Multi-Sensory Training and Wrist Fractures

March 23, 2018 updated by: Landspitali University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavik, Iceland, 101
        • University of Iceland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • Wrist Stabilisation 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
Other Names:
  • Wrist Stabilisation Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Organization Test (SOT)
Time Frame: 14 weeks
Balance measurement
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landspitali University Hospital

Investigators

  • Study Chair: Palmi V Jonsson, MD, Landspitali National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2015

Primary Completion (ACTUAL)

May 25, 2016

Study Completion (ACTUAL)

May 25, 2016

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (ACTUAL)

March 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013 16 ÓB/eí

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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