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Virtual Reality in diabetic elderly

Influence of a Virtual Reality protocol on body balance of elderly with Mellitus Diabetes type 2: controlled randomized clinical test

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-67y6cz
Enrollment
Unknown
Registered
2019-10-14
Start date
2019-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

A total of 34 elderly will undergo the initial assessment, containing Clinical characterization, cognition (MMSE), body balance (MINI BESTest) as the dependent variable, functional mobility (SPPB), ca
hand grip strength (TFPP), difficulty performing daily activities (BOMFAQ)
and depressive symptoms (GDS). This initial moment will happen through previous randomization so that these elderly are divided into 2 distinct groups, identified by Control Group (17 individuals) and
Other
L01.224.160.875
E02.760.169.063.500
G11.427.690

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Hospital Universitário Onofre Lopes
Collaborator

Eligibility

Age
65 Years to 79 Years

Inclusion criteria

Inclusion criteria: Will be included in the study individuals aged between 65 and 79 years; have a clinical diagnosis of type 2 diabetes mellitus according to the criteria of the American Diabetes Association - ADA (GROSS et al., 2002); presenting complaints of altered body balance, defined as imbalance and / or dizziness (BITTAR, BOTTINO, BENTO, 2003); have a higher risk of falls by the Dynamic Gait Index with a score of 19 or less (SHUMWAY-COOK, WOOLACOTT, 1995); do not present cognitive impairment according to education (BRUCKI et al., 2003); have mild or moderate peripheral neuropathy assessed by the Neuropathic Symptom Score - ESN (MOREIRA et al., 2005); have good visual acuity assessed by the Snellen Table (JANUZZI et al., 2014); are not undergoing some kind of body balance rehabilitation or performed it up to six months before the survey.

Exclusion criteria

Exclusion criteria: (1) Individuals undergoing balance rehabilitation currently or in the past six months; (2) clinical diagnosis of carpal tunnel syndrome.

Design outcomes

Primary

MeasureTime frame
At least 5% greater improvement in postural balance is expected in the virtual reality treated group than in the kinesiotherapy group, all measured by the Mini - The Balance Evaluation Systems Test (Mini BESTest). For this, the 2x2 repeated measures ANOVA will be used considering as an intergroup factor, the intervention and control groups; and the intragroups, the two evaluations to be performed. The effect size (F) and 95% confidence interval (CI) will be displayed and the significance level of 5% (p<0,05) will be adopted.

Secondary

MeasureTime frame
Secondary outcome 1 is expected to correlate DM2 comorbidities with the clinical characteristics of the elderly. To correlate DM2 comorbidities (categories) with clinical characteristics (categories and quantitative), the chi-square test or Pearson or Spearman correlations (depending on the normality of the data) will be used and statistical significance is sought (p<0,05).;Secondary outcome 2 is expected to improve cognition by at least 1% by Mini Mental State Examination after each protocol application and follow-up. For this, the paired T test or Wilcoxon test will be used, depending on the normality of the data. Statistical significance is expected (p<0,05).;Secondary outcome 3 is expected to have at least a 1% improvement in functional mobility measured by the Short Physical Performance Battery after application of each protocol and follow-up. For this, the paired T test or Wilcoxon test will be used, depending on the normality of the data. Statistical significance is expected (p<0,05).;Secondary outcome 4 is expected to have at least a 1% improvement in depressive symptoms as measured by the Geriatric Depression Scale (GDS) after application of each protocol and follow-up. For this, the paired T test or Wilcoxon test will be used, depending on the normality of the data. Statistical significance is expected (p<0,05).

Countries

Brazil

Contacts

Public ContactBartolomeu Lima Filho

Universidade Federal do Rio Grande do Norte

bartolomeu_fagundes2@hotmail.com+55-84-994197593

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 15, 2026