Postural BalanceNCT03478228
Multi-Sensory Training and Wrist Fractures
A study testing Multi-Sensory Training in people with Postural Balance, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
The aim of the study is to investigate whether individuals with fall-related wrist fractures have impaired posterior control, reduced proprioception in their lower limbs and/or vestibular asymmetry compared with those who have not fallen and sustained a fracture. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Multi-Sensory Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIceland
- Study dates
- 15 May 2015to 25 May 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50-75 years
- Sustained a fall-related wrist fracture
- Mentally and physically able to understand and undergo the study measurements and training.
- Able to walk 30 metres unsupported or with an aid of a stick/crutch
- Able to stand unsupported for ten minutes
- Normal corrective vision
- Have signed an informed consent for participation in the study
Who cannot join
- Confirmed diagnosis of degenerative Central Nervous System (CNS) diseases, such as Parkinson, Alzheimer and other diseases impairing mobility and cognitive function and hence precluding participation in the study.
- More detailed exclusions criteria:
- Previous history of stroke
- Parkinson
- MS
- Multisystem atrophy
Show all 11Show fewer
- Motor neuron disease
- Dementia, decline of cognitive function
- Serious mental illness
- Amputation in lower limbs
- Epilepsy on medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Among People With Fall-related Wrist Fractures and Effects of Sensory Training
The aim of the study is to investigate whether individuals with fall-related wrist fractures have impaired posterior control, reduced proprioception in their lower limbs and/or vestibular asymmetry compared with those who have not fallen and sustained a fracture. Secondly to investigate the effects of a new balance training method, directed at the sensory systems and training of fall-preventive movements on postural control and how it impacts the function of the sensory systems. Postural instability falls and fractures form one of the major problems associated with ageing. An association of vestibular- asymmetry with falls and fractures has been found and reduced vibration sensation in the lower limbs has been connected with imbalance. Wrist fractures are often precursor to the more serious hip fractures, which often result in decreased quality of life, even death and are costly for the society. Subjects will be individuals 50-75 years of age having sustained a fall-related wrist fracture. Measurements of sensory functions, postural control and functional ability will be conducted before and after balance training. Confidence in daily activities and self-perceived dizziness handicap will be obtained with questionnaires. The same evaluations will be performed on age and gender matched individuals without previous history of fall-related wrist fractures. This research might reveal the presence and frequency of vestibular asymmetry or/and other age related degenerative changes in the sensory systems, which decrease stability and increase the risk of falls and fractures. It could show preventive effects of specific balance training on fall risk, and thus increase quality of life of the individuals, improve healthcare services and decrease costs associated with falls and fractures.
- Conditions
- Postural Balance
- Being tested
- Multi-Sensory Training
- Keywords
- fracture, rehabilitation, wrist, sensation, exercise
- Medical subject headings
- Fractures, Bone, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Sensory TrainingOther
Also called Wrist Stabilisation Training
| Study group | Role | What they receive |
|---|---|---|
| Multi-Sensory Training (MST) | Experimental | Multi-Sensory Training. 6 treatment sessions, supervised by a physiotherapist, during a 3 months training period, and a written exercise program that is to be performed daily at home. The participants keep a home exercise diary during the training period. Receives: Other: Multi-Sensory Training |
| Wrist Stabilisation Training (WT) | Active comparator | Wrist Stabilisation Training. 6 treatment sessions, supervised by a physiotherapist, during a 3 months training period, and a written exercise program that is to be performed daily at home. The participants keep a home exercise diary during the training period. Receives: Other: Multi-Sensory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Organization Test (SOT)
Balance measurement
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start15 May 2015
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Palmi V Jonsson, MD, Study chair, Landspitali National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478228
- Sponsor's protocol ID
- 2013 16 ÓB/eí
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Among People With Fall-related Wrist Fractures and Effects of Sensory Training
- ClinicalTrials.gov ID
- NCT03478228
- Acronym / sponsor ID
- 2013 16 ÓB/eí
- Conditions
- Postural Balance
- Keywords
- fracture, rehabilitation, wrist, sensation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Study start
- 15 May 2015 (actual)
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 27 Mar 2018 (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.
The aim of the study is to investigate whether individuals with fall-related wrist fractures have impaired posterior control, reduced proprioception in their lower limbs and/or vestibular asymmetry compared with those who have not fallen and sustained a fracture. Secondly to investigate the effects of a new balance training method, directed at the sensory systems and training of fall-preventive movements on postural control and how it impacts the function of the sensory systems. Postural instability falls and fractures form one of the major problems associated with ageing. An association of vestibular- asymmetry with falls and fractures has been found and reduced vibration sensation in the lower limbs has been connected with imbalance. Wrist fractures are often precursor to the more serious hip fractures, which often result in decreased quality of life, even death and are costly for the society. Subjects will be individuals 50-75 years of age having sustained a fall-related wrist fracture. Measurements of sensory functions, postural control and functional ability will be conducted before and after balance training. Confidence in daily activities and self-perceived dizziness handicap will be obtained with questionnaires. The same evaluations will be performed on age and gender matched individuals without previous history of fall-related wrist fractures. This research might reveal the presence and frequency of vestibular asymmetry or/and other age related degenerative changes in the sensory systems, which decrease stability and increase the risk of falls and fractures. It could show preventive effects of specific balance training on fall risk, and thus increase quality of life of the individuals, improve healthcare services and decrease costs associated with falls and fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Sensory Training (MST) | Experimental | Other: Multi-Sensory TrainingMulti-Sensory Training. 6 treatment sessions, supervised by a physiotherapist, during a 3 months training period, and a written exercise program that is to be performed daily at home. The participants keep a home exercise diary during the training period. |
| Wrist Stabilisation Training (WT) | Active comparator | Other: Multi-Sensory TrainingWrist Stabilisation Training. 6 treatment sessions, supervised by a physiotherapist, during a 3 months training period, and a written exercise program that is to be performed daily at home. The participants keep a home exercise diary during the training period. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 50-75 years
- Sustained a fall-related wrist fracture
- Mentally and physically able to understand and undergo the study measurements and training.
- Have signed an informed consent for participation in the study
Key exclusion criteria (11 listed)
- Confirmed diagnosis of degenerative Central Nervous System (CNS) diseases, such as Parkinson, Alzheimer and other diseases impairing mobility and cognitive function and hence precluding participation in the study.
- Previous history of stroke
- Parkinson
- MS
- Multisystem atrophy
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 |
|---|---|---|
| Multi-Sensory TrainingAlso: Wrist Stabilisation Training | Other | Multi-Sensory Training (MST), Wrist Stabilisation Training (WT) |
Primary outcome
Sensory Organization Test (SOT)
Time frame: 14 weeks
Balance measurement
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 27 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Postural Balance
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"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
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Cerebello-Cortical Connectivity and Balance Adaptation in Younger and Older Adults
Aging, Postural Balance
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Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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.
Palmi V Jonsson, MD study chair
Landspitali National University 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 Multi-Sensory Training in people with Postural Balance, run by Landspitali University Hospital at 1 site in Iceland.
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 7 inclusion and 11 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 27 Mar 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 Iceland. 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?
Sensory Organization Test (SOT) (time frame: 14 weeks). 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 27 Mar 2018.