NCT07293507

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 8, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Diabetes Mellitus Diabetic Peripheral Neuropathy Modified Otago Exercise Dynamic Neuromuscular Stabilization Berg Balance Scale Balance Training.

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Baseline, After 6th week, After 12th week

Study Arms (2)

Group A

EXPERIMENTAL

Modified Otago Exercises

Other: Modified Otago Exercises

Group B

EXPERIMENTAL

Dynamic Neuromuscular Stabilization Exercises

Other: Dynamic neuromuscular stabilization exercises

Interventions

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

Group B

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.

Group A

Eligibility Criteria

Age60 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

imran idrees teaching hospital daska Road sialkot, Dar ul shifa hospital sialkot

Sialkot, Punjab Province, 51310, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sana Riaz, Nmpt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad Amjad, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

December 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations