement compared to persons with MS who do not. In addition, because eye movement exercises are an important part of the proposed vestibular rehabilitation program, we will determine if significant changes in visual stability for persons with MS who present with abnormal eye movements are possible following participation in this program. Lastly, we will expand our knowledge of the benefits of vestibular rehabilitation on fatigue
Primary Aim: To compare changes in balance based on two strata: participants with brainstem and/or cerebellar involvement and those without, and to compare changes between the two study groups: Experimental group (vestibular rehabilitation program) and Wait-listed Control group (wait-listed for vestibular rehabilitation instruction).
Hypothesis (H1): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in balance compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in balance compared to the Wait-listed Control group.
Secondary Aim 1: To identify changes in eye movement dysfunction for participants in the Experimental group having eye movement dysfunction at baseline, and to compare changes between the two study groups.
Hypothesis (H2): 1) Participants in the Experimental group who present with impaired eye movements at baseline will improve significantly in visual stability following performance in the vestibular rehabilitation program compared to baseline values; 2) Participants in the Experimental group who present with impaired eye movements will improve significantly in visual stability compared to participants in the Wait-listed Control group who also present with impaired eye movements.
Secondary Aim 2: To compare changes in self-reported fatigue based on brainstem and/or cerebellar involvement stratum and between the two study groups.
Hypothesis (H3): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in fatigue compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in fatigue compared to the Wait-listed Control group.
An overarching objective of our research is to set the stage for future investigations of the underlying mechanisms responsible for the benefits found from vestibular rehabilitation. CNS involvement and neural plasticity will serve as primary targets of future investigations.
- Conditions
- Multiple Sclerosis, Balance, Fatigue, Eye Movement
- Being tested
- Vestibular rehabilitation: balance and eye movement exercises
- Keywords
- Multiple Sclerosis, Balance, Fatigue, Eye movement
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitation: balance and eye movement exercisesOther
The Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions. The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. The balance training includes standing and walking tasks on varied types of compliant surfaces, base of support, head movements, visual input and eye-hand tasks. The tasks will progress from simple to more complex. Eye movement exercises will include voluntary saccadic eye movements and smooth pursuit movements. Vestibulo-ocular eye training will be performed while visually fixating on a stationary object, while moving the head up and down and side to side at various speeds, progressing from sitting to standing on firm and compliant surface. Participants in the Experimental group will be given items of the exercise program to perform as a home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants who are randomized to the Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions (Figure 1). The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. Receives: Other: Vestibular rehabilitation: balance and eye movement exercises |
| Wait-listed Control group | No intervention | The Wait-listed Control group will not receive treatment; however, participants in the Wait-listed Control group will undergo the same outcome measurement plan as the Experimental group. If interested, participants from this group will be placed on a wait-list and will have the opportunity to receive instructions in how to perform the vestibular rehabilitation program following their completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance (Dynamic Posturography/Computerized Sensory Organization Test)
Change in balance from Baseline to 6 weeks and 14 weeks
Measured: 6 weeks and 14 weeks
Secondary outcomes (2)
Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test)
Change from Baseline in Visual Stability at 6 weeks 14 weeks
Measured: 6 weeks and 14 weeks
Perceived fatigue (Modified Fatigue Impact Scale)
Change from Baseline in Perceived fatigue at 6 weeks 14 weeks.
Measured: 6 weeks and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Hebert, PhD, PT, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698086
- Sponsor's protocol ID
- 12-1114
- Other IDs
- RG 4710A1/1
- Status last verified
- Jan 2019
- First submitted
- 25 Sep 2012
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebert JR, Corboy JR, Vollmer T, Forster JE, Schenkman M. Efficacy of Balance and Eye-Movement Exercises for Persons With Multiple Sclerosis (BEEMS). Neurology. 2018 Feb 27;90(9):e797-e807. doi: 10.1212/WNL.0000000000005013. Epub 2018 Jan 31.
PubMed 29386274
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?
- ClinicalTrials.gov ID
- NCT01698086
- Acronym / sponsor ID
- 12-1114
- Conditions
- Multiple Sclerosis, Balance, Fatigue, Eye Movement
- Keywords
- Multiple Sclerosis, Balance, Fatigue, Eye movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Oct 2012
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Oct 2012 (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.
Impaired standing balance, fatigue and abnormal eye movements are common problems in persons with MS. These complaints are related to advanced disability and decreased quality of life for persons with MS. Researchers from the University of Colorado and the Rocky Mountain Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and published a research study that showed an exercise program consisting of balance and eye movement training, referred to as a vestibular rehabilitation program, was very effective in improving self-reported fatigue and standing balance in persons with MS. This initial study was the first to have proven that this type of exercise program is able to improve both of these potentially devastating complaints.
The investigators from this initial study have partnered with other well-established researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of the effect of vestibular rehabilitation for persons with MS. Using the findings from the initial study, the investigators propose to conduct a larger study specifically identifying persons with MS who have brain lesion involvement in areas that control balance and eye movements. Primarily, the current study will determine if those individuals who have involvement in these areas of the brain improve more in balance and fatigue compared to those who do not following participation in a vestibular rehabilitation program. Additionally, the investigators will test if study participants who have abnormal eye movement control, will improve their eye movement control following the training program. For persons with MS, impaired eye movements can lead to a considerable decline in health status, further illustrating the importance of the research plan to study this important factor.
The investigators believe that greater improvements in balance and fatigue are possible from a longer treatment, and that participants who have brain lesion involvement in areas that help control balance and eye movements will benefit greater than those who do not. This information is important to determine who is more likely to benefit from a vestibular rehabilitation program. Additionally, the researchers will be able to measure changes in eye movement control, providing valuable insight into the reasons for the program's effectiveness.
Detailed description
Hypotheses and Specific Aims
Specific Aims Impaired balance (upright postural control), visual instability and fatigue are common complaints in persons with multiple sclerosis (MS), often leading to advanced disability and lower quality of life. MS affects structures throughout the central nervous system (CNS), with frequent involvement of infratentorial structures including the brainstem and cerebellum.1-4 These structures play integral roles in the process of maintaining balance.5-8 Indeed, for the person with MS, involvement of these structures is strongly linked to impaired balance, often leading to falls.9,10 To our knowledge, no studies have established effective treatment to improve balance specifically for persons with MS who have involvement of brainstem/cerebellar structures.
Our previous study11 provides evidence that vestibular rehabilitation, an exercise program involving balance and eye movement training, greatly improves balance and fatigue in patients with MS who have primary complaints in these areas. Brainstem and cerebellar dysfunctions are strongly associated with impaired balance.9,10 Analysis from our previous study indicates that greater improvements in balance from vestibular rehabilitation are likely for persons with MS who have brainstem and/or cerebellar involvement. Neural plasticity has been reported in persons with MS following task-specific training.12-15 We conceptualize that vestibular rehabilitation targets the CNS, specifically the brainstem and cerebellum, by providing the necessary task-specific stimuli for effective neural reorganization, improving central sensory integration resulting in improved balance and visual stability. Functioning with impaired balance and visual stability can be highly fatiguing. As such, we anticipate that this intervention approach also improves fatigue.
We propose a 16-wk, two-group, stratified-blocked randomized controlled trial. Our primary aim is to determine if vestibular rehabilitation for persons with MS is more effective in improving balance for those who have brainstem and/or cerebellar involvement compared to persons with MS who do not. In addition, because eye movement exercises are an important part of the proposed vestibular rehabilitation program, we will determine if significant changes in visual stability for persons with MS who present with abnormal eye movements are possible following participation in this program. Lastly, we will expand our knowledge of the benefits of vestibular rehabilitation on fatigue
Primary Aim: To compare changes in balance based on two strata: participants with brainstem and/or cerebellar involvement and those without, and to compare changes between the two study groups: Experimental group (vestibular rehabilitation program) and Wait-listed Control group (wait-listed for vestibular rehabilitation instruction).
Hypothesis (H1): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in balance compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in balance compared to the Wait-listed Control group.
Secondary Aim 1: To identify changes in eye movement dysfunction for participants in the Experimental group having eye movement dysfunction at baseline, and to compare changes between the two study groups.
Hypothesis (H2): 1) Participants in the Experimental group who present with impaired eye movements at baseline will improve significantly in visual stability following performance in the vestibular rehabilitation program compared to baseline values; 2) Participants in the Experimental group who present with impaired eye movements will improve significantly in visual stability compared to participants in the Wait-listed Control group who also present with impaired eye movements.
Secondary Aim 2: To compare changes in self-reported fatigue based on brainstem and/or cerebellar involvement stratum and between the two study groups.
Hypothesis (H3): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in fatigue compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in fatigue compared to the Wait-listed Control group.
An overarching objective of our research is to set the stage for future investigations of the underlying mechanisms responsible for the benefits found from vestibular rehabilitation. CNS involvement and neural plasticity will serve as primary targets of future investigations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Vestibular rehabilitation: balance and eye movement exercisesParticipants who are randomized to the Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions (Figure 1). The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. |
| Wait-listed Control group | No intervention | –The Wait-listed Control group will not receive treatment; however, participants in the Wait-listed Control group will undergo the same outcome measurement plan as the Experimental group. If interested, participants from this group will be placed on a wait-list and will have the opportunity to receive instructions in how to perform the vestibular rehabilitation program following their completion of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- clinically definite MS confirmed by a neurologist
- walk 100 meters with no greater than intermittent or unilateral constant assistive device support (coinciding with a Kurtzke Expanded Disability Status Scale (EDSS) range of 1.0 to 6.0: 1.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive)
- 18 to 60 years of age
- able to speak, read and understand English
- provide informed consent
Key exclusion criteria (8 listed)
- non-ambulatory
- use of unilateral or bilateral foot, ankle and/or knee orthoses.
- medical history of other possible causes of fatigue (e.g. major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer)
- complete or legal blindness in one or both eyes.
- neurological disorder which might contribute to significant balance problems, such as cerebral vascular accident, peripheral neuropathy (including diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)
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 |
|---|---|---|
| Vestibular rehabilitation: balance and eye movement exercisesThe Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions. The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. The balance training includes standing and walking tasks on varied types of compliant surfaces, base of support, head movements, visual input and eye-hand tasks. The tasks will progress from simple to more complex. Eye movement exercises will include voluntary saccadic eye movements and smooth pursuit movements. Vestibulo-ocular eye training will be performed while visually fixating on a stationary object, while moving the head up and down and side to side at various speeds, progressing from sitting to standing on firm and compliant surface. Participants in the Experimental group will be given items of the exercise program to perform as a home exercise program. | Other | Experimental group |
Primary outcome
Balance (Dynamic Posturography/Computerized Sensory Organization Test)
Time frame: 6 weeks and 14 weeks
Change in balance from Baseline to 6 weeks and 14 weeks
2 secondary outcomes
Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test)
Time frame: 6 weeks and 14 weeks
Perceived fatigue (Modified Fatigue Impact Scale)
Time frame: 6 weeks and 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 29386274Hebert JR, Corboy JR, Vollmer T, Forster JE, Schenkman M. Efficacy of Balance and Eye-Movement Exercises for Persons With Multiple Sclerosis (BEEMS). Neurology. 2018 Feb 27;90(9):e797-e807. doi: 10.1212/WNL.0000000000005013. Epub 2018 Jan 31.
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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.
Jeffrey R Hebert, PhD, PT principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation: balance and eye movement exercises in people with Multiple Sclerosis and Balance, run by University of Colorado, Denver 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 8 inclusion and 8 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 29 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Balance (Dynamic Posturography/Computerized Sensory Organization Test) (time frame: 6 weeks and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698086, which also lists 1 linked publication.
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 29 Jan 2019.