Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking in Patients With Diabetic Polyneuropathy

NCT07248631 | Recruiting

• 1 other identifier: REC/02104 Ayesha Ahsan Kamal
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Polyneuropathy

Keywords

Pain; Quality of life; Foot-Ankle therapeutic Exercises; Mindful Walking; Diabetic Polyneuropathy; Foot and Ankle Disability

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and 12 weeks

Study Arms (2)

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.

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.

Other: Foot-Ankle therapeutic exercises and Mindful Walking.

Interventions

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 and Mindful Walking

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.

Foot-Ankle therapeutic exercises and Mindful Walking

Eligibility Criteria

• Age: 40 Months - 75 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Nishtar 2

Multan, Punjab Province, 60000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fatima Tariq, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Tariq, MS

CONTACT

923344255033; fatima.tariq@rihah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 17, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)