MOE and DNSE Effects on Balance and Activities of Daily Living Diabetic Peripheral Neuropathy

December 8, 2025 updated by: Riphah International University

Effects of Modified Otago Exercises Versus Neuromuscular Dynamic Stabilization Exercises on Balance and Activities of Daily Living in Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to compare the impact of Modified Otago Exercises and Dynamic Neuromuscular Stabilization Exercises on patients with diabetic peripheral neuropathy (DPN) using valid tools such as the Berg Balance Scale and the Katz Index of Independence in ADL. The results of our study will be helpful for clinical decision-making in terms of selecting specific physiotherapy treatment techniques in an attempt to improve their function, reduce their falls, and improve their independence specific to diabetes neuropathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research into therapeutic exercise for patients with diabetic peripheral neuropathy (DPN) has grown over the past decade due to the increasing recognition of non-pharmacological strategies for reducing fall risk and restoring function. DPN is associated with altered gait, diminished proprioception, and increased postural sway, making balance-specific exercise programs a critical area of intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 51310
        • imran idrees teaching hospital daska Road sialkot, Dar ul shifa hospital sialkot
        • Contact:
        • Principal Investigator:
          • Zunaira Saleem Butt, Ms-NMPT
        • Sub-Investigator:
          • Sana Riaz, Nmpt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 60 years of age and elderly.
  • The Timed Up and Go score exceeds 10 seconds.
  • Both men and women
  • Individuals with type 2 diabetes and DPN.
  • Patients diagnosed with diabetes from last 5 Years.
  • Patients diagnosed with diabetic peripheral neuropathy with scores ≥ 4 on Michigan Neuropathy Screening Instrument (MNSI)
  • Individuals with an ability to walk independently.

Exclusion Criteria:

  • Individuals with neuropathies that are not caused by diabetes.
  • Individuals with any neurological disorders that may affect their ability to balance.
  • Participants suffering from any musculoskeletal disorders that result in discomfort and instability.
  • A history of acute and chronic physiological, psychological, and mental disorders that may prevent exercise.
  • Participants with unrelated orthopedics, surgical, or health conditions that impair physical movement and equilibrium, such as severe diabetic retinopathy were eliminated, as were those with active foot issues.
  • Patients having serious complications of diabetes, such as amputation and patients who are unable to complete the entire program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Modified Otago Exercises
Other: Modified Otago Exercises
The 30-minute Otago Exercise Program, involving both balance and strength training, followed by further 15 minutes of walking as part of the modified-OEP group intervention will be given. The 15-minute walk will be completed by walking continuously at an appropriate pace in the approximately 15-meter exercise room. Participants will be told to walk 15 meters, execute a U-turn to the left, walk 15 meters, and then execute a U-turn to the right at the next turning point to create the same effect on the stated benefit of symmetry while turning left and right. For twelve weeks, the intervention will be given three times a week.
Experimental: Group B
Dynamic Neuromuscular Stabilization Exercises
Other: Dynamic neuromuscular stabilization exercises
The Dynamic neuromuscular stabilization exercises (DNS) twice a week for 60 minutes each time for 12 weeks. A five-minute warm-up, a fifty-minute exercise plan, and a five-minute cool-down comprised the program. Static stretching was used for the cool-down and dynamic stretching for the warm-up. DNS training is conducted in three levels. Level 1 (1 to 4 weeks) includes: (1) dynamic stretching (2) baby rock (3) breathing (4) rolling. Level 2 (5 to 8 weeks) includes: (1) oblique sit (2) aqua bag tripod (3) aqua bag sitting (4) aqua bag kneeling. Level 3 (9 to 12 weeks) include: (1) aqua bag high kneeling (2) static stretching (3) aqua bag standing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Katz Index of Independence in Activities of Daily Living
Time Frame: Baseline, after 6th week, after 12th week
The Katz Index of Independence in Activities of Daily Living (ADL) is a tool that assesses a person's ability to perform six basic self-care tasks: bathing, dressing, toileting, transferring, continence, and feeding
Baseline, after 6th week, after 12th week
Berg Balance Scale
Time Frame: Baseline, After 6th week, After 12th week
The Berg Balance Scale (BBS) is a 14-item test that assesses an individual's static and dynamic balance through a series of tasks, such as sitting to standing, reaching, and turning.
Baseline, After 6th week, After 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sana Riaz, Nmpt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7424 ZUNAIRA SALEEM BUTT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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