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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foot-Ankle therapeutic exercises and Mindful Walking.

    Other intervention

    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 intervention

    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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Foot-Ankle therapeutic exercises and Mindful WalkingActive comparator 1 intervention
Group B: Standard Care and Mindful WalkingActive comparator 1 intervention

Trial outcomes

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.

Time frame
At baseline and 12 weeks

Secondary outcomes

Other outcomes

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