Clinical trial NCT03478228: Multi-Sensory Training and Wrist Fractures
Official title: Balance Among People With Fall-related Wrist Fractures and Effects of Sensory Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Keywords: fracture
rehabilitation
wrist
sensation
exercise
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 informed consent for participation in the study

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

Primary outcomes:
measure: Sensory Organization Test (SOT)
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: University of Iceland
Study officials:
affiliation: Landspitali National University Hospital
name: Palmi V Jonsson, MD
role: STUDY_CHAIR
References: