- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293507
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
36
Phase
- 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
- Name: Imran Amjad Amjad, PhD
- Phone Number: +92 324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Sialkot, Punjab Province, Pakistan, 51310
- imran idrees teaching hospital daska Road sialkot, Dar ul shifa hospital sialkot
-
Contact:
- Sana Riaz, Nmpt
- Phone Number: +92 347 4716107
- Email: sana.rcrs@riphah.edu.pk
-
Principal Investigator:
- Zunaira Saleem Butt, Ms-NMPT
-
Sub-Investigator:
- Sana Riaz, Nmpt
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-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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
|
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
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
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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
Investigators
- 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)
December 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
December 8, 2025
First Submitted That Met QC Criteria
December 8, 2025
First Posted (Actual)
December 19, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 8, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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