Clinical trial NCT06130865: Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy
Official title: Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Neuropathy
Keywords: Balance.
Diabetes
Diabetic Peripheral Neuropathy
Otago Exercise Plan
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Design:

The study design is a prospective cohort study, where a group of participants will be followed over time to observe changes in patient outcomes after receiving physiotherapy interventions.

Study Setting:

Data for this study will be collected from the Irus Clinic and Rehabilitation Center Multan

Study Duration:

The study will span a period of six months, commencing after receiving approval from the Bioethical Review Board (BASR).

Sample Size:

The study will include a total of 104 participants.

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.

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).

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 8 Weeks
measure: Mini Balance Evaluation Systems Test (mini-BESTest)
timeFrame: 8 weeks
measure: Fullerton Advanced Balance Scale (FAB)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: The Irus Clinic and Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University Pakistan
name: aruba saeed, PHD
role: PRINCIPAL_INVESTIGATOR
References: