Tai Chi vs. Modified-Otago Exercises for Pain, Balance, and Motor Function in Diabetic Peripheral Neuropathy

NCT07078565 | Recruiting DMC

• 1 other identifier: REC/RCR & AHS/24/0295
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

his randomized clinical trial evaluates the comparative effectiveness of Tai Chi and Modified-Otago exercise programs on pain reduction, balance improvement, and motor function in patients diagnosed with diabetic peripheral neuropathy (DPN). DPN is a common complication of Type 2 Diabetes Mellitus that significantly impairs quality of life through chronic pain, balance deficits, and decreased functional mobility. While pharmacological treatments are commonly used, they often result in adverse side effects, creating a growing need for non-pharmacological interventions like therapeutic exercises. Tai Chi, a traditional Chinese exercise combining slow movements and mental focus, has shown benefits in improving mobility and reducing fall risks in chronic disease populations. The Modified-Otago program, originally developed to prevent falls in the elderly, emphasizes strength and balance training through structured exercise routines. A total of 36 participants (aged 40-80 years) with at least a 5-year history of Type 2 diabetes and a minimum pain score of ≥3 on the Numeric Pain Rating Scale (NPRS) will be recruited. Participants will be randomly allocated to either the Tai Chi group or the Modified-Otago group. Both groups will receive 24 sessions over an 8-week period (3 sessions per week), along with baseline interventions such as heating pad application, TENS, and warm-up/cool-down routines. Primary outcome measures include NPRS for pain, the Berg Balance Scale (BBS) for balance, and the Dynamic Gait Index (DGI) for motor function. Assessments will be conducted at baseline, post-intervention, and two weeks post-treatment. Data will be analyzed using SPSS version 26 to determine within-group and between-group differences. This study aims to inform clinicians about effective exercise strategies for improving physical function in patients with DPN and potentially establish evidence-based rehabilitation protocols.

Conditions

Diabetic Peripheral Neuropathy (DPN); Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetic Peripheral Neuropathy; Tai Chi; Modified-Otago Exercises; Balance Training

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), which rates pain on a scale from 0 (no pain) to 10 (worst imaginable pain).

  4 weeks

Secondary Outcomes (2)

• Balance

  4 weeks

• Gait Performance

  4 weeks

Study Arms (2)

Tai Chi

EXPERIMENTAL

Participants in this group will receive Tai Chi-based therapeutic exercise sessions, including joint mobility, balance, flexibility, and strength training movements (e.g., Qigong and bow stance).

Other: Tai Chi

Modified-Otago Exercises

EXPERIMENTAL

Participants in this group will receive the Modified-Otago Exercise Program focused on strength and balance training through functional exercises like stair walking, knee bends, and toe raises.

Other: Modified-Otago Exercises

Interventions

Modified-Otago Exercises OTHER

Intervention is administered 3 times per week for 4 weeks, with the same baseline therapy as the Tai Chi group.

Modified-Otago Exercises

Tai Chi OTHER

Intervention is administered 3 times per week for 4 weeks, along with baseline therapy (TENS + heating pad).

Tai Chi

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders are aged 40-80 years
• Patient having Types ii diabetes with Minimum of 5 years since diabetes diagnosis
• Patients experiencing chronic pain for at least 6 months and level ≥ 3 on NPRS.
• Patient having ≥ 6 score on Toronto Clinical Neuropathy Scoring System for diabetic neuropathy

You may not qualify if:

• Non-ambulatory patients
• Patients with ulceration/infection of feet, medical/surgical conditions
• Patients suffering from stroke, parkinson's disease, or multiple sclerosis

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehab Training and Research Center,

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Amna Shahid, t-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: January 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)