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

NCT ID: NCT07078565

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-12-30

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.

Detailed Description

Diabetic Peripheral Neuropathy (DPN) is a chronic complication of diabetes characterized by pain, numbness, and impaired balance. It frequently leads to limitations in mobility and increased fall risk, significantly affecting patients' independence and quality of life. Standard treatments often include pharmacological agents, but their long-term use is associated with adverse effects. As a result, non-drug interventions like exercise are increasingly being promoted as safer and equally effective alternatives.

Tai Chi and Modified-Otago exercise programs have individually shown promise in populations with mobility impairments. Tai Chi integrates slow, controlled movements with breathing and mindfulness, making it suitable for elderly individuals or those with chronic conditions. The Modified-Otago program was specifically designed to prevent falls through strength and balance training. While both interventions are beneficial independently, no study has yet compared their relative efficacy in managing symptoms of DPN.

Conditions

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

Study Design

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

Study Groups

Tai Chi

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).

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: OTHER

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

Modified-Otago Exercises

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.

Group Type: EXPERIMENTAL

Modified-Otago Exercises

Intervention Type: OTHER

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

Interventions

Modified-Otago Exercises

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

Intervention Type: OTHER

Tai Chi

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amna Shahid, t-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah Rehab Training and Research Center,

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Facility Contacts

Dr. Ali Raza, MS-OMPT

Role: primary

araza.frahs@riphah.edu.pk

Nadeem Leo

Role: backup

03000722941

Other Identifiers

REC/RCR & AHS/24/0295

Identifier Type: -

Identifier Source: org_study_id