ClinicalTrials.gg
CompletedNCT03478228Updated Mar 27, 2018

Multi-Sensory Training and Wrist Fractures

An interventional study of Multi-Sensory Training in Postural Balance, sponsored by Landspitali University Hospital. Completed at 1 site in Iceland. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by Landspitali University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled May 2015, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Postural Balance

Keywords

  • fracture
  • rehabilitation
  • wrist
  • sensation
  • exercise
03

In context

Fractures, Bone

723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.

This study's enrollment of 150 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Landspitali University Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 for participation in the study

Exclusion criteria

Exclusion Criteria:

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
  • Motor neuron disease
  • Dementia, decline of cognitive function
  • Serious mental illness
  • Amputation in lower limbs
  • Epilepsy on medical treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Multi-Sensory Training (MST)

    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.

    Other: Multi-Sensory Training

  • Active comparator
    Wrist Stabilisation Training (WT)

    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.

    Other: Multi-Sensory Training

Interventions

  • OtherMulti-Sensory Training

    Also known as: Wrist Stabilisation Training

06

What researchers measure

Primary outcomes

  1. Sensory Organization Test (SOT)

    Balance measurement

    Time frame: 14 weeks

07

Study locations

1 site
  • University of Iceland
    Reykjavik, 101, Iceland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2015 to primary completion in May 2016, 12 months.

Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 12 months is below that.

Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 27, 2018
StartActual
May 15, 2015
Primary completionActual
May 25, 2016
CompletionActual
May 25, 2016
Last update
Mar 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03478228
Lead sponsor
Landspitali University Hospital
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
May 15, 2015
Primary completion
May 25, 2016
Completion
May 25, 2016
Last update
Mar 27, 2018

Study contacts

Palmi V Jonsson, MD
study chair · Landspitali National University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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