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

NCT ID: NCT07293507

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-04-30

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

Modified Otago Exercises

Group Type: EXPERIMENTAL

Modified Otago Exercises

Intervention Type: OTHER

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 B

Dynamic Neuromuscular Stabilization Exercises

Group Type: EXPERIMENTAL

Dynamic neuromuscular stabilization exercises

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sana Riaz, Nmpt

Role: PRINCIPAL_INVESTIGATOR

Locations

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

Sialkot, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Imran Amjad Amjad, PhD

Role: CONTACT

Phone: +92 324390125

Email: Imran.amjad@riphah.edu.pk

Facility Contacts

Sana Riaz, Nmpt

Role: primary

Other Identifiers

7424 ZUNAIRA SALEEM BUTT

Identifier Type: -

Identifier Source: org_study_id