Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

NCT06130865 | Unknown DMC

• 1 other identifier: REC/0246 Faria Ali Shahid
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Berg Balance Scale

  A clinical tool that assesses static and dynamic balance.

  8 Weeks

• 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

• 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

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

The Irus Clinic and Rehabilitation Center

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• aruba saeed, PHD

  Riphah International University Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 5, 2023
• Primary Completion: April 10, 2024
• Study Completion: May 10, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)