NCT04036383

Brief Summary

The aim of this study to examine the effectiveness of different types of exercise trainings on functionality in older faller

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

July 12, 2019

Last Update Submit

January 14, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Balance Function Assessment-Sensory Organization Test

    Sensory Organization Test (SOT): This is a six-part test that objectively identifies abnormalities in somatosensory, visual, and vestibular systems that provide postural control. The result is a ratio between 0-100 and 100 means perfect stability.

    5 minutes

  • Cognitive Function assessment

    Cognitive function will be assessed with "Montreal Cognitive Assessment Scale(MoCA)"The MoCA is a screening instrument that evaluates cognitive domains on a single page and scores range from 0 to 30."0" points indicate poor cognitive functions, "30" points indicate good cognitive functions. Increase in scores indicates better cognitive functions.

    10 minutes

  • Gait Function assessment

    Dynamic Gait Index will be used to evaluate the adaptations during the patient's gait. It evaluates activities such as slow walking, fast walking, walking with head movements, turning, stepping up, jumping obstacles, 0 points are weak and 3 points are successful. Low scores from the scale are indicative of disorders that may cause falls.A total of 8 parameters are evaluated over 24 points.

    15 minutes

  • Balance Function Assessment- Adaptation Test

    Adaptation Test (ADT):This test evaluates the patient's response to sudden changes and irregularities in the ground and the ability to reduce oscillations. The oscillation energy score is obtained by measuring the force applied to the force platform for recovery. Scores between 0 and 200.Since the maximum score given by the device is 200, the score of that test is considered as 200 in case of a fall. The oscillation energy score is close to 0, indicating better postural adaptation.

    5 minutes

Study Arms (3)

vestibüler

ACTIVE COMPARATOR

vestibular exercise training

Other: vestibular exercise trainingOther: Balance training with computerized balance systemOther: square step exercises

balance training

EXPERIMENTAL

vestibular exercise training+ balance training with computerized balance system

Other: vestibular exercise trainingOther: Balance training with computerized balance systemOther: square step exercises

square-step

EXPERIMENTAL

vestibular exercise training+ square step exercise

Other: vestibular exercise trainingOther: Balance training with computerized balance systemOther: square step exercises

Interventions

The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises

balance trainingsquare-stepvestibüler

Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided. Qualitative information reflects progression during static and dynamic postural exercises of the patient. To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises. The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.

balance trainingsquare-stepvestibüler

Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts. Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty. The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.

balance trainingsquare-stepvestibüler

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older individuals,
  • Mini Mental State Examination Test score above 24,
  • At least two falls in the last year
  • Independent individuals in mobilization without walking aid

You may not qualify if:

  • Cardiac diseases
  • Pulmonary embolism and deep vein thrombosis in the last three months,
  • A history of cerebral aneurysm or intracranial hemorrhage,
  • Acute retinal hemorrhage or previous ophthalmic surgery,
  • Active infection,
  • Multiple organ failure,
  • Terminal disease status,
  • A history of fractures in the lower and upper extremities within the last three months,
  • Severe hearing and vision loss,
  • Patients with Alzheimer's disease, Parkinson's disease, dementia
  • Patients diagnosed with Benign Paroxysmal Positional Vertigo,
  • Those who have received exercise training in the last 6 months,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (5)

  • Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.

    PMID: 23467506BACKGROUND
  • Shigematsu R, Okura T, Nakagaichi M, Tanaka K, Sakai T, Kitazumi S, Rantanen T. Square-stepping exercise and fall risk factors in older adults: a single-blind, randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):76-82. doi: 10.1093/gerona/63.1.76.

    PMID: 18245764BACKGROUND
  • Shigematsu R, Okura T, Sakai T, Rantanen T. Square-stepping exercise versus strength and balance training for fall risk factors. Aging Clin Exp Res. 2008 Feb;20(1):19-24. doi: 10.1007/BF03324743.

    PMID: 18283224BACKGROUND
  • Fisseha B, Janakiraman B, Yitayeh A, Ravichandran H. Effect of square stepping exercise for older adults to prevent fall and injury related to fall: systematic review and meta-analysis of current evidences. J Exerc Rehabil. 2017 Feb 28;13(1):23-29. doi: 10.12965/jer.1734924.462. eCollection 2017 Feb.

    PMID: 28349029BACKGROUND
  • Moreira Bittar RS, Simoceli L, Bovino Pedalini ME, Bottino MA. The treatment of diseases related to balance disorders in the elderly and the effectiveness of vestibular rehabilitation. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):295-8. doi: 10.1016/s1808-8694(15)30071-9.

    PMID: 17684648BACKGROUND

Study Officials

  • Ayşe ABİT KOCAMAN

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 29, 2019

Study Start

December 31, 2018

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations