NCT02436837

Brief Summary

Background: Taking into consideration the ongoing inversion of the population pyramid and the limitations and medical conditions, which predispose to episodes of falling among elderly people, the implementation of exercises and physical treatments capable of promoting postural balance in the group studied is made necessary. Objectives: Assess the influence of the electronic platform Kinect Sensor® (KS) as a tool in the treatment of postural balance in elderly individuals. Method: The study included 10 elderly (60 to 70 years old) and 10 young (20 to 30 years old) individuals. Treatment protocol composed of five weeks with sessions performed twice a week with application of KS. Initial and final evaluation included static and dynamic balance instruments: Berg Balance scale and Timed up and Go and Romberg Tandem tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

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

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

April 30, 2015

Last Update Submit

May 6, 2015

Conditions

BalanceElderly

Outcome Measures

Primary Outcomes (2)

  • anamnesis questionnaire for physical health condition

    Those considered incapable of performing activities involving maintenance of balance or belonging to the health risk group were excluded. Health risk was defined by criteria such as, cardiopathies, uncontrolled hypertension, auditory and visual impairment, neurological disturbances and severe muscle-skeletal conditions.

    one day

  • Berg Balance Scale for equilibrium condition

    Scores inferior to 45 points in the Berg Balance Scale also resulted in exclusion

    one day

Secondary Outcomes (3)

  • Berg Balance Scale for equilibrium condition

    five weeks

  • Timed Up and Go Test for the performance of physical agility

    five weeks

  • Romberg TandemTest for equilibrium performance

    five weeks

Study Arms (2)

young

ACTIVE COMPARATOR

20 to 30 years old individuals used as a comparator for elderly group

Other: sessions with virtual reality

elderly

EXPERIMENTAL

target of treatment to improve the balance.

Other: sessions with virtual reality

Interventions

sessions with virtual realityOTHER

sessions with virtual reality to improve the balance

elderlyyoung

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals have to be elderly (60 to 70 years old) or young (20 to 30 years old).

You may not qualify if:

  • anamnesis questionnaire: cardiopathies, uncontrolled hypertension, auditory and visual impairment, neurological disturbances and severe muscle-skeletal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Juiz de Fora

Juiz de Fora, Brazil

Location

Related Publications (5)

  • Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

    PMID: 1468055BACKGROUND

  • Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and laboratory measures of postural balance in an elderly population. Arch Phys Med Rehabil. 1992 Nov;73(11):1073-80.

    PMID: 1444775BACKGROUND

  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND

  • Diamantopoulos II, Clifford E, Birchall JP. Short-term learning effects of practice during the performance of the tandem Romberg test. Clin Otolaryngol Allied Sci. 2003 Aug;28(4):308-13. doi: 10.1046/j.1365-2273.2003.00710.x.

    PMID: 12871243BACKGROUND

  • Agrawal Y, Carey JP, Hoffman HJ, Sklare DA, Schubert MC. The modified Romberg Balance Test: normative data in U.S. adults. Otol Neurotol. 2011 Oct;32(8):1309-11. doi: 10.1097/MAO.0b013e31822e5bee.

    PMID: 21892121BACKGROUND

Study Officials

  • Andre GF Oliveira, PhD

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 7, 2015

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

BR(1)