Multi-Sensory Training and Wrist Fractures

• ClinicalTrials.gov Identifier: NCT03478228
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Sponsor: Landspitali University Hospital
• Information provided by (Responsible Party): Landspitali University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postural Balance	Other: Multi-Sensory Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Balance Among People With Fall-related Wrist Fractures and Effects of Sensory Training
• Actual Study Start Date: May 15, 2015
• Actual Primary Completion Date: May 25, 2016
• Actual Study Completion Date: May 25, 2016

Arms and Interventions

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 Name: 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 Name: Wrist Stabilisation Training

Outcome Measures

Primary Outcome Measures :

1. Sensory Organization Test (SOT) [ Time Frame: 14 weeks ]
   Balance measurement

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Iceland

University of Iceland

Reykjavik, Iceland, 101

Sponsors and Collaborators

Landspitali University Hospital

Investigators

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

More Information

• Responsible Party: Landspitali University Hospital
• ClinicalTrials.gov Identifier: NCT03478228
• Other Study ID Numbers: 2013 16 ÓB/eí
• First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Landspitali University Hospital:

fracture; rehabilitation; wrist; sensation; exercise

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries