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NCT Number: NCT07078565

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy (DPN) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus (T2DM)

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehab Training and Research Center,

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Arshia Ijaz, DPT

PRINCIPAL_INVESTIGATOR

Dr. Ali Raza, MS-OMPT

CONTACT

[email protected]

Nadeem Leo

CONTACT

03000722941

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified-Otago Exercises

Other

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

Tai Chi

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. Balance

    Time frame: 4 weeks

    Balance will be assessed using the Berg Balance Scale (BBS), a 14-item scale that evaluates static and dynamic balance in older adults.

  2. Gait Performance

    Time frame: 4 weeks

    Motor function and dynamic walking ability will be measured using the Dynamic Gait Index (DGI), which assesses an individual's ability to modify gait in response to changing task demands.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Tai Chi Versus Modified-Otago Exercises On Pain, Balance And Motor Function In Patients With Diabetic Peripheral Neuropathy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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