Parkinson DiseaseNCT04048291
Efficacy of Brisk Walking in Parkinson's Disease
A study testing Brisk walking and balance training and Upper limb exercise in people with Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Parkinson's disease (PD) is the second most common neuro-degenerative disease in older people. Falls are common among people PD with the incidence rate up to 70% and have strong associations with the severity of the disease, balance impairment, and freezing of gait.The abnormal gait characteristics include reduction… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Brisk walking and balance training and Upper limb exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2018to 28 Feb 2020
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson disease diagnosed by neurologist with Hoehn \& Yahr stage 2 or 3
- Having a 30-meter walking ability
Who cannot join
- Significant neurological condition (other than Parkinson's disease)
- Musculoskeletal conditions affecting gait, balance or upper limb functions
- Had received deep brain stimulation surgery
- Cognitive impairment with Montreal Cognitive Assessment score <24
- Present with on-off motor fluctuations.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong, Nothing Selected, 0000
About this study
Official title: Efficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled Trial
Parkinson's disease (PD) is the second most common neuro-degenerative disease in older people. Falls are common among people PD with the incidence rate up to 70% and have strong associations with the severity of the disease, balance impairment, and freezing of gait.The abnormal gait characteristics include reduction in stride length, gait speed and arm swing, and increase in cadence. Gait training, balance training, aerobic training, Tai chi and dance training are common types of physical rehabilitation for PD. Brisk walking is a way of walking with a pace faster than normal, and it can improve dynamic balance for senior men and balance function for chronic stroke clients.
Brisk walking also promotes cardiopulmonary fitness and walking endurance in elderly women, healthy middle-age and older adults, active elderly men and chronic stroke clients. Our previous pilot randomized controlled trial on the effects of a 6-week home-based brisk walking program indicates that it is feasible and safe for the early PD population with improved walking capacity measured by 6-minute walk distance. The positive effects could carry over to 6 weeks after treatment completion. Up-to-date, the short- and long-term effects of brisk walking in improving balance and gait performance, and functional capacity in people with PD have not yet been well investigated. In order to promote their balance and functional capacity in longer term, more sustained training and better exercise adherence may be necessary.
- Conditions
- Parkinson Disease
- Being tested
- Brisk walking and balance training, Upper limb exercise
- Keywords
- rehabilitation, exercise, postural balance
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk walking and balance trainingBehavioural
6 months of combined brisk walking and balance training
Upper limb exerciseBehavioural
6 month of hand dexterity training
| Study group | Role | What they receive |
|---|---|---|
| Brisk walking and balance training | Experimental | 1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session
2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session
3. Participants practice own balance exercise and brisk walking 2-3 times/week (to aim at 150 min of moderate intensity of brisk walking per week at 40-60% of heart rate reserve) Receives: Behavioral: Brisk walking and balance training |
| Upper limb exercise | Active comparator | 1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session
2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session
3. Participants practice own upper limb exercise 2-3 times/week (to aim at 150 min of exercise per week) Receives: Behavioral: Upper limb exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Balance Evaluation Systems Test (miniBest) total scores
To evaluate dynamic balance in four domains: anticipatory postural adjustments, postural reactions, sensory integration and gait stability. The miniBEST scores range from 0 to 28, with a higher score indicates better dynamic balance.
Measured: 1 year
Six-minute walking test (6MWT) distance
The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity
Measured: 1 year
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
This score consists of 18 items in 33 questions examining the motor and functional capacity of people with Parkinson's disease by the assessor. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-III score ranges from 0 to 132, with higher scores indicating more severe motor and functional impairments
Measured: 1 year
Secondary outcomes (9)
Fast gait speed
The single-task gait speed measured by a 10-meter walking test in a fast pace
Measured: 1 year
Dual-task timed-up-and-go-time
The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction
Measured: 1 year
Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
This score assesses the non-motor aspects of experiences of daily living in people with Parkinson's disease with a total of 13 questions. The score will be administered by assessor asking participants about their behaviors and non-motor symptoms such as cognitive impairment, hallucination, depressive and anxious mood, sleep, pain, urinary and constipation problems, and fatigue etc. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-I score ranges from 0 to 52, with higher scores indicating more severe non-motor impairment.
Measured: 1 year
Activities-specific Balance Confidence (ABC) Scale score
The ABC score will be used to measure the participants' perceived level of balance confidence in 16 indoor and outdoor activities. Each activity is rated from 0-100 (0 indicates no confidence and 100 indicates full confidence, total score=1600). The total score is converted into percentage score ranging from 0 to 100%, with a higher ABC score indicating a higher level of balance confidence.
Measured: 1 year
Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
It is a health-related quality-of-life outcome measure that contains 39 self-reported items on eight domains, i.e.: mobility [#1-10], activities of daily living [#11-16], emotional well-being [#17-22], stigma [#23-26], social support [#27-29], cognition [#30-33], communication [#34-36], and body discomfort [#37-39]. The PDQ-39 has been translated into Chinese and validated for local use. Each item is scored on 5-point Likert-type scales ranging from 0 (never), 1 (occasionally), 2 (sometimes), and 3 (often) to 4 (always) based on their perception on the item over the past month. The PDQ-39 total score is 156 and the PDQ-39 summary index is created by summing all eight of the PDQ-39 domains and standardizing the score on a scale of 0-100%. A lower PDQ-39 summary index score reflects a better health-related quality-of-life.
Measured: 1 year
Fall risk
The risk of falling of each group will be determined by the ratio of non-fallers to fallers at treatment completion and 6-month follow-up. A lower risk ratio indicates a lower risk of falling.
Measured: 1 year
Fall rate
The fall rate (times of fall per year per person) of each group at treatment completion and 6-month follow-up will be calculated with the following formula:
Number of fall events X12 / (Number of months spent to assemble fall data X number of subjects)
A lower fall rate indicates a better effect on fall reduction.
Measured: 1 year
Injurious fall risk
The risk of injurious falling of each group at treatment completion and 6-month follow-up will be determined by the ratio of injurious non-fallers to injurious fallers. A lower injurious risk ratio indicates a lower risk of injurious falling.
Measured: 1 year
Injurious fall rate
The injurious fall rate (times of injurious fall per year per person) of each group at treatment completion and 6-month follow-up will be calculated with the following formula:
Number of injurious fall events X12 / (Number of months spent to collect injurious fall data X number of subjects)
A lower injurious fall rate indicates a better effect on injurious fall reduction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 Oct 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Kit Yi Mak, The Hong Kong Polytechnic University
- Investigators
- Margaret K Mak, Ph.D., Principal investigator, Department of Rehabilitation Sciences,The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048291
- Sponsor's protocol ID
- HSEARS20180507003
- Status last verified
- Aug 2021
- First submitted
- 9 Oct 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bloem BR, Grimbergen YA, Cramer M, Willemsen M, Zwinderman AH. Prospective assessment of falls in Parkinson's disease. J Neurol. 2001 Nov;248(11):950-8. doi: 10.1007/s004150170047.
PubMed 11757958Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.
PubMed 17588236Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
PubMed 12023412Grimbergen YA, Munneke M, Bloem BR. Falls in Parkinson's disease. Curr Opin Neurol. 2004 Aug;17(4):405-15. doi: 10.1097/01.wco.0000137530.68867.93.
PubMed 15247535Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
PubMed 7953597Ebersbach G, Sojer M, Valldeoriola F, Wissel J, Muller J, Tolosa E, Poewe W. Comparative analysis of gait in Parkinson's disease, cerebellar ataxia and subcortical arteriosclerotic encephalopathy. Brain. 1999 Jul;122 ( Pt 7):1349-55. doi: 10.1093/brain/122.7.1349.
PubMed 10388800Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
PubMed 29027544Tully MA, Cupples ME, Chan WS, McGlade K, Young IS. Brisk walking, fitness, and cardiovascular risk: a randomized controlled trial in primary care. Prev Med. 2005 Aug;41(2):622-8. doi: 10.1016/j.ypmed.2004.11.030.
PubMed 15917061Paillard T, Lafont C, Costes-Salon MC, Riviere D, Dupui P. Effects of brisk walking on static and dynamic balance, locomotion, body composition, and aerobic capacity in ageing healthy active men. Int J Sports Med. 2004 Oct;25(7):539-46. doi: 10.1055/s-2004-820948.
PubMed 15459836Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
PubMed 23974944Blain H, Jaussent A, Picot MC, Maimoun L, Coste O, Masud T, Bousquet J, Bernard PL. Effect of a 6-Month Brisk Walking Program on Walking Endurance in Sedentary and Physically Deconditioned Women Aged 60 or Older: A Randomized Trial. J Nutr Health Aging. 2017;21(10):1183-1189. doi: 10.1007/s12603-017-0955-7.
PubMed 29188878Mak M, Chan W, Auyeung M, Chan A, Cheung N, Mok V. Effects of a home-based brisk walking program in improving activity volume and walking capacity in people with Parkinson's disease. Fourth World Parkinson Congress Abstract; September 2016; Portland 2016.
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04048291
- Acronym / sponsor ID
- HSEARS20180507003
- Conditions
- Parkinson Disease
- Keywords
- rehabilitation, exercise, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 7 Aug 2019 (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.
Parkinson's disease (PD) is the second most common neuro-degenerative disease in older people. Falls are common among people PD with the incidence rate up to 70% and have strong associations with the severity of the disease, balance impairment, and freezing of gait.The abnormal gait characteristics include reduction in stride length, gait speed and arm swing, and increase in cadence. Gait training, balance training, aerobic training, Tai chi and dance training are common types of physical rehabilitation for PD. Brisk walking is a way of walking with a pace faster than normal, and it can improve dynamic balance for senior men and balance function for chronic stroke clients.
Brisk walking also promotes cardiopulmonary fitness and walking endurance in elderly women, healthy middle-age and older adults, active elderly men and chronic stroke clients. Our previous pilot randomized controlled trial on the effects of a 6-week home-based brisk walking program indicates that it is feasible and safe for the early PD population with improved walking capacity measured by 6-minute walk distance. The positive effects could carry over to 6 weeks after treatment completion. Up-to-date, the short- and long-term effects of brisk walking in improving balance and gait performance, and functional capacity in people with PD have not yet been well investigated. In order to promote their balance and functional capacity in longer term, more sustained training and better exercise adherence may be necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brisk walking and balance training | Experimental | Behavioral: Brisk walking and balance training1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session 2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session 3. Participants practice own balance exercise and brisk walking 2-3 times/week (to aim at 150 min of moderate intensity of brisk walking per week at 40-60% of heart rate reserve) |
| Upper limb exercise | Active comparator | Behavioral: Upper limb exercise1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session 2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session 3. Participants practice own upper limb exercise 2-3 times/week (to aim at 150 min of exercise per week) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson disease diagnosed by neurologist with Hoehn \& Yahr stage 2 or 3
- Having a 30-meter walking ability
Key exclusion criteria (5 listed)
- Significant neurological condition (other than Parkinson's disease)
- Musculoskeletal conditions affecting gait, balance or upper limb functions
- Had received deep brain stimulation surgery
- Cognitive impairment with Montreal Cognitive Assessment score <24
- Present with on-off motor fluctuations.
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 |
|---|---|---|
| Brisk walking and balance training6 months of combined brisk walking and balance training | Behavioural | Brisk walking and balance training |
| Upper limb exercise6 month of hand dexterity training | Behavioural | Upper limb exercise |
Primary outcome
Mini-Balance Evaluation Systems Test (miniBest) total scores
Time frame: 1 year
To evaluate dynamic balance in four domains: anticipatory postural adjustments, postural reactions, sensory integration and gait stability. The miniBEST scores range from 0 to 28, with a higher score indicates better dynamic balance.
Six-minute walking test (6MWT) distance
Time frame: 1 year
The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
Time frame: 1 year
This score consists of 18 items in 33 questions examining the motor and functional capacity of people with Parkinson's disease by the assessor. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-III score ranges from 0 to 132, with higher scores indicating more severe motor and functional impairments
9 secondary outcomes
Fast gait speed
Time frame: 1 year
Dual-task timed-up-and-go-time
Time frame: 1 year
Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
Time frame: 1 year
Activities-specific Balance Confidence (ABC) Scale score
Time frame: 1 year
Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
Time frame: 1 year
Fall risk
Time frame: 1 year
Fall rate
Time frame: 1 year
Injurious fall risk
Time frame: 1 year
Injurious fall rate
Time frame: 1 year
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 30 Aug 2021.
- Background: PubMed 11757958Bloem BR, Grimbergen YA, Cramer M, Willemsen M, Zwinderman AH. Prospective assessment of falls in Parkinson's disease. J Neurol. 2001 Nov;248(11):950-8. doi: 10.1007/s004150170047.
- Background: PubMed 17588236Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.
- Background: PubMed 12023412Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
- Background: PubMed 15247535Grimbergen YA, Munneke M, Bloem BR. Falls in Parkinson's disease. Curr Opin Neurol. 2004 Aug;17(4):405-15. doi: 10.1097/01.wco.0000137530.68867.93.
- Background: PubMed 7953597Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
- Background: PubMed 10388800Ebersbach G, Sojer M, Valldeoriola F, Wissel J, Muller J, Tolosa E, Poewe W. Comparative analysis of gait in Parkinson's disease, cerebellar ataxia and subcortical arteriosclerotic encephalopathy. Brain. 1999 Jul;122 ( Pt 7):1349-55. doi: 10.1093/brain/122.7.1349.
- Background: PubMed 29027544Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
- Background: PubMed 15917061Tully MA, Cupples ME, Chan WS, McGlade K, Young IS. Brisk walking, fitness, and cardiovascular risk: a randomized controlled trial in primary care. Prev Med. 2005 Aug;41(2):622-8. doi: 10.1016/j.ypmed.2004.11.030.
- Background: PubMed 15459836Paillard T, Lafont C, Costes-Salon MC, Riviere D, Dupui P. Effects of brisk walking on static and dynamic balance, locomotion, body composition, and aerobic capacity in ageing healthy active men. Int J Sports Med. 2004 Oct;25(7):539-46. doi: 10.1055/s-2004-820948.
- Background: PubMed 23974944Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
- Background: PubMed 29188878Blain H, Jaussent A, Picot MC, Maimoun L, Coste O, Masud T, Bousquet J, Bernard PL. Effect of a 6-Month Brisk Walking Program on Walking Endurance in Sedentary and Physically Deconditioned Women Aged 60 or Older: A Randomized Trial. J Nutr Health Aging. 2017;21(10):1183-1189. doi: 10.1007/s12603-017-0955-7.
- BackgroundMak M, Chan W, Auyeung M, Chan A, Cheung N, Mok V. Effects of a home-based brisk walking program in improving activity volume and walking capacity in people with Parkinson's disease. Fourth World Parkinson Congress Abstract; September 2016; Portland 2016.
- 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.
Margaret K Mak, Ph.D. principal investigator
Department of Rehabilitation Sciences,The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brisk walking and balance training and Upper limb exercise in people with Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 inclusion and 5 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 30 Aug 2021. 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 Hong Kong. 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?
Mini-Balance Evaluation Systems Test (miniBest) total scores (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT04048291, which also lists 14 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 30 Aug 2021.