NCT03478228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 19, 2018

Last Update Submit

March 23, 2018

Conditions

Keywords

fracturerehabilitationwristsensationexercise

Outcome Measures

Primary Outcomes (1)

  • Sensory Organization Test (SOT)

    Balance measurement

    14 weeks

Study Arms (2)

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.

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.

Other: Multi-Sensory Training

Interventions

Also known as: Wrist Stabilisation Training
Multi-Sensory Training (MST)Wrist Stabilisation Training (WT)

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Multisystem atrophy
  • Motor neuron disease
  • Dementia, decline of cognitive function
  • Serious mental illness
  • Amputation in lower limbs
  • Epilepsy on medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iceland

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Fractures, BoneMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Study Officials

  • Palmi V Jonsson, MD

    Landspitali National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 27, 2018

Study Start

May 15, 2015

Primary Completion

May 25, 2016

Study Completion

May 25, 2016

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations