Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

NCT ID: NCT06130865

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-05-10

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.

Conditions

Peripheral Neuropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

aruba saeed, PHD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University Pakistan

Locations

The Irus Clinic and Rehabilitation Center

Multan, Punjab Province, Pakistan

Countries

Pakistan

Facility Contacts

Aruba Saeed, PHD

Role: primary

aruba.saeed@riphah.edu.pk

03344399403

Other Identifiers

REC/0246 Faria Ali Shahid

Identifier Type: -

Identifier Source: org_study_id