Multi-Sensory Training and Wrist Fractures

Postural Balance Clinical Trial

Official title:

Balance Among People With Fall-related Wrist Fractures and Effects of Sensory Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478228
• Other study ID #: 2013 16 ÓB/eí
• Status: Completed
• Phase: N/A
• First received: March 19, 2018
• Last updated: March 23, 2018
• Start date: May 15, 2015
• Est. completion date: May 25, 2016

Study information

• Verified date: March 2018
• Source: Landspitali University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 25, 2016
• Est. primary completion date: May 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Postural Balance

Intervention

Other:
• Multi-Sensory Training

Locations

Country	Name	City	State
Iceland	University of Iceland	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Landspitali University Hospital

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Organization Test (SOT)	Balance measurement	14 weeks