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BalanceAKSNCT02436837

Applicability of Kinect Sensor® in the Rehabilitation of Balance in the Elderly

A study testing sessions with virtual reality in people with Balance and Elderly, run by Federal University of Juiz de Fora at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Balance, Elderly
What is being tested?
sessions with virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
Jan 2013to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • anamnesis questionnaire: cardiopathies, uncontrolled hypertension, auditory and visual impairment, neurological disturbances and severe muscle-skeletal conditions.
  • cores inferior to 45 points in the Berg Balance Scale also resulted in exclusion.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Federal University of Juiz de Fora

    Juiz de Fora

Other trials in Brazil

About this study

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.

Read more

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.

Read the detailed description

Sample Each volunteer has agreed to participate of this research after signing a informed consent. The present work has been approved by the Ethics Committee of Research of the School of Medical and Health Sciences of Juiz de Fora, SUPREMA University, Juiz de Fora, Brazil, under the statement 0015/12.

Each subject filled adequately an anamnesis questionnaire composed of items which referred to the inclusion and exclusion criteria. 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. Besides those factors, scores inferior to 45 points in the Berg Balance Scale also resulted in exclusion.

In order to collect data, 26 individuals from the Hospital and Maternity Ward Therezinha de Jesus (School of Medical and Health Sciences of Juiz de Fora, SUPREMA University, Juiz de Fora, Brazil) were evaluated. Among them, six have been excluded for distinct reasons, such as, abandoning the proposed sessions or presenting risk factors inserted in the exclusion criteria of the study. The experimental group was composed by 10 subjects (eight females) with mean age of 64.5 years old and the control group had other 10 participants (five females) with mean age 23 years.

The sampled individuals were subject to a sequence of tests specifically devised for static and dynamic balance, which could be used as a comparison parameter for postural balance among the individuals. The tests applied were: a) Timed Up and Go test (TUG); b) Romberg Tandem test; c) Berg Balance scale.

Protocol Treatment protocol consisted of 10 sessions with maximal length of 6 minutes for performing activities using the KS. The interval between the evaluations was of five weeks and the sessions took place twice times a week, according to the participant availability. Before the first session and one day preceding the last, the individuals were evaluated in what concerns static and dynamic balance. Arterial pressure (AP) measurement and stretching activity were performed prior to the KS session. Afterwards, AP was again measured.

Berg Balance Scale Berg Balance scale was the main instrument in the assessment of the postural balance, which was also used as exclusion criterion. It is used in the clinical practice, mainly for the elderly population or neurologic disturbed patients, who have been referred to rehabilitation. The test is constituted of 14 ordinary static and dynamic balance tasks, which are related to quotidian life activities, such as getting up, transfer oneself, standing up, reaching for an object and turning. Each task generates a score between zero and four points, so that the total may be of 56 points. Points are subtracted from the total of a task, if the subject needs aid or external support device to accomplish the particular task. According to Berg et al., patient scoring less or equal to 45 are at high risk of falling during ambulation, what justify the exclusion of volunteers to whom was attributed an inferior score aforementioned.

Timed Up and Go Test In order to perform the Timed Up and Go test (TUG), the subject would rise from a chair, walk three meters and return to the chair. The speed of task execution was established by the participant, with no stimulation by use of verbal commands. The time of execution was measured on the initial evaluation and one day past the tenth session.

Romberg TandemTest According to the protocol established by the Romberg Tandem test, the participants remained with the eyes closed in orthostatic position, with the calcaneus bone of the non-dominant foot placed ahead of the toes of the dominant foot, until the loose balance or reach 60 seconds, maximal time.

Arterial Pressure Arterial pressure (AP) was measured before and after each session. Individuals presenting hypertension stage 3 (≥ 180 systolic and ≥ 110 diastolic), which poses a threat to their practicing of physical activity, were withdrawn of the treatment.

Stretching After AP measurement, all subjects were instructed to perform muscular stretching exercises. The activities were performed in an active and assisted fashion, bilaterally, such as lateral cervical flexion, anterior and posterior inclination of the cervical column, orthostatic torso flexion, torso lateral inclination and rotation on the transverse plane. With the upper limbs, the motions proposed were flexion of shoulder and elbow, horizontal adduction of shoulders and flexion and extension of fingers and wrists. The participants also performed global exercises, cross walks, touching the knees with the hands alternately.

Kinect Sensor All the individuals, including the ones placed in the control group, were instructed on the execution of the activities and accompanied through verbal commands. They were positioned in front of the KS with the highest level of Stack em Up mode (available under the title Yourshape: Fitness Evolved®), and should keep static position with upper limbs raised, simulating sustain a platform. Colored boxes fall upon the simulated platform and must be deposited with the lateral inclination of the torso towards left or right, according to visual stimulus from the television, where virtual apertures are opened on alternate sides at the bottom of the screen. Eventually, fiery boxes fall, and it is necessary to raise the inferior limb of the side where the box is falling towards the platform in order to extinguish the fire, thus flexing knee and pelvic region at 90º.

Statistic Analysis D'agostino \& Pearson test was applied to verify the normality of the data. The mean analysis was done by paired Student's t-test for parametric data and Wilcoxon test for non-parametric for the data of each group; unpaired Student's t-test was performed for parametric data and Mann Whitney test for non-parametric data between the evaluated groups.

Conditions
Balance, Elderly
Being tested
sessions with virtual reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sessions with virtual realityOther

    sessions with virtual reality to improve the balance

Study groups in NCT02436837
Study groupRoleWhat they receive
youngActive comparator20 to 30 years old individuals used as a comparator for elderly group
Receives: Other: sessions with virtual reality
elderlyExperimentaltarget of treatment to improve the balance.
Receives: Other: sessions with virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one day

  2. Berg Balance Scale for equilibrium condition

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

    Measured: one day

Secondary outcomes (3)
  1. Berg Balance Scale for equilibrium condition

    Berg Balance scale was the main instrument in the assessment of the postural balance

    Measured: five weeks

  2. Timed Up and Go Test for the performance of physical agility

    In order to perform the Timed Up and Go test (TUG), the subject would rise from a chair, walk three meters and return to the chair. The speed of task execution was established by the participant, with no stimulation by use of verbal commands. The time of execution was measured on the initial evaluation and one day past the tenth session.

    Measured: five weeks

  3. Romberg TandemTest for equilibrium performance

    According to the protocol established by the Romberg Tandem test, the participants remained with the eyes closed in orthostatic position, with the calcaneus bone of the non-dominant foot placed ahead of the toes of the dominant foot, until the loose balance or reach 60 seconds, maximal time

    Measured: five weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436837
Sponsor's protocol ID
UFJFGV0001
Acronym
AKS
Status last verified
May 2015
First submitted
30 Apr 2015
Last updated
7 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 1468055
  • 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.

    PubMed 1444775
  • 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.

    PubMed 1991946
  • 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.

    PubMed 12871243
  • 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.

    PubMed 21892121

Questions about this trial

What is this clinical trial studying?

A study testing sessions with virtual reality in people with Balance and Elderly, run by Federal University of Juiz de Fora at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

anamnesis questionnaire for physical health condition (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02436837, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.

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