Diabetes Mellitus Type 2NCT07293507
MOE and DNSE Effects on Balance and Activities of Daily Living Diabetic Peripheral Neuropathy
A study testing Modified Otago Exercises and Dynamic neuromuscular stabilization exercises in people with Diabetes Mellitus Type 2, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Modified Otago Exercises and Dynamic neuromuscular stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
imran idrees teaching hospital daska Road sialkot, Dar ul shifa hospital sialkot
Sialkot, Punjab Province, 51310
Sana Riaz, Nmpt, +92 347 4716107, sana.rcrs@riphah.edu.pk
Zunaira Saleem Butt, Ms-NMPT
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Modified Otago Exercises, Dynamic neuromuscular stabilization exercises
- Keywords
- Diabetes Mellitus Diabetic Peripheral Neuropathy Modified Otago Exercise Dynamic Neuromuscular Stabilization Berg Balance Scale Balance Training.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Otago ExercisesOther
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.
Dynamic neuromuscular stabilization exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Modified Otago Exercises Receives: Other: Modified Otago Exercises |
| Group B | Experimental | Dynamic Neuromuscular Stabilization Exercises Receives: Other: Dynamic neuromuscular stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Katz Index of Independence in Activities of Daily Living
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
Measured: Baseline, after 6th week, after 12th week
Berg Balance Scale
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.
Measured: Baseline, After 6th week, After 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Riaz, Nmpt, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293507
- Sponsor's protocol ID
- 7424 ZUNAIRA SALEEM BUTT
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Otago Exercises Versus Neuromuscular Dynamic Stabilization Exercises on Balance and Activities of Daily Living in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07293507
- Acronym / sponsor ID
- 7424 ZUNAIRA SALEEM BUTT
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus Diabetic Peripheral Neuropathy Modified Otago Exercise Dynamic Neuromuscular Stabilization Berg Balance Scale Balance Training.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Modified Otago ExercisesModified Otago Exercises |
| Group B | Experimental | Other: Dynamic neuromuscular stabilization exercisesDynamic Neuromuscular Stabilization Exercises |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Otago ExercisesThe 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. | Other | Group A |
| Dynamic neuromuscular stabilization exercisesThe 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 | Other | Group B |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sana Riaz, Nmpt principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Otago Exercises and Dynamic neuromuscular stabilization exercises in people with Diabetes Mellitus Type 2, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad Amjad, PhD (+92 324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Katz Index of Independence in Activities of Daily Living (time frame: Baseline, after 6th week, after 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.