Neurological Diseases or ConditionsNCT05526508
Rebound Exercise in Neurological Disorders
A study testing Rebound exercise in people with Neurological Diseases or Conditions, run by Buckinghamshire New University at 2 sites in United Kingdom.
Trial summary
This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurological Diseases or Conditions
- What is being tested?
- Rebound exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Dec 2022to 31 Jul 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, Parkinson's disease, traumatic brain injury etc
- must score 3 or less on the Modified Rankin Scale for disability status
- must be able to walk with or without walking aids for at least 2 minutes
- have a body weight of <120 kg
- must be able to understand therapy instructions.
Who cannot join
- Pregnancy
- Other significant comorbidities
- cardiovascular or respiratory system disorders
- musculoskeletal disorders
- visual or auditory sensory disorders.
- cancer
- genu recurvatum
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Buckinghamshire New University
Aylesbury, Buckinghamshire, HP21 7QG
Adaora J Okemuo, 07883733407, Adaora.Okemuo@bucks.ac.uk
- Recruiting
Buckinghamshire New University
High Wycombe, Buckinghamshire, HP11 2JZ
Adaora J Okemuo, 07883733407, Adaora.Okemuo@bucks.ac.uk
About this study
Official title: Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders
This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.
Read the detailed description
Neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. These impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. Rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. It can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. Its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. It is also more affordable and less time-consuming than other standard modalities. The few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. It is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. This study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. The enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice.
Ethical approval has been sought and obtained from the Research Ethics Committee of Buckinghamshire New University. Eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. They will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.
- Conditions
- Neurological Diseases or Conditions
- Being tested
- Rebound exercise
- Keywords
- neurological disorders, rebound, mini-trampoline, exercise /therapy, walking speed, fall risk, quality of life
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebound exerciseDevice
Exercise training on the rebounder/ mini-trampoline with stability handles attached
| Study group | Role | What they receive |
|---|---|---|
| Rebound once-weekly | Experimental | This group will undergo 12 weeks of rebound exercise training once weekly, for 30 minutes per session. Receives: Device: Rebound exercise |
| Rebound twice-weekly | Experimental | This group will undergo 12 weeks of rebound exercise training twice weekly, for 30 minutes per session. Receives: Device: Rebound exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks
3-metre backward walk test (3MBWT) is valid, reliable and clinically suitable to detect little changes in motor functions related to proprioception in patients with neurological diseases (Kocaman et al., 2021). Of all battery tests assessed for fall risks in patients with Parkinson's disease (Carter et al., 2020), 3MBWT had the highest overall accuracy for retrospective falls. Backward walking measures are more sensitive to identify age-related changes in mobility than forward walking. From a marked point, the patient is asked to walk backwards as fast and safely as possible to a 3-metre marked end. They are free to look back if they wish. A time of 3 seconds or less indicates good balance and low fall risk, while a time of 4.5 seconds or more indicates a high fall risk.
Measured: Baseline and12 weeks
Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks
10MWT has been shown to have excellent construct validity and reliability for patients with neurological diseases (Cheng et al., 2020). The individual is instructed to walk a set distance of 10 meters, and the time taken to walk the distance is noted. Assistive devices may be used but must be documented from test to test. Walking distance is measured in meters per second.
Measured: Baseline and 12 weeks
Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks
WHOQOLBREF is a 12-item questionnaire assessing physical and psychological domains of quality of life. The scale has been validated among stroke patients of different ethnic groups (Kerber et al., 2013; Post et al., 2011). It is rated on a 5-point Likert scale ranging from 1-5, with higher scores indicating better quality of life. A significant advantage it has over the more extended version is its reduced administration time (5 minutes), making it a more practical tool in research and clinical practice.
Measured: Baseline and12 weeks
Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally.
Measured: Baseline and 12 weeks
Change in baseline cognitive function assessed by mini-cog at 12 weeks
The Mini-Cog is a simple screening test for cognitive impairment. It combines a brief memory test and a scored clock-drawing test. It allows rapid screening for short-term memory defects, learning and different cognitive abilities impaired in dementia patients.
Measured: Baseline and 12 weeks
Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks
A digital Blood pressure monitor uses an inflatable air-bladder cuff, a battery-powered air pump and a pressure sensor for sensing arterial wall vibrations to measure blood pressure in an artery.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks
A Hand-Held Dynamometer is a valid and reliable assessment tool used for objectively quantifying muscle strength
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start12 Dec 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- 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
- Model description
- There will be two frequency groups, once-weekly and twice-weekly, but the group's choice depends on the participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire New University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adaora Okemuo, Buckinghamshire New University
- Investigators
- Yetunde M Dairo, PhD, Study director, Buckinghamshire New UniversityDearbhla Gallagher, PhD, Study chair, Buckinghamshire New University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526508
- Sponsor's protocol ID
- BNU2022Okemuo
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised data information necessary for publication of the study findings will be shared with the researchers
Publications
Bhattacharya A, McCutcheon EP, Shvartz E, Greenleaf JE. Body acceleration distribution and O2 uptake in humans during running and jumping. J Appl Physiol Respir Environ Exerc Physiol. 1980 Nov;49(5):881-7. doi: 10.1152/jappl.1980.49.5.881.
PubMed 7429911Cugusi L, Manca A, Serpe R, Romita G, Bergamin M, Cadeddu C, Solla P, Mercuro G; Working Group of Gender Cardiovascular Disease of the Italian Society of Cardiology. Effects of a mini-trampoline rebounding exercise program on functional parameters, body composition and quality of life in overweight women. J Sports Med Phys Fitness. 2018 Mar;58(3):287-294. doi: 10.23736/S0022-4707.16.06588-9. Epub 2016 Jul 21.
PubMed 27441918Unver B, Sevik K, Yarar HA, Unver F, Karatosun V. Reliability of 3-m Backward Walk Test in Patients with Primary Total Knee Arthroplasty. J Knee Surg. 2020 Jun;33(6):589-592. doi: 10.1055/s-0039-1681099. Epub 2019 Mar 12.
PubMed 30861540Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13.
PubMed 33197801Cheng DK, Nelson M, Brooks D, Salbach NM. Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways. Top Stroke Rehabil. 2020 May;27(4):251-261. doi: 10.1080/10749357.2019.1691815. Epub 2019 Nov 21.
PubMed 31752634Kerber KA, Brown DL, Skolarus LE, Morgenstern LB, Smith MA, Garcia NM, Lisabeth LD. Validation of the 12-item stroke-specific quality of life scale in a biethnic stroke population. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1270-2. doi: 10.1016/j.jstrokecerebrovasdis.2012.08.011. Epub 2012 Sep 18.
PubMed 22995379Post MW, Boosman H, van Zandvoort MM, Passier PE, Rinkel GJ, Visser-Meily JM. Development and validation of a short version of the Stroke Specific Quality of Life Scale. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):283-6. doi: 10.1136/jnnp.2009.196394. Epub 2010 Aug 27.
PubMed 20802211Burandt P, Porcari JP, Cress ML, Doberstein S, Foster C, Green DJ (2016). ACE-Sponsored research: Putting mini-trampolines to the test. ACE Prosource. Available at www.acefitness.org Retrieved on 21/07/2022.
Centers for Disease Control and Prevention (2022). Stroke statistics. CDC Wonder Online Database. Available at www.cdc.gov/stroke/facts Retrieved 21/07/2022
Carter, V.A., Farley, B.G., Wing, K. and Jain, T.K., 2020. Diagnostic accuracy of the 3-meter backward walk test in persons with parkinson disease. Topics in Geriatric Rehabilitation, 36(3), pp.140-145
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders
- ClinicalTrials.gov ID
- NCT05526508
- Acronym / sponsor ID
- BNU2022Okemuo
- Conditions
- Neurological Diseases or Conditions
- Keywords
- neurological disorders, rebound, mini-trampoline, exercise /therapy, walking speed, fall risk, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Buckinghamshire New UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Sep 2022 (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.
This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.
Detailed description
Neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. These impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. Rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. It can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. Its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. It is also more affordable and less time-consuming than other standard modalities. The few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. It is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. This study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. The enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice.
Ethical approval has been sought and obtained from the Research Ethics Committee of Buckinghamshire New University. Eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. They will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two frequency groups, once-weekly and twice-weekly, but the group's choice depends on the participants.
| Arm | Type | Receives |
|---|---|---|
| Rebound once-weekly | Experimental | Device: Rebound exerciseThis group will undergo 12 weeks of rebound exercise training once weekly, for 30 minutes per session. |
| Rebound twice-weekly | Experimental | Device: Rebound exerciseThis group will undergo 12 weeks of rebound exercise training twice weekly, for 30 minutes per session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, Parkinson's disease, traumatic brain injury etc
- must score 3 or less on the Modified Rankin Scale for disability status
- must be able to walk with or without walking aids for at least 2 minutes
- have a body weight of <120 kg
- must be able to understand therapy instructions.
Key exclusion criteria (7 listed)
- Pregnancy
- Other significant comorbidities
- cardiovascular or respiratory system disorders
- musculoskeletal disorders
- visual or auditory sensory disorders.
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 |
|---|---|---|
| Rebound exerciseExercise training on the rebounder/ mini-trampoline with stability handles attached | Device | Rebound once-weekly, Rebound twice-weekly |
Primary outcome
Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks
Time frame: Baseline and12 weeks
3-metre backward walk test (3MBWT) is valid, reliable and clinically suitable to detect little changes in motor functions related to proprioception in patients with neurological diseases (Kocaman et al., 2021). Of all battery tests assessed for fall risks in patients with Parkinson's disease (Carter et al., 2020), 3MBWT had the highest overall accuracy for retrospective falls. Backward walking measures are more sensitive to identify age-related changes in mobility than forward walking. From a marked point, the patient is asked to walk backwards as fast and safely as possible to a 3-metre marked end. They are free to look back if they wish. A time of 3 seconds or less indicates good balance and low fall risk, while a time of 4.5 seconds or more indicates a high fall risk.
Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks
Time frame: Baseline and 12 weeks
10MWT has been shown to have excellent construct validity and reliability for patients with neurological diseases (Cheng et al., 2020). The individual is instructed to walk a set distance of 10 meters, and the time taken to walk the distance is noted. Assistive devices may be used but must be documented from test to test. Walking distance is measured in meters per second.
Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks
Time frame: Baseline and12 weeks
WHOQOLBREF is a 12-item questionnaire assessing physical and psychological domains of quality of life. The scale has been validated among stroke patients of different ethnic groups (Kerber et al., 2013; Post et al., 2011). It is rated on a 5-point Likert scale ranging from 1-5, with higher scores indicating better quality of life. A significant advantage it has over the more extended version is its reduced administration time (5 minutes), making it a more practical tool in research and clinical practice.
Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks
Time frame: Baseline and 12 weeks
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally.
Change in baseline cognitive function assessed by mini-cog at 12 weeks
Time frame: Baseline and 12 weeks
The Mini-Cog is a simple screening test for cognitive impairment. It combines a brief memory test and a scored clock-drawing test. It allows rapid screening for short-term memory defects, learning and different cognitive abilities impaired in dementia patients.
Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks
Time frame: Baseline and 12 weeks
A digital Blood pressure monitor uses an inflatable air-bladder cuff, a battery-powered air pump and a pressure sensor for sensing arterial wall vibrations to measure blood pressure in an artery.
1 secondary outcome
Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 7429911Bhattacharya A, McCutcheon EP, Shvartz E, Greenleaf JE. Body acceleration distribution and O2 uptake in humans during running and jumping. J Appl Physiol Respir Environ Exerc Physiol. 1980 Nov;49(5):881-7. doi: 10.1152/jappl.1980.49.5.881.
- Background: PubMed 27441918Cugusi L, Manca A, Serpe R, Romita G, Bergamin M, Cadeddu C, Solla P, Mercuro G; Working Group of Gender Cardiovascular Disease of the Italian Society of Cardiology. Effects of a mini-trampoline rebounding exercise program on functional parameters, body composition and quality of life in overweight women. J Sports Med Phys Fitness. 2018 Mar;58(3):287-294. doi: 10.23736/S0022-4707.16.06588-9. Epub 2016 Jul 21.
- Background: PubMed 30861540Unver B, Sevik K, Yarar HA, Unver F, Karatosun V. Reliability of 3-m Backward Walk Test in Patients with Primary Total Knee Arthroplasty. J Knee Surg. 2020 Jun;33(6):589-592. doi: 10.1055/s-0039-1681099. Epub 2019 Mar 12.
- Background: PubMed 33197801Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13.
- Background: PubMed 31752634Cheng DK, Nelson M, Brooks D, Salbach NM. Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways. Top Stroke Rehabil. 2020 May;27(4):251-261. doi: 10.1080/10749357.2019.1691815. Epub 2019 Nov 21.
- Background: PubMed 22995379Kerber KA, Brown DL, Skolarus LE, Morgenstern LB, Smith MA, Garcia NM, Lisabeth LD. Validation of the 12-item stroke-specific quality of life scale in a biethnic stroke population. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1270-2. doi: 10.1016/j.jstrokecerebrovasdis.2012.08.011. Epub 2012 Sep 18.
- Background: PubMed 20802211Post MW, Boosman H, van Zandvoort MM, Passier PE, Rinkel GJ, Visser-Meily JM. Development and validation of a short version of the Stroke Specific Quality of Life Scale. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):283-6. doi: 10.1136/jnnp.2009.196394. Epub 2010 Aug 27.
- BackgroundBurandt P, Porcari JP, Cress ML, Doberstein S, Foster C, Green DJ (2016). ACE-Sponsored research: Putting mini-trampolines to the test. ACE Prosource. Available at www.acefitness.org Retrieved on 21/07/2022.
- BackgroundCenters for Disease Control and Prevention (2022). Stroke statistics. CDC Wonder Online Database. Available at www.cdc.gov/stroke/facts Retrieved 21/07/2022
- BackgroundCarter, V.A., Farley, B.G., Wing, K. and Jain, T.K., 2020. Diagnostic accuracy of the 3-meter backward walk test in persons with parkinson disease. Topics in Geriatric Rehabilitation, 36(3), pp.140-145
- Individual participant dataSharing planned: Yes. The anonymised data information necessary for publication of the study findings will be shared with the researchers
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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.
Yetunde M Dairo, PhD study director
Buckinghamshire New University
Dearbhla Gallagher, PhD study chair
Buckinghamshire New University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebound exercise in people with Neurological Diseases or Conditions, run by Buckinghamshire New University at 2 sites in United Kingdom.
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 7 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 Adaora J Okemuo, M.Sc (07883733407, Adaora.Okemuo@bucks.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks (time frame: Baseline and12 weeks). The study lists 6 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 NCT05526508, which also lists 10 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 15 Feb 2023.