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Clinical Trials/NCT06130865
NCT06130865
Not yet recruiting
Not Applicable

Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Riphah International University1 site in 1 country104 target enrollmentNovember 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Neuropathy
Sponsor
Riphah International University
Enrollment
104
Locations
1
Primary Endpoint
Mini Balance Evaluation Systems Test (mini-BESTest)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2023
End Date
May 10, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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).

Outcomes

Primary Outcomes

Mini Balance Evaluation Systems Test (mini-BESTest)

Time Frame: 8 weeks

A 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)

Time Frame: 8 weeks

The FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.

Berg Balance Scale

Time Frame: 8 Weeks

A clinical tool that assesses static and dynamic balance.

Study Sites (1)

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