Plantar Intrinsic Muscles Exercises and Three-dimensional Ankle Foot Exercises Comparative Effect in DPN

Comparative Effects of Plantar Intrinsic Muscles Exercises and 3-dimensional Ankle Foot Exercises on Balance, Gait and Fall Risk in Patients With Diabetic Peripheral Neuropathy

The aim of this study is to determine the comparative effects of plantar intrinsic muscles exercises and three-dimensional ankle foot exercises on balance, gait and fall risk in patients with diabetic peripheral neuropathy.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: Other: Plantar intrinsic foot exercises; Other: Three-Dimensional ankle foot exercises

Detailed Description

Diabetic Peripheral Neuropathy (DPN) is among the most common and disabling complications of diabetes mellitus, affecting up to 50% of long-term diabetic patients. Patients commonly present with symmetrical sensory loss (distal extremities), paresthesia, muscle weakness and atrophy (particularly of intrinsic foot musculature), impaired proprioception and vibration sense. Plantar intrinsic muscles exercises target the tiny, stabilizing muscles within the foot particularly, improving intrinsic support and arch integrity, whereas three-dimensional ankle foot exercises place an emphasis on multidirectional motions that increase joint mobility, neuromuscular coordination, and general lower limb strength. The aim of this study is to determine comparative effects of plantar intrinsic muscles exercises and three-dimensional ankle foot exercises on balance, gait and fall risk in patients with diabetic peripheral neuropathy.

This study will be a single-blinded randomized clinical trial. Non probability convenience sampling will be used to recruit 40 patients of either gender, aged 50-75 years, and diagnosed with Diabetic peripheral neuropathy (DPN). This study will be carried out in Dr. Faisal Masood Teaching Hospital, Sargodha. These participants will be randomly allocated to Group A and Group B through computerized table generator method. Group A will receive plantar intrinsic muscle exercises, whereas group B will receive three-dimensional ankle foot exercises. Both groups will perform their respective exercises 40 minutes, thrice a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Michigan Neuropathy Screening Instrument (MNSI) and Tinetti Performance Oriented Mobility Assessment (POMA) to assess the effect of this intervention on balance, gait and fall risk. Data will be analyzed by SPSS version 27.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, Phd; Phone Number: 033324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Sargodha, Punjab Province, Pakistan, 40100
      • Recruiting
      • Dr. Faisal Masood Teaching Hospital, Sargodha
      • Contact: Hira Jabeen
      • Principal Investigator: Amna Ahmad, MS-PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The participants who scored ≥ 7 (abnormal) as per the Michigan Neuropathy Screening Instrument (MNSI)
• Able to ambulate 10 m barefoot without using a walking aid
• Patient reporting to have either fear of falling or experienced a fall in the previous 12 months
• Cognitive Function on Mini-Mental State Examination is normal (MMSE score: Above 25)
• Patients having difficulties with mobility, gait, or balance in daily life

Exclusion Criteria:

• Presence of other neurological conditions (GBS, Paraneoplastic Neuropathy, Infectious Neuropathy, others)
• Severe Retinopathy, a vascular complication of DM.
• Limited Ankle and foot ROM due to fracture or contracture.
• Presence of active plantar ulcers.
• Recent surgeries or injuries in the foot/lower limb.
• Musculoskeletal disorders affecting gait (Osteoarthritis, Rheumatoid arthritis, Muscular dystrophy, Hip dysplasia, others)
• Participation in another rehabilitation or training concurrently

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plantar intrinsic muscle exercises; Plantar Intrinsic Foot Exercises (PIFE), along with conventional therapy	Other: Plantar intrinsic foot exercises; Plantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.
Experimental: Three-Dimensional ankle foot exercises; 3D Ankle-Foot Exercises (3D-AFE), along with conventional therapy	Other: Three-Dimensional ankle foot exercises; 3D Ankle-Foot Exercises (3D-AFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinetti Performance Oriented Mobility Assessment (POMA)	Changes from baseline Tinetti Performance Oriented Mobility Assessment (POMA) is clinical instrument for assessing balance and gait function in patients with neurological or musculoskeletal disorders as well as older patients. Scores of 25-28 indicate low fall risk, 19-24 medium fall risk, and < 19 high fall risk.	8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Neuropathy Screening Instrument (MNSI)	Changes from baseline, the Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument consists of 15 self-administered questions on foot sensation including pain, numbness and temperature sensitivity. The second part of the MNSI is a brief physical examination involving 1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection, (2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe, (3) grading of ankle reflexes and, (4) monofilament testing.	8th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Hira Jabeen, Riphah International University; Principal Investigator: Hira Jabeen, MS-PT, Riphah International University

Publications and helpful links

General Publications

• Willemse L, Wouters EJ, Pisters MF, Vanwanseele B. Plantar intrinsic foot muscle activation during functional exercises compared to isolated foot exercises in younger adults. Physiotherapy Theory and Practice. 2024;40(8):1656-68.
• Waheed A, Azharuddin M, Ahmad I, Noohu MM. Whole-body vibration, in addition to balance exercise, shows positive effects for strength and functional ability in patients with diabetic peripheral neuropathy: A single-blind randomized controlled trial. Journal of Diabetology. 2021;12(4):456-63.
• Alissa N, Goldstein SA, Lindsay Z, and Westlake KP. A Systematic Review of the Effect of Physical Rehabilitation on Balance in People with Diabetic Peripheral Neuropathy Who are at Risk of Falling. Clinical Interventions in Aging. 2024;19(null):1325-39.
• Jimenez-Mazuelas M, de Villar NG-P, De Casas-Albendea S, Martinez-Gimeno L, Jimenez-Gonzalez S, Angulo-Carrere M. Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial. Journal of Bodywork and Movement Therapies. 2024;40:2062-73.
• Vellacita G, Dewi P, editors. The Effectiveness of Diabetic Foot Exercise to Peripheral Neuropathy Symptoms and Fasting Blood Glucose in Type 2 Diabetes Patients. Proceedings of the International Conference of Health Development Covid-19 and the Role of Healthcare Workers in the Industrial Era (ICHD 2020); 2020 2020/11/25: Atlantis Press.
• Monteiro RL, Ferreira JS, Silva ÉQ, Donini A, Cruvinel-Júnior RH, Verissímo JL, et al. Feasibility and preliminary efficacy of a foot-ankle exercise program aiming to improve foot-ankle functionality and gait biomechanics in people with diabetic neuropathy: A randomized controlled trial. Sensors. 2020;20(18):5129.
• Monteiro RL, Ferreira JS, Silva ÉQ, Cruvinel-Júnior RH, Veríssimo JL, Bus SA, et al. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: A randomized controlled trial. Scientific reports. 2022;12(1):7561.
• Jaha GN. Effectiveness of Functional Strength Training and Balance Training on Postural Stability and Gait in Patients with Diabetic Peripheral Neuropathy to Reduce the Risk of Falls
• ark D-J, Hwang Y-I. Comparison of the intrinsic foot muscle activities between therapeutic and three-dimensional foot-ankle exercises in healthy adults: An explanatory study. International Journal of Environmental Research and Public Health. 2020;17(19):7189.
• Shin KJ, Kang JW, Sung KH, Park SH, Kim SE, Park KM, et al. Quantitative gait and postural analyses in patients with diabetic polyneuropathy. Journal of Diabetes and its Complications. 2021;35(4):107857.
• Willemse L, Wouters EJ, Pisters MF, Vanwanseele B. Effects of a 12-week intrinsic foot muscle strengthening training (STIFF) on gait in older adults: a parallel randomized controlled trial protocol. BMC Sports Science, Medicine and Rehabilitation. 2024;16(1):158.
• Lima RAdO, Piemonte GA, Nogueira CR, Nunes-Nogueira VdS. Efficacy of exercise on balance, fear of falling, and risk of falls in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis. Archives of endocrinology and metabolism. 2021;65:198-211.
• rancis D, Kandaswami K, Veedu PP, Subramanian AP. Effect of exercises for strengthening the intrinsic muscles of the foot and improving ankle mobility on patients of diabetic peripheral neuropathy. Cureus. 2024;16(3).
• Pang X, Wang D, Zhang F, Guo B, Liu W. Exploring the exercise for enhancing postural control, gait, and muscle strength in older adults with diabetic peripheral neuropathy: a systematic review and meta-analysis. Frontiers in Aging. 2025;6:1507232.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 20, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: gait; balance; Diabetic peripheral neuropathy; Plantar intrinsic muscle exercises; Three-Dimensional ankle foot exercises
• Other Study ID Numbers: REC/RCR & AHS/25/0236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No