Actively Recruiting

Phase Not Applicable
Age: 40Months - 75Months
All Genders
ID07248631

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

Led by Riphah International University · Updated on 2025-11-25

38

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how combining foot-ankle therapeutic exercises with mindful walking affects pain, disability, and quality of life in people with diabetic polyneuropathy. This study aims to improve clinical outcomes and enhance overall well-being by assessing the combined effects of these therapies, addressing gaps in previous research that focused on these treatments separately. Participants will be randomly assigned to one of two groups for 12 weeks. One group will perform foot-ankle exercises including strengthening and flexibility movements alongside mindful walking sessions three times a week, each lasting 30 minutes. The other group will receive standard care combined with mindful walking sessions at the same frequency and duration. Mindful walking involves sensory cues such as kinesthetic, visual, auditory, and tactile inputs. Assessments take place at the start and end of the intervention period. During the study, participants will be evaluated for pain using the Numeric Pain Rating Scale, as well as foot and ankle disability and quality of life. Baseline and 12-week assessments will monitor changes. The study involves regular sessions to track adherence and progress. The total participation duration is 12 weeks, with safety and outcome measures carefully observed throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Months - 75Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with diabetic polyneuropathy confirmed by medical history and clinical examination
  • Experience foot or ankle pain and disability with a Numeric Pain Rating Scale score of 4 or higher
  • Able to walk independently for at least 10 meters
  • Aged between 40 and 75 years
  • Able to understand and follow exercise instructions
  • Have a maximum of one amputated toe, excluding the big toe
  • Willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Have an active plantar ulcer or gangrene
  • History of surgery at the knee, ankle, or hip or planned surgery during the study
  • Use of arthroplasty or orthosis on lower limbs or planned during the study
  • Currently participating in other exercise programs or studies
  • Diagnosis of dementia or inability to provide consistent information
  • Diagnosis of neurological diseases other than diabetic polyneuropathy
  • Neuropathic pain caused by other conditions like HIV or chemotherapy
  • Major vascular complications or severe retinopathy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants undergo a 12-week program combining foot-ankle therapeutic exercises and mindful walking to address diabetic neuropathy symptoms. Sessions occur three times a week, each lasting 30 minutes and include strengthening and flexibility exercises along with mindful walking practices incorporating sensory cues.

Three sessions per week

Follow-up

Duration - 1 day

Participants complete assessments at the end of the treatment period to evaluate pain, foot and ankle disability, and quality of life.

1 visit (in-person) at 12 weeks

Trial Site Locations

Total: 1 location

1

Nishtar 2

Multan, Punjab Province, Pakistan, 60000

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Research Team

F

Fatima Tariq, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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