Diabetic PolyneuropathyNCT07248631
Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking in Patients With Diabetic Polyneuropathy
A study testing Foot-Ankle therapeutic exercises and Mindful Walking. in people with Diabetic Polyneuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 40 to 75 months
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Foot-Ankle therapeutic exercises and Mindful Walking.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Oct 2024to 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 75 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with diabetic polyneuropathy (DPN) confirmed by medical history and clinical examination.
- Experience pain and disability in foot/ankle, with a Numeric Pain Rating Scale (NPRS) score ≥ 4.
- Independent walking ability for at least 10 m.
- Age (40-75) years.
- Ability to understand and follow exercise instructions.
- A maximum of one amputated toe, not being the hallux.
- Willingness to participate in the study and provide informed consent.
Who cannot join
- Presence of an active plantar ulcer or gangrene.
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period.
- Arthroplasty and/or orthosis of lower limbs or indication of lower limb arthroplasty throughout the intervention period.
- Participating in other exercise programs or studies.
- Dementia or inability to give consistent information.
- Diagnosis of neurological diseases.
- Neuropathic pain due to other causes (e.g., HIV, chemotherapy).
- Major vascular complications and/or severe retinopathy.
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
Nishtar 2
Multan, Punjab Province, 60000
Fatima Tariq, MS-NMPT, +923344255033, fatima.tariq@rihah.edu.pk
Ayesha Ahsan Kamal, MS-NMPT
About this study
Official title: Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking on Pain, Foot and Ankle Disability and Quality of Life in Patients With Diabetic Polyneuropathy
The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. This study seeks to evaluate the efficacy of these interventions in improving clinical outcomes and enhancing the overall well-being of individuals with diabetic polyneuropathy.
Read the detailed description
A 12-week foot-ankle therapeutic exercise program has been found to show positive effects compared to usual care on fast-gait speed, foot-ankle range of motion, vibration sensitivity, and quality of life in people with diabetic neuropathy.
Mindful walking's efficacy for chronic low back pain management has been investigated, with a randomized controlled trial of 55 patients yielding no significant improvements in pain intensity, back function, or stress after 8 weeks.
Exercise therapy has been found to significantly improve gait function in patients with diabetic peripheral neuropathy. A systematic review of 9 randomized controlled trials (370 participants) showed that exercise therapy enhances 6-minute walk test, 10-meter walk test, and Tinetti scale outcomes, improving mobility and reducing fall risk.
Exercise shows therapeutic potential for sensory nerve disorders, improving symptoms in most cases. Benefits are seen in diabetic pain and nerve damage, with varying mechanisms underlying these effects. Exercise therapy enhances outcomes for various nerve-related disorders, improving symptoms by at least two times compared to no exercise.
A 12-week study found significant improvements in glycemic control and vascular function in patients with type 2 diabetes who practiced Buddhist walking meditation, whereas traditional walking only improved blood glucose levels and cardiovascular fitness.
A study on sensor-based interactive balance training with visual joint movement feedback found significant improvements in postural stability in patients with diabetic peripheral neuropathy. The intervention group demonstrated a 62.68% reduction in CoM sway with eyes closed.
Physical therapy has been shown to impact limited joint mobility in diabetic neuropathy patients. A study found significant joint mobility improvements after 10 sessions of passive joint mobilization, with near-normal mobility achieved after 20 sessions.
A 4-week multimodal treatment program (treadmill, muscle strengthening, balance training) significantly improved gait endurance and functional independence in diabetic neuropathy patients, with sustained benefits at 2-month follow-up.
Foot biomechanics in diabetes mellitus patients has been studied, with an observational study of 281 patients finding no significant differences in joint mobility between patients with and without neuropathy.
Diabetic neuropathy significantly impairs ankle strength and balance recovery in older women, despite normal clinical muscle testing.
Despite the established benefits of exercise and physical therapy in managing diabetic polyneuropathy (DPN), significant knowledge gaps persist. Existing studies have primarily focused on isolated interventions, such as foot-ankle exercises or mindful walking, without exploring their combined effects. The synergistic potential of integrating therapeutic exercises with mindfulness-based walking remains uninvestigated. Insufficient evidence supports optimal exercise protocols and mindfulness-based interventions for DPN management. This study addresses these gaps, paving the way for evidence-based DPN management strategies.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Foot-Ankle therapeutic exercises and Mindful Walking., Standard care with Mindful walking.
- Keywords
- Pain, Quality of life, Foot-Ankle therapeutic Exercises, Mindful Walking, Diabetic Polyneuropathy, Foot and Ankle Disability
- Medical subject headings
- Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot-Ankle therapeutic exercises and Mindful Walking.Other
The intervention consists of Foot-Ankle Therapeutic Exercises combined with Mindful Walking, specifically designed to address diabetic neuropathy symptoms. This 12-week program includes strengthening exercises such as toe spreads, toe curls, heel raises, calf raises, single leg stance, and ankle dorsiflexion, as well as flexibility exercises like ankle dorsiflexion stretch, plantar fascia stretch, calf stretch, toe flexion stretch, and Achilles tendon stretch. Alongside these exercises, participants will engage in mindful walking practices incorporating sensory cues (kinesthetic, visual, auditory, and tactile cues). The unique combination and structured progression of these exercises and mindfulness techniques distinguish this intervention from other therapeutic approaches.
Standard care with Mindful walking.Other
The intervention consists of Foot-Ankle Therapeutic Exercises combined with Mindful Walking, specifically designed to address diabetic neuropathy symptoms. This 12-week program includes strengthening exercises such as toe spreads, toe curls, heel raises, calf raises, single leg stance, and ankle dorsiflexion, as well as flexibility exercises like ankle dorsiflexion stretch, plantar fascia stretch, calf stretch, toe flexion stretch, and Achilles tendon stretch. Alongside these exercises, participants will engage in mindful walking practices incorporating sensory cues (kinesthetic, visual, auditory, and tactile cues). The unique combination and structured progression of these exercises and mindfulness techniques distinguish this intervention from other therapeutic approaches.
| Study group | Role | What they receive |
|---|---|---|
| Foot-Ankle therapeutic exercises and Mindful Walking | Active comparator | Participants will receive 12 weeks program of foot-ankle therapeutic exercises combined with mindful walking. The intervention arm will consist of an 12-weeks program combining foot-ankle therapeutic exercises and mindful walking. Participants will attend sessions three times a week, with each session lasting 30 minutes for both exercises and mindful walking. The foot-ankle therapeutic exercises will include strengthening exercises like toe spreads, toe curls, heel raises, and calf raises, as well as flexibility exercises such as ankle dorsiflexion stretch, plantar fascia stretch, and calf stretch. The exercises will progress in intensity and difficulty over the 12-week period. Mindful walking sessions will incorporate sensory cues, including kinesthetic, visual, auditory, and tactile cues. Assessments will be conducted at baseline and 12 weeks to evaluate pain, foot and ankle disability, and quality of life. Receives: Other: Standard care with Mindful walking. |
| Standard Care and Mindful Walking | Active comparator | Participants will receive 12 weeks program of standard care combined with Mindful walking. Group 2 will receive standard care combined with mindful walking for 12 weeks. Participants will attend sessions three times a week, with each session lasting 30 minutes. The mindful walking sessions will incorporate sensory cues, including kinesthetic cues, visual cues, auditory cues, and tactile cues. The standard care will be provided alongside the mindful walking intervention. Assessments will be conducted at baseline and 8 weeks to evaluate pain, foot and ankle disability, and quality of life. Receives: Other: Foot-Ankle therapeutic exercises and Mindful Walking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NRS) is scored by having a patient select a number from \(0\) to \(10\) to represent their pain level. A score of \(0\) indicates "no pain," while a score of \(10\) represents "the worst pain imaginable". The higher the number, the greater the intensity of the pain.
Measured: At baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start17 Oct 2024
- 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 PolyneuropathyStudies 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
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Tariq, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248631
- Sponsor's protocol ID
- REC/02104 Ayesha Ahsan Kamal
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking on Pain, Foot and Ankle Disability and Quality of Life in Patients With Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT07248631
- Acronym / sponsor ID
- REC/02104 Ayesha Ahsan Kamal
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Pain, Quality of life, Foot-Ankle therapeutic Exercises, Mindful Walking, Diabetic Polyneuropathy, Foot and Ankle Disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Nov 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.
The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. This study seeks to evaluate the efficacy of these interventions in improving clinical outcomes and enhancing the overall well-being of individuals with diabetic polyneuropathy.
Detailed description
A 12-week foot-ankle therapeutic exercise program has been found to show positive effects compared to usual care on fast-gait speed, foot-ankle range of motion, vibration sensitivity, and quality of life in people with diabetic neuropathy.
Mindful walking's efficacy for chronic low back pain management has been investigated, with a randomized controlled trial of 55 patients yielding no significant improvements in pain intensity, back function, or stress after 8 weeks.
Exercise therapy has been found to significantly improve gait function in patients with diabetic peripheral neuropathy. A systematic review of 9 randomized controlled trials (370 participants) showed that exercise therapy enhances 6-minute walk test, 10-meter walk test, and Tinetti scale outcomes, improving mobility and reducing fall risk.
Exercise shows therapeutic potential for sensory nerve disorders, improving symptoms in most cases. Benefits are seen in diabetic pain and nerve damage, with varying mechanisms underlying these effects. Exercise therapy enhances outcomes for various nerve-related disorders, improving symptoms by at least two times compared to no exercise.
A 12-week study found significant improvements in glycemic control and vascular function in patients with type 2 diabetes who practiced Buddhist walking meditation, whereas traditional walking only improved blood glucose levels and cardiovascular fitness.
A study on sensor-based interactive balance training with visual joint movement feedback found significant improvements in postural stability in patients with diabetic peripheral neuropathy. The intervention group demonstrated a 62.68% reduction in CoM sway with eyes closed.
Physical therapy has been shown to impact limited joint mobility in diabetic neuropathy patients. A study found significant joint mobility improvements after 10 sessions of passive joint mobilization, with near-normal mobility achieved after 20 sessions.
A 4-week multimodal treatment program (treadmill, muscle strengthening, balance training) significantly improved gait endurance and functional independence in diabetic neuropathy patients, with sustained benefits at 2-month follow-up.
Foot biomechanics in diabetes mellitus patients has been studied, with an observational study of 281 patients finding no significant differences in joint mobility between patients with and without neuropathy.
Diabetic neuropathy significantly impairs ankle strength and balance recovery in older women, despite normal clinical muscle testing.
Despite the established benefits of exercise and physical therapy in managing diabetic polyneuropathy (DPN), significant knowledge gaps persist. Existing studies have primarily focused on isolated interventions, such as foot-ankle exercises or mindful walking, without exploring their combined effects. The synergistic potential of integrating therapeutic exercises with mindfulness-based walking remains uninvestigated. Insufficient evidence supports optimal exercise protocols and mindfulness-based interventions for DPN management. This study addresses these gaps, paving the way for evidence-based DPN management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot-Ankle therapeutic exercises and Mindful Walking | Active comparator | Other: Standard care with Mindful walking.Participants will receive 12 weeks program of foot-ankle therapeutic exercises combined with mindful walking. The intervention arm will consist of an 12-weeks program combining foot-ankle therapeutic exercises and mindful walking. Participants will attend sessions three times a week, with each session lasting 30 minutes for both exercises and mindful walking. The foot-ankle therapeutic exercises will include strengthening exercises like toe spreads, toe curls, heel raises, and calf raises, as well as flexibility exercises such as ankle dorsiflexion stretch, plantar fascia stretch, and calf stretch. The exercises will progress in intensity and difficulty over the 12-week period. Mindful walking sessions will incorporate sensory cues, including kinesthetic, visual, auditory, and tactile cues. Assessments will be conducted at baseline and 12 weeks to evaluate pain, foot and ankle disability, and quality of life. |
| Standard Care and Mindful Walking | Active comparator | Other: Foot-Ankle therapeutic exercises and Mindful Walking.Participants will receive 12 weeks program of standard care combined with Mindful walking. Group 2 will receive standard care combined with mindful walking for 12 weeks. Participants will attend sessions three times a week, with each session lasting 30 minutes. The mindful walking sessions will incorporate sensory cues, including kinesthetic cues, visual cues, auditory cues, and tactile cues. The standard care will be provided alongside the mindful walking intervention. Assessments will be conducted at baseline and 8 weeks to evaluate pain, foot and ankle disability, and quality of life. |
Who may qualify
- Ages
- 40 to 75 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosed with diabetic polyneuropathy (DPN) confirmed by medical history and clinical examination.
- Experience pain and disability in foot/ankle, with a Numeric Pain Rating Scale (NPRS) score ≥ 4.
- Independent walking ability for at least 10 m.
- Age (40-75) years.
- Ability to understand and follow exercise instructions.
Key exclusion criteria (8 listed)
- Presence of an active plantar ulcer or gangrene.
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period.
- Arthroplasty and/or orthosis of lower limbs or indication of lower limb arthroplasty throughout the intervention period.
- Participating in other exercise programs or studies.
- Dementia or inability to give consistent information.
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 |
|---|---|---|
| Foot-Ankle therapeutic exercises and Mindful Walking.The intervention consists of Foot-Ankle Therapeutic Exercises combined with Mindful Walking, specifically designed to address diabetic neuropathy symptoms. This 12-week program includes strengthening exercises such as toe spreads, toe curls, heel raises, calf raises, single leg stance, and ankle dorsiflexion, as well as flexibility exercises like ankle dorsiflexion stretch, plantar fascia stretch, calf stretch, toe flexion stretch, and Achilles tendon stretch. Alongside these exercises, participants will engage in mindful walking practices incorporating sensory cues (kinesthetic, visual, auditory, and tactile cues). The unique combination and structured progression of these exercises and mindfulness techniques distinguish this intervention from other therapeutic approaches. | Other | Standard Care and Mindful Walking |
| Standard care with Mindful walking.The intervention consists of Foot-Ankle Therapeutic Exercises combined with Mindful Walking, specifically designed to address diabetic neuropathy symptoms. This 12-week program includes strengthening exercises such as toe spreads, toe curls, heel raises, calf raises, single leg stance, and ankle dorsiflexion, as well as flexibility exercises like ankle dorsiflexion stretch, plantar fascia stretch, calf stretch, toe flexion stretch, and Achilles tendon stretch. Alongside these exercises, participants will engage in mindful walking practices incorporating sensory cues (kinesthetic, visual, auditory, and tactile cues). The unique combination and structured progression of these exercises and mindfulness techniques distinguish this intervention from other therapeutic approaches. | Other | Foot-Ankle therapeutic exercises and Mindful Walking |
Primary outcome
Numeric Pain Rating Scale
Time frame: At baseline and 12 weeks
The Numeric Pain Rating Scale (NRS) is scored by having a patient select a number from \(0\) to \(10\) to represent their pain level. A score of \(0\) indicates "no pain," while a score of \(10\) represents "the worst pain imaginable". The higher the number, the greater the intensity of the pain.
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Fatima Tariq, MS 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 Foot-Ankle therapeutic exercises and Mindful Walking. in people with Diabetic Polyneuropathy, 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 7 inclusion and 8 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 25 Nov 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 Fatima Tariq, MS (923344255033, fatima.tariq@rihah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: At baseline and 12 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 25 Nov 2025.