Spinal InstabilityNCT02435485
The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
A study testing Biodex balance training and Rehabilitation including core spinal stabilization exercise in people with Spinal Instability, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Instability
- What is being tested?
- Biodex balance training and Rehabilitation including core spinal stabilization exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, low back pain, or radicular symptoms and diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis as the experimental group and thirty-five patients with lumbar spondylitis will be included as the control group.
Who cannot join
- Patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment. -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Kaohsiung City, 83305
Mei-Yun Liaw, MD, 886-7-7317123 ext. 6286, meiyunliaw@cgmh.org.tw
Ling-Yi Wang, MD, 886-7-7317123 ext. 6286, s801121@cloud.cgmh.org.tw
About this study
Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. There are very few research on the effectiveness of core spine stabilization exercise, balance training, and the balance effect while wearing lumbar corset in these patients.
Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance training and balance effect of the wearing of lumbar corset in patients with degenerative lumbar spondylolisthesis .
Read the detailed description
Subjects :Seventy patients with lumbar spondylolisthesis will be randomly assigned to the group treated with balance training and without balance training, and another thirty-five age-matched lumbar spondylitis without spondylolisthesis will be assigned as control group.
Method: Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis will be recruited as experimental group and thirty-five patients with lumbar spondylitis will be recruited as control group. Exclusion criteria are patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment.
All subjects will receive Visual Analogue Scale (VAS), Oswestry Disability Index, Quebec back pain disability scale, and the postural stability test, 75% limits of stability test, modified clinical test of sensory integration, and the evaluation of fall risk test of Biodex balance system at beginning and at the end of program. Both the control and experimental groups will receive rehabilitation training, including hot packing, interferential therapy, core spine stabilization exercise and lower extremity strengthening exercise for 2-3 times a week, up to 8 weeks, 15 sessions in total. Patients in the experimental group will be randomly assigned to either a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program. The investigators will follow up with these patients by telephone 3 months after program completion.
The clinical history, age, gender, body weight, body height, job, symptoms and sign, Visual Analogue Scalce (VAS), Questionnairem (Quebec back pain disability scale) and Oswestry Disability Index will be recorded at base and after rehabilitation program. Every subject will sign the informed consent, which will be obtained from the Institutional Review Board of Chang Gung Memorial Hospital.
Physical examination It will include the duration, pain intensity, neurologic deficits, muscle power of lower limbs, deep tendon reflex, sensation, stretch sign or nerve conduction velocity, or electromyography examination.
Radiography All subjects will receive Kidney Ureter Bladder (KUB) and standing lateral radiography of lumbar-sacral spine in neutral, to determine the pelvic incidence, pelvic tilt, sacral slope etc. Furthermore the patients with spondylolisthesis will receive flexion-extension of lumbar-sacral spine to determine the degree of translational motion of vertebrae.
Rehabilitation Correct body posture and lifting techniques will be instructed. After patient's back pain subside to a degree of less than 5 of visual analogue scale (VAS), balance test will be assessed by using the Biodex Balance System (BBS), including postual stability test, limits of stability test, modified clinical test of sensory intergration and fall risk test. The spondylolisthesis patients will be assessed while wearing or without wearing lumbar corset at the beginning of the program, which will be tested in a random order. The tester for BBS will be blind to the patient's grouping. The anterio-posterior, medial-lateral stability index and overall stability index etc will be recorded.
Both groups will receive 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include 15-minute hot packing, 15-minutes interferential therapy, about 25 minutes of core spine stablilzation exercise and low extremity strengthening exercise on the stationary bicycle. And patients in the experimental group will be randomly assigned either to a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program.
Balance test
- Postual stability test: Patients will stand barefoot on the platform with a slight knee flexion, look straight ahead with arms across the chest on the platform, and then subject will be asked to maintain a quiet stance on the platform for seconds for initialization. Six stability trials will be performed with eyes open and eyes closed over a period of 20 seconds, 3 trials per each state, with 10-second count rest countdown in between the trials.
- Limits of stabitiy (LOS) test (75% LOS): an indicator of dynamic control within a normalized envelope. Nine targets blink in random order on the screen. Patient have to shift body weight to move the cursor frorm the center target to a blinking target and back as quickly and with as little deviation as possible. The overall direction control of overall, forward, backward, right, left, forward/right, forward/right, backward/right and backward/left will be recorded.
- Modified clinical test of sensory intergration: It consists of the first condition: eye open with firm surface, the second condition: eye closed with firm surface, the third condition: eye open with foam surface and the fourth condition: eye closed with foam surface
- Fall risk test: to identify the high potential fall risk patient.
Rehabilitation program (Home base or outpatient training) Education: Both of home base and outpatient training patients will be instructed to use superficial heat for relief of back pain, muscle spasm; and correct posture of the activities of daily living (sitting, standing, sleeping, working and driving), lifting techniques, avoidance of certain movements and postures, such as prolonged standing or sitting, slouched in a soft armchair, sagging bed mattresses, wearing high heels or carrying heavy objects. And lumbar corset for stabilization of spine will be recommended.
Outpatient program: Two to three times a week, 15 treatment sessions, about 60 minutes per session, up to 8 weeks. It will include hot pack and/or interferential therapy about 15 minutes. Exercise (about 25 min) will begin with a short warm-up aerobic exercise, upper back and shoulder extension exercise, pectoral stretching exercise, back extension exercise, combined with deep-breathing exercise; then a core strengthening program, including cat and camel, abdominal hollowing, bridge, dead bug, quadruped etc. The exercise will be 3 sessions of 10-15 repetitions.
Balance training Balance training: same as rehabilitation program (total 15 sessions, 2-3 times a weeks)
- Weight shifting training Guiding moving point (a) from quarter one to quarter three, (b) from quarter two to quarter four, (c) in parallel to the vertical line in the feedback screen (anterior-posterior direction)
- Random training It is ideal for motor control and vestibular training. Static mode : work within the sway envelope to move the cursor and attempt to keep it within the moving target.
Dynamic mode: use hip, knee and ankle strategies to manipulate the moving palteform's cursor to within the random moving target.
- Conditions
- Spinal Instability
- Being tested
- Biodex balance training, Rehabilitation including core spinal stabilization exercise
- Keywords
- degerative lumbar spondylolisthesis, rehabilitation, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex balance trainingDevice
1.weight shift training, 2. random control training with Biodex balance system.
Rehabilitation including core spinal stabilization exerciseOther
Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.
| Study group | Role | What they receive |
|---|---|---|
| spondylolisthesis with balance training | Experimental | Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise. Receives: Device: Biodex balance training; Other: Rehabilitation including core spinal stabilization exercise |
| spondylolisthesis, no balance training | Active comparator | Intervention: Regular rehabilitation including core spinal stabilization exercise Receives: Other: Rehabilitation including core spinal stabilization exercise |
| lumbar spondylitis | Active comparator | Intervention: Regular rehabilitation including core spinal stabilization exercise Receives: Other: Rehabilitation including core spinal stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance test
- Postural stability test: overall index___, anterior-posterior index___, medial-lateral index____
- Limits of stability test: forward___, backward___, right___, left___, forward/right___, forward/left___, backward/right___, backward/left___
- Modified clinical test of sensory integration: sway index: eye open, firm___; eye close,firm___, eye open, foam___, eye close foam___
- Fall risk test: actual score, STD_______
Measured: 8 weeks, 6 months
Secondary outcomes (3)
Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire)
To measure a patient's permanent functional disability
Measured: 8 week, 6 months
Quebec back pain disability scale
This questionnaire is about the way patient's back pain affecting their daily life
Measured: 8 weeks, 6 months
Visual analog scale (VAS) of low back pain and radicular pain
Visual analog scale [VAS] is a measure of pain intensity
Measured: 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InstabilityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Yun Liaw, Chang Gung Memorial Hospital
- Investigators
- Mei-Yun Liaw, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435485
- Sponsor's protocol ID
- CMRPG8D0911
- Status last verified
- May 2018
- First submitted
- 27 Apr 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02435485
- Acronym / sponsor ID
- CMRPG8D0911
- Conditions
- Spinal Instability
- Keywords
- degerative lumbar spondylolisthesis, rehabilitation, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 6 May 2015 (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.
Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. There are very few research on the effectiveness of core spine stabilization exercise, balance training, and the balance effect while wearing lumbar corset in these patients.
Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance training and balance effect of the wearing of lumbar corset in patients with degenerative lumbar spondylolisthesis .
Detailed description
Subjects :Seventy patients with lumbar spondylolisthesis will be randomly assigned to the group treated with balance training and without balance training, and another thirty-five age-matched lumbar spondylitis without spondylolisthesis will be assigned as control group.
Method: Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis will be recruited as experimental group and thirty-five patients with lumbar spondylitis will be recruited as control group. Exclusion criteria are patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment.
All subjects will receive Visual Analogue Scale (VAS), Oswestry Disability Index, Quebec back pain disability scale, and the postural stability test, 75% limits of stability test, modified clinical test of sensory integration, and the evaluation of fall risk test of Biodex balance system at beginning and at the end of program. Both the control and experimental groups will receive rehabilitation training, including hot packing, interferential therapy, core spine stabilization exercise and lower extremity strengthening exercise for 2-3 times a week, up to 8 weeks, 15 sessions in total. Patients in the experimental group will be randomly assigned to either a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program. The investigators will follow up with these patients by telephone 3 months after program completion.
The clinical history, age, gender, body weight, body height, job, symptoms and sign, Visual Analogue Scalce (VAS), Questionnairem (Quebec back pain disability scale) and Oswestry Disability Index will be recorded at base and after rehabilitation program. Every subject will sign the informed consent, which will be obtained from the Institutional Review Board of Chang Gung Memorial Hospital.
Physical examination It will include the duration, pain intensity, neurologic deficits, muscle power of lower limbs, deep tendon reflex, sensation, stretch sign or nerve conduction velocity, or electromyography examination.
Radiography All subjects will receive Kidney Ureter Bladder (KUB) and standing lateral radiography of lumbar-sacral spine in neutral, to determine the pelvic incidence, pelvic tilt, sacral slope etc. Furthermore the patients with spondylolisthesis will receive flexion-extension of lumbar-sacral spine to determine the degree of translational motion of vertebrae.
Rehabilitation Correct body posture and lifting techniques will be instructed. After patient's back pain subside to a degree of less than 5 of visual analogue scale (VAS), balance test will be assessed by using the Biodex Balance System (BBS), including postual stability test, limits of stability test, modified clinical test of sensory intergration and fall risk test. The spondylolisthesis patients will be assessed while wearing or without wearing lumbar corset at the beginning of the program, which will be tested in a random order. The tester for BBS will be blind to the patient's grouping. The anterio-posterior, medial-lateral stability index and overall stability index etc will be recorded.
Both groups will receive 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include 15-minute hot packing, 15-minutes interferential therapy, about 25 minutes of core spine stablilzation exercise and low extremity strengthening exercise on the stationary bicycle. And patients in the experimental group will be randomly assigned either to a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program.
Balance test
- Postual stability test: Patients will stand barefoot on the platform with a slight knee flexion, look straight ahead with arms across the chest on the platform, and then subject will be asked to maintain a quiet stance on the platform for seconds for initialization. Six stability trials will be performed with eyes open and eyes closed over a period of 20 seconds, 3 trials per each state, with 10-second count rest countdown in between the trials.
- Limits of stabitiy (LOS) test (75% LOS): an indicator of dynamic control within a normalized envelope. Nine targets blink in random order on the screen. Patient have to shift body weight to move the cursor frorm the center target to a blinking target and back as quickly and with as little deviation as possible. The overall direction control of overall, forward, backward, right, left, forward/right, forward/right, backward/right and backward/left will be recorded.
- Modified clinical test of sensory intergration: It consists of the first condition: eye open with firm surface, the second condition: eye closed with firm surface, the third condition: eye open with foam surface and the fourth condition: eye closed with foam surface
- Fall risk test: to identify the high potential fall risk patient.
Rehabilitation program (Home base or outpatient training) Education: Both of home base and outpatient training patients will be instructed to use superficial heat for relief of back pain, muscle spasm; and correct posture of the activities of daily living (sitting, standing, sleeping, working and driving), lifting techniques, avoidance of certain movements and postures, such as prolonged standing or sitting, slouched in a soft armchair, sagging bed mattresses, wearing high heels or carrying heavy objects. And lumbar corset for stabilization of spine will be recommended.
Outpatient program: Two to three times a week, 15 treatment sessions, about 60 minutes per session, up to 8 weeks. It will include hot pack and/or interferential therapy about 15 minutes. Exercise (about 25 min) will begin with a short warm-up aerobic exercise, upper back and shoulder extension exercise, pectoral stretching exercise, back extension exercise, combined with deep-breathing exercise; then a core strengthening program, including cat and camel, abdominal hollowing, bridge, dead bug, quadruped etc. The exercise will be 3 sessions of 10-15 repetitions.
Balance training Balance training: same as rehabilitation program (total 15 sessions, 2-3 times a weeks)
- Weight shifting training Guiding moving point (a) from quarter one to quarter three, (b) from quarter two to quarter four, (c) in parallel to the vertical line in the feedback screen (anterior-posterior direction)
- Random training It is ideal for motor control and vestibular training. Static mode : work within the sway envelope to move the cursor and attempt to keep it within the moving target.
Dynamic mode: use hip, knee and ankle strategies to manipulate the moving palteform's cursor to within the random moving target.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spondylolisthesis with balance training | Experimental | Device: Biodex balance training, Other: Rehabilitation including core spinal stabilization exerciseIntervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise. |
| spondylolisthesis, no balance training | Active comparator | Other: Rehabilitation including core spinal stabilization exerciseIntervention: Regular rehabilitation including core spinal stabilization exercise |
| lumbar spondylitis | Active comparator | Other: Rehabilitation including core spinal stabilization exerciseIntervention: Regular rehabilitation including core spinal stabilization exercise |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, low back pain, or radicular symptoms and diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis as the experimental group and thirty-five patients with lumbar spondylitis will be included as the control group.
Key exclusion criteria (1 listed)
- Patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment. -
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 |
|---|---|---|
| Biodex balance training1.weight shift training, 2. random control training with Biodex balance system. | Device | spondylolisthesis with balance training |
| Rehabilitation including core spinal stabilization exerciseRehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise. | Other | lumbar spondylitis, spondylolisthesis with balance training, spondylolisthesis, no balance training |
Primary outcome
Biodex balance test
Time frame: 8 weeks, 6 months
1. Postural stability test: overall index___, anterior-posterior index___, medial-lateral index____ 2. Limits of stability test: forward___, backward___, right___, left___, forward/right___, forward/left___, backward/right___, backward/left___ 3. Modified clinical test of sensory integration: sway index: eye open, firm___; eye close,firm___, eye open, foam___, eye close foam___ 4. Fall risk test: actual score, STD_______
3 secondary outcomes
Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire)
Time frame: 8 week, 6 months
Quebec back pain disability scale
Time frame: 8 weeks, 6 months
Visual analog scale (VAS) of low back pain and radicular pain
Time frame: 8 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
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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.
Mei-Yun Liaw, MD principal investigator
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex balance training and Rehabilitation including core spinal stabilization exercise in people with Spinal Instability, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. 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 Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Yun Liaw, MD (886-7-7317123 ext. 6286, meiyunliaw@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance test (time frame: 8 weeks, 6 months). 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 22 May 2018.