Brain Injuries, TraumaticNCT03110237
A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI
A study testing Fallproof Balance Training (BT) class in people with Brain Injuries, Traumatic and Cerebrovascular Trauma, run by University of British Columbia at 1 site in Canada.
Trial summary
Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased risks of falls. Previous studies indicate that balance training improves balance, reduces falls, and increases walking speed and balance confidence. Read more about this study
- Who is it for?
- Ages 16 to 69 years
- Conditions the study is for
- Brain Injuries, Traumatic, Cerebrovascular Trauma, Acute Brain Injuries
- What is being tested?
- Fallproof Balance Training (BT) class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 10 Apr 2017to 30 Dec 2017
- 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 16 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- inpatients admitted to GFS with a diagnosis of ABI;
- medical stability
- has the cognitive ability to understand and follow instructions and participate in a class setting
- a Berg Balance Score of ≥52;
- able to walk independently with or without a mobility aid.
Who cannot join
- 1) unable to attend class in a group setting and/or unable to follow instructions.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Center
Vancouver, British Columbia, V5Z 2G9
Sophia Si Cong Zhao, MPT, 604-734-1313 ext. 2549, sophia.zhao@vch.ca
About this study
Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased risks of falls. Previous studies indicate that balance training improves balance, reduces falls, and increases walking speed and balance confidence. The purpose of this study is to determine if a multidimensional balance training based on the FallProof(TM) approach achieves better improvements in balance and walking performance than the current practice . Participants will be assigned to: 1)a task-oriented circuit training balance class (current practice), or 2) balance training class based on the FallProof(TM) approach. Standardized tests will determine if participating in balance training helps improve balance, walking speed and balance confidence.
Read the detailed description
The purpose of this pilot research study is to determine if a balance training (BT) class based on the FallProof(TM) approach achieves better balance and mobility outcomes than the current practice. The FallProof's approach focuses on multiple components of balance impairment including multisensory, postural strategy and centre of gravity control training. Current practice is a task-oriented circuit training balance class.
ABI survivors may have muscle weakness, decreased coordination and sensory loss, which contribute to reduced balance, difficulty with functional mobility and activities of daily living. Balance control provides the foundation for a person's ability to stand, walk and function independently. Previous studies indicate that balance training (BT) improves balance, reduces falls, increases walking speed and balance self-efficacy for ABI patients .The Ottawa Panel Evidence-Based Clinical Practice Guidelines for ABI Rehabilitation supported the use of BT based on the research evidence. Interventions such as task-oriented training, multisensory training, trunk control training and perceptual exercises demonstrate positive effect on balance and mobility outcomes. To our knowledge, there are few studies that have examined a multidimensional approach to BT.
A systematic review concluded that exercises performed for 20-60 minutes, 3-4 times a week for 6-12 weeks can improve balance in ABI patients. However, Treacy et al demonstrated that inpatient BT for just 2 weeks can improve balance compared to a control group who received traditional exercise interventions.
At GF Strong Rehabilitation Center (GFS), the usual care provided to the ambulatory ABI patients consists of individualized one to one physiotherapy treatment, as well as a high level BT class. Currently, this BT class is a circuit training class that focuses on task-oriented gait exercises. FallProof balance training is a group- based approach that includes multisensory, postural strategy, centre of gravity control and gait pattern training. It was originally developed for older adults with impaired balance; but there is no research on the effectiveness of this approach for ABI patients. The FallProof approach has been introduced to the low level and intermediate level BT class at GFS, for ABI patients with sever and moderate balance impairments. These classes received positive feedback from patients and therapists. Patients reported improved functional mobility and confidence after attending the class. However, there was no functional outcome measurements collected to compare the effectiveness of the previous class and the new FallProof class. We plan to modify the current circuit training high level balance class with the FallProof approach in the spring of 2017. Before introducing the FallProof class, we would like to collect outcome measures with the current BT class for three months, and then collect collect data with the new class for comparison. We would like to determine if a multidimensional group based BT treatment approach is more effective at improving functional outcomes compared to the current practice.
- Being tested
- Control Balance Training (BT) class, Fallproof Balance Training (BT) class
- Medical subject headings
- Brain Injuries, Traumatic, Cerebrovascular Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Balance Training (BT) classOther
Circuit training class with 11 stations, including: step-ups, ball kicking, balance beam, sit to stand, walk and carry, tandem walking, walking over a mat, walking up a ramp, walking at different speeds, speed walk, dual task walking.
Fallproof Balance Training (BT) classOther
There are four categories of exercises in this approach including: center of gravity control training (e.g. multi-directional weight shifts in standing, standing with altered base of support), multisensory training (e.g. standing on compliant surfaces, eyes open/closed), postural strategy training (e.g. resisted perturbation to facilitate ankle, hip or step strategy), and gait pattern variation training (e.g. walking with altered base of support , walking over and around obstacles). Each training category will be allocated 5 minutes with two exercises in each category. An additional 5 minutes will be allotted for games to challenge balance (balloon volleyball, pass the potato, circle soccer).There will be opportunity for group discussion and observational learning.
| Study group | Role | What they receive |
|---|---|---|
| Control Balance Training (BT) class | Active comparator | Group based circuit training class, 30 minute session, twice a week for three weeks Receives: Other: Control Balance Training (BT) class |
| Fallproof Balance Training (BT) class | Experimental | Group based balance training class based on the FallProof(TM) approach, 30 minute session , twice a week for three weeks Receives: Other: Fallproof Balance Training (BT) class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Balance and Mobility Scale (CB & M)
A performance measure composed of 13 challenging tasks. Item scores range from 0 to 5 and reflect progressive task difficulty. All tasks performed without ambulation aides.
Measured: after attending balance class for 3 weeks
Secondary outcomes (3)
Timed Up and Go Test (TUG)
Timing how long it takes for patient to rise from a chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.
Measured: after attending balance class for 3 weeks
4 meters Gait Speed Test (GST)
Measure time (in seconds) that it takes the patient to walk 4 meters. The patient should be at their usual speed during the entire 4 meter timed area. Use a 6 meter path, with the central 4 meters as the timed area. Patient may use any walking aid.
Measured: after attending balance class for 3 weeks
Falls Efficacy Scale (FES)
A 10-item questionnaire for patients to rate their confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all").
Measured: after attending balance class for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start10 Apr 2017 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Cayer, University of British Columbia
- Investigators
- Marian Cayer, BSc, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110237
- Sponsor's protocol ID
- H16-02866
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
PubMed 24756870Winter D. A.B.C.(Anatomy, Biomechanics and Control) of Balance During Standing and Walking. Waterloo: Waterloo Biomechanics; 1995.
Annabel McDermott, OT; Nicol Korner-Bitensky, PhD OT; Norine Foley, BASc; Mark Speechley, PhD; Nancy M. Salbach, PhD, PT; Maxim Ben Yakov, BSc. PT; Robert Teasell, MD. (2012). Balance Training. Retrieved from http://www.strokengine.ca/intervention/balance-training/
Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.
PubMed 20716987An M, Shaughnessy M. The effects of exercise-based rehabilitation on balance and gait for stroke patients: a systematic review. J Neurosci Nurs. 2011 Dec;43(6):298-307. doi: 10.1097/JNN.0b013e318234ea24.
PubMed 22089406Ottawa Panel; Khadilkar A, Phillips K, Jean N, Lamothe C, Milne S, Sarnecka J. Ottawa panel evidence-based clinical practice guidelines for post-stroke rehabilitation. Top Stroke Rehabil. 2006 Spring;13(2):1-269. doi: 10.1310/3TKX-7XEC-2DTG-XQKH.
PubMed 16939981Lindsay MP, Gubitz G, Bayley M, Hill MD, Davies-Schinkel C, Singh S, and Phillips S. Canadian Best Practice Recommendations for Stroke Care (Update 2010). On behalf of the Canadian Stroke Strategy Best Practices and Standards Writing Group. 2010; Ottawa, Ontario Canada: Canadian Stroke Network.
Richards CL, Malouin F, Wood-Dauphinee S, Williams JI, Bouchard JP, Brunet D. Task-specific physical therapy for optimization of gait recovery in acute stroke patients. Arch Phys Med Rehabil. 1993 Jun;74(6):612-20. doi: 10.1016/0003-9993(93)90159-8.
PubMed 8503751McClellan R, Ada L. A six-week, resource-efficient mobility program after discharge from rehabilitation improves standing in people affected by stroke: placebo-controlled, randomised trial. Aust J Physiother. 2004;50(3):163-7. doi: 10.1016/s0004-9514(14)60154-9.
PubMed 15482247Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.
PubMed 18780882Alptekin N, Gok H, Geler-Kulcu D, Dincer G. Efficacy of treatment with a kinaesthetic ability training device on balance and mobility after stroke: a randomized controlled study. Clin Rehabil. 2008 Oct-Nov;22(10-11):922-30. doi: 10.1177/0269215508090673.
PubMed 18955424Karthikbabu S, Nayak A, Vijayakumar K, Misri Z, Suresh B, Ganesan S, Joshua AM. Comparison of physio ball and plinth trunk exercises regimens on trunk control and functional balance in patients with acute stroke: a pilot randomized controlled trial. Clin Rehabil. 2011 Aug;25(8):709-19. doi: 10.1177/0269215510397393. Epub 2011 Apr 19.
PubMed 21504955Sackley CM, Lincoln NB. Single blind randomized controlled trial of visual feedback after stroke: effects on stance symmetry and function. Disabil Rehabil. 1997 Dec;19(12):536-46. doi: 10.3109/09638289709166047.
PubMed 9442992Morioka S, Yagi F. Effects of perceptual learning exercises on standing balance using a hardness discrimination task in hemiplegic patients following stroke: a randomized controlled pilot trial. Clin Rehabil. 2003 Sep;17(6):600-7. doi: 10.1191/0269215503cr654oa.
PubMed 12971704Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.
PubMed 14966713
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI
- ClinicalTrials.gov ID
- NCT03110237
- Acronym / sponsor ID
- H16-02866
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 10 Apr 2017 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 12 Apr 2017 (actual)
- 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.
Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased risks of falls. Previous studies indicate that balance training improves balance, reduces falls, and increases walking speed and balance confidence. The purpose of this study is to determine if a multidimensional balance training based on the FallProof(TM) approach achieves better improvements in balance and walking performance than the current practice . Participants will be assigned to: 1)a task-oriented circuit training balance class (current practice), or 2) balance training class based on the FallProof(TM) approach. Standardized tests will determine if participating in balance training helps improve balance, walking speed and balance confidence.
Detailed description
The purpose of this pilot research study is to determine if a balance training (BT) class based on the FallProof(TM) approach achieves better balance and mobility outcomes than the current practice. The FallProof's approach focuses on multiple components of balance impairment including multisensory, postural strategy and centre of gravity control training. Current practice is a task-oriented circuit training balance class.
ABI survivors may have muscle weakness, decreased coordination and sensory loss, which contribute to reduced balance, difficulty with functional mobility and activities of daily living. Balance control provides the foundation for a person's ability to stand, walk and function independently. Previous studies indicate that balance training (BT) improves balance, reduces falls, increases walking speed and balance self-efficacy for ABI patients .The Ottawa Panel Evidence-Based Clinical Practice Guidelines for ABI Rehabilitation supported the use of BT based on the research evidence. Interventions such as task-oriented training, multisensory training, trunk control training and perceptual exercises demonstrate positive effect on balance and mobility outcomes. To our knowledge, there are few studies that have examined a multidimensional approach to BT.
A systematic review concluded that exercises performed for 20-60 minutes, 3-4 times a week for 6-12 weeks can improve balance in ABI patients. However, Treacy et al demonstrated that inpatient BT for just 2 weeks can improve balance compared to a control group who received traditional exercise interventions.
At GF Strong Rehabilitation Center (GFS), the usual care provided to the ambulatory ABI patients consists of individualized one to one physiotherapy treatment, as well as a high level BT class. Currently, this BT class is a circuit training class that focuses on task-oriented gait exercises. FallProof balance training is a group- based approach that includes multisensory, postural strategy, centre of gravity control and gait pattern training. It was originally developed for older adults with impaired balance; but there is no research on the effectiveness of this approach for ABI patients. The FallProof approach has been introduced to the low level and intermediate level BT class at GFS, for ABI patients with sever and moderate balance impairments. These classes received positive feedback from patients and therapists. Patients reported improved functional mobility and confidence after attending the class. However, there was no functional outcome measurements collected to compare the effectiveness of the previous class and the new FallProof class. We plan to modify the current circuit training high level balance class with the FallProof approach in the spring of 2017. Before introducing the FallProof class, we would like to collect outcome measures with the current BT class for three months, and then collect collect data with the new class for comparison. We would like to determine if a multidimensional group based BT treatment approach is more effective at improving functional outcomes compared to the current practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Balance Training (BT) class | Active comparator | Other: Control Balance Training (BT) classGroup based circuit training class, 30 minute session, twice a week for three weeks |
| Fallproof Balance Training (BT) class | Experimental | Other: Fallproof Balance Training (BT) classGroup based balance training class based on the FallProof(TM) approach, 30 minute session , twice a week for three weeks |
Who may qualify
- Ages
- 16 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- inpatients admitted to GFS with a diagnosis of ABI;
- medical stability
- has the cognitive ability to understand and follow instructions and participate in a class setting
- a Berg Balance Score of ≥52;
- able to walk independently with or without a mobility aid.
Key exclusion criteria (1 listed)
- 1) unable to attend class in a group setting and/or unable to follow instructions.
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 |
|---|---|---|
| Control Balance Training (BT) classCircuit training class with 11 stations, including: step-ups, ball kicking, balance beam, sit to stand, walk and carry, tandem walking, walking over a mat, walking up a ramp, walking at different speeds, speed walk, dual task walking. | Other | Control Balance Training (BT) class |
| Fallproof Balance Training (BT) classThere are four categories of exercises in this approach including: center of gravity control training (e.g. multi-directional weight shifts in standing, standing with altered base of support), multisensory training (e.g. standing on compliant surfaces, eyes open/closed), postural strategy training (e.g. resisted perturbation to facilitate ankle, hip or step strategy), and gait pattern variation training (e.g. walking with altered base of support , walking over and around obstacles). Each training category will be allocated 5 minutes with two exercises in each category. An additional 5 minutes will be allotted for games to challenge balance (balloon volleyball, pass the potato, circle soccer).There will be opportunity for group discussion and observational learning. | Other | Fallproof Balance Training (BT) class |
Primary outcome
Community Balance and Mobility Scale (CB & M)
Time frame: after attending balance class for 3 weeks
A performance measure composed of 13 challenging tasks. Item scores range from 0 to 5 and reflect progressive task difficulty. All tasks performed without ambulation aides.
3 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: after attending balance class for 3 weeks
4 meters Gait Speed Test (GST)
Time frame: after attending balance class for 3 weeks
Falls Efficacy Scale (FES)
Time frame: after attending balance class for 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Background: PubMed 24756870Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- BackgroundWinter D. A.B.C.(Anatomy, Biomechanics and Control) of Balance During Standing and Walking. Waterloo: Waterloo Biomechanics; 1995.
- BackgroundAnnabel McDermott, OT; Nicol Korner-Bitensky, PhD OT; Norine Foley, BASc; Mark Speechley, PhD; Nancy M. Salbach, PhD, PT; Maxim Ben Yakov, BSc. PT; Robert Teasell, MD. (2012). Balance Training. Retrieved from http://www.strokengine.ca/intervention/balance-training/
- Background: PubMed 20716987Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.
- Background: PubMed 22089406An M, Shaughnessy M. The effects of exercise-based rehabilitation on balance and gait for stroke patients: a systematic review. J Neurosci Nurs. 2011 Dec;43(6):298-307. doi: 10.1097/JNN.0b013e318234ea24.
- Background: PubMed 16939981Ottawa Panel; Khadilkar A, Phillips K, Jean N, Lamothe C, Milne S, Sarnecka J. Ottawa panel evidence-based clinical practice guidelines for post-stroke rehabilitation. Top Stroke Rehabil. 2006 Spring;13(2):1-269. doi: 10.1310/3TKX-7XEC-2DTG-XQKH.
- BackgroundLindsay MP, Gubitz G, Bayley M, Hill MD, Davies-Schinkel C, Singh S, and Phillips S. Canadian Best Practice Recommendations for Stroke Care (Update 2010). On behalf of the Canadian Stroke Strategy Best Practices and Standards Writing Group. 2010; Ottawa, Ontario Canada: Canadian Stroke Network.
- Background: PubMed 8503751Richards CL, Malouin F, Wood-Dauphinee S, Williams JI, Bouchard JP, Brunet D. Task-specific physical therapy for optimization of gait recovery in acute stroke patients. Arch Phys Med Rehabil. 1993 Jun;74(6):612-20. doi: 10.1016/0003-9993(93)90159-8.
- Background: PubMed 15482247McClellan R, Ada L. A six-week, resource-efficient mobility program after discharge from rehabilitation improves standing in people affected by stroke: placebo-controlled, randomised trial. Aust J Physiother. 2004;50(3):163-7. doi: 10.1016/s0004-9514(14)60154-9.
- Background: PubMed 18780882Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.
- Background: PubMed 18955424Alptekin N, Gok H, Geler-Kulcu D, Dincer G. Efficacy of treatment with a kinaesthetic ability training device on balance and mobility after stroke: a randomized controlled study. Clin Rehabil. 2008 Oct-Nov;22(10-11):922-30. doi: 10.1177/0269215508090673.
- Background: PubMed 21504955Karthikbabu S, Nayak A, Vijayakumar K, Misri Z, Suresh B, Ganesan S, Joshua AM. Comparison of physio ball and plinth trunk exercises regimens on trunk control and functional balance in patients with acute stroke: a pilot randomized controlled trial. Clin Rehabil. 2011 Aug;25(8):709-19. doi: 10.1177/0269215510397393. Epub 2011 Apr 19.
- 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.
Marian Cayer, BSc principal investigator
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fallproof Balance Training (BT) class in people with Brain Injuries, Traumatic and Cerebrovascular Trauma, run by University of British Columbia at 1 site in Canada.
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 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 12 Apr 2017. 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 Canada. 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 Sophia Zhao, MPT (604-734-1313 ext. 2549, sophia.zhao@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Balance and Mobility Scale (CB & M) (time frame: after attending balance class for 3 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 NCT03110237, which also lists 26 linked publications.
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 12 Apr 2017.