NCT07078565 Tai Chi vs. Modified-Otago Exercises for Pain, Balance, and Motor Function in Diabetic Peripheral Neuropathy
| NCT ID | NCT07078565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riphah International University |
| Condition | Diabetic Peripheral Neuropathy (DPN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-01-25 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-01-25 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Amna Shahid, t-DPT
PRINCIPAL INVESTIGATOR
Riphah International University
Frequently Asked Questions
Who can join the NCT07078565 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Diabetic Peripheral Neuropathy (DPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07078565 currently recruiting?
Yes, NCT07078565 is actively recruiting participants. Contact the research team at imran.amjad@riphah.edu.pk for enrollment information.
Where is the NCT07078565 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07078565 clinical trial?
NCT07078565 is sponsored by Riphah International University. The principal investigator is Amna Shahid, t-DPT at Riphah International University. The trial plans to enroll 36 participants.