CClinicalTrials.gg
Not yet recruitingNCT06130865Updated Nov 14, 2023

Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

An observational study in Peripheral Neuropathy, sponsored by Riphah International University. Not yet recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Riphah International University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripheral Neuropathy

Keywords

  • Balance.
  • Diabetes
  • Diabetic Peripheral Neuropathy
  • Otago Exercise Plan
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's planned enrollment of 104 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Berg Balance Scale

    A clinical tool that assesses static and dynamic balance.

    Time frame: 8 Weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • The Irus Clinic and Rehabilitation Center
    Multan, Punjab 60000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06130865
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
Nov 5, 2023 (estimated)
Primary completion
Apr 10, 2024 (estimated)
Completion
May 10, 2024 (estimated)
Last update
Nov 14, 2023

Study contacts

aruba saeed, PHD
principal investigator · Riphah International University Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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