Diabetic Peripheral Neuropathy (DPN)NCT07078565
Tai Chi vs. Modified-Otago Exercises for Pain, Balance, and Motor Function in Diabetic Peripheral Neuropathy
A study testing Modified-Otago Exercises and Tai Chi in people with Diabetic Peripheral Neuropathy (DPN) and Type 2 Diabetes Mellitus (T2DM), run by Riphah International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN), Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Modified-Otago Exercises and Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-ambulatory patients
- Patients with ulceration/infection of feet, medical/surgical conditions
- Patients suffering from stroke, parkinson's disease, or multiple sclerosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah Rehab Training and Research Center,
Lahore, Punjab Province, 54000
Dr. Ali Raza, MS-OMPT, araza.frahs@riphah.edu.pk
Nadeem Leo, 03000722941
About this study
Official title: Comparative Effects of Tai Chi Versus Modified-Otago Exercises On Pain, Balance And Motor Function In Patients With 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.
Read more
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.
Read the 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.
- Being tested
- Modified-Otago Exercises, Tai Chi
- Keywords
- Diabetic Peripheral Neuropathy, Tai Chi, Modified-Otago Exercises, Balance Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified-Otago ExercisesOther
Intervention is administered 3 times per week for 4 weeks, with the same baseline therapy as the Tai Chi group.
Tai ChiOther
Intervention is administered 3 times per week for 4 weeks, along with baseline therapy (TENS + heating pad).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Modified-Otago Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (2)
Balance
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item scale that evaluates static and dynamic balance in older adults.
Measured: 4 weeks
Gait Performance
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jan 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amna Shahid, t-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078565
- Sponsor's protocol ID
- REC/RCR & AHS/24/0295
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to institutional policies, ethical considerations, and privacy concerns. All data will be kept confidential and used solely for the purposes of this stud
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Tai Chi Versus Modified-Otago Exercises On Pain, Balance And Motor Function In Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07078565
- Acronym / sponsor ID
- REC/RCR & AHS/24/0295
- Keywords
- Diabetic Peripheral Neuropathy, Tai Chi, Modified-Otago Exercises, Balance Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Other: Tai ChiParticipants 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). |
| Modified-Otago Exercises | Experimental | Other: Modified-Otago ExercisesParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Non-ambulatory patients
- Patients with ulceration/infection of feet, medical/surgical conditions
- Patients suffering from stroke, parkinson's disease, or multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified-Otago ExercisesIntervention is administered 3 times per week for 4 weeks, with the same baseline therapy as the Tai Chi group. | Other | Modified-Otago Exercises |
| Tai ChiIntervention is administered 3 times per week for 4 weeks, along with baseline therapy (TENS + heating pad). | Other | Tai Chi |
Primary outcome
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).
2 secondary outcomes
Balance
Time frame: 4 weeks
Gait Performance
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to institutional policies, ethical considerations, and privacy concerns. All data will be kept confidential and used solely for the purposes of this stud
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amna Shahid, t-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified-Otago Exercises and Tai Chi in people with Diabetic Peripheral Neuropathy (DPN) and Type 2 Diabetes Mellitus (T2DM), run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.