Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130865
• Other study ID #: REC/0246 Faria Ali Shahid
• Status: Not yet recruiting
• Start date: November 5, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: November 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: May 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Locations

Country	Name	City	State
Pakistan	The Irus Clinic and Rehabilitation Center	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	A clinical tool that assesses static and dynamic balance.	8 Weeks
Primary	Mini Balance Evaluation Systems Test (mini-BESTest)	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.	8 weeks
Primary	Fullerton Advanced Balance Scale (FAB)	The FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.	8 weeks