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Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06130865
Enrollment
104
Registered
2023-11-14
Start date
2023-11-05
Completion date
2024-05-10
Last updated
2023-11-14

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

Conditions

Peripheral Neuropathy

Keywords

Balance., Diabetes, Diabetic Peripheral Neuropathy, Otago Exercise Plan

Brief summary

Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the patients of diabetic peripheral neuropathy.

Detailed description

Diabetes is a serious, long-term condition with a major impact on the lives and well-being of individuals, families, and societies worldwide. Diabetic neuropathy is its most common clinical consequence. Diabetic Peripheral Neuropathy (DPN) is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes. A person with DPN is up to 20 times more likely to fall than a non-diabetic of the same age, making falls an even more significant therapeutic concern. As a result of decreased balance, people with DPN are predisposed to falls, which can lead to injury, decreased balance confidence, fear-related avoidance of activities, and decreased quality of life. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the population of DPN and it will also predict which of them is the most responsive and sensitive and first evaluates changes in balance of patients with DPN. After the comparison of responsiveness and sensitivity of these scales, it can predict the best tool for early assessment of balance impairment in the people with DPN. This study will be beneficial in early identification of fall risk and minimization of fall related injuries and complications.

Interventions

None listed

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Either gender. * Age between 40 to 60 years * Known history of diabetes mellitus treated with by oral hypoglycemic drugs or insulin therapy. * Known case of diabetic peripheral neuropathy (DPN) * Patients who met the criteria of DN4 scored equal or greater than 4. * Patients who have positive SHARPEND ROMBERG TEST. * Balance impairment on BBS (21-40).

Exclusion criteria

* Lower limb muscles strength less than 3 on manual muscle testing. * Any inflammatory condition, congenital or acquired malformation, vestibular system pathologies. * Contraindication for engaging in physical activity (osteoarthritis, orthostatic hypo tension or any acute illness).

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance Scale8 WeeksA clinical tool that assesses static and dynamic balance.
Mini Balance Evaluation Systems Test (mini-BESTest)8 weeksA clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.
Fullerton Advanced Balance Scale (FAB)8 weeksThe FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026