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

NCT07576179 | Completed

• 1 other identifier: REC/RCR & AHS/25/0236
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

Diabetic peripheral neuropathy; balance; gait; Plantar intrinsic muscle exercises; Three-Dimensional ankle foot exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Michigan Neuropathy Screening Instrument (MNSI)

  8th week

Study Arms (2)

Plantar intrinsic muscle exercises

ACTIVE COMPARATOR

Plantar Intrinsic Foot Exercises (PIFE), along with conventional therapy

Other: Plantar intrinsic foot exercises

Three-Dimensional ankle foot exercises

EXPERIMENTAL

3D Ankle-Foot Exercises (3D-AFE), along with conventional therapy

Other: Three-Dimensional ankle foot exercises

Interventions

Plantar intrinsic foot exercises OTHER

Plantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given.

Plantar intrinsic muscle exercises

Three-Dimensional ankle foot exercises OTHER

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.

Three-Dimensional ankle foot exercises

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Dr. Faisal Masood Teaching Hospital, Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

Related Publications (14)

• Willemse L, Wouters EJM, Pisters MF, Vanwanseele B. Plantar intrinsic foot muscle activation during functional exercises compared to isolated foot exercises in younger adults. Physiother Theory Pract. 2024 Aug;40(8):1656-1668. doi: 10.1080/09593985.2023.2204947. Epub 2023 Apr 26.

  PMID: 37126537 BACKGROUND

• 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.

  BACKGROUND

• Alissa N, Shipper AG, Zilliox L, 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. Clin Interv Aging. 2024 Jul 19;19:1325-1339. doi: 10.2147/CIA.S459492. eCollection 2024.

  PMID: 39050517 BACKGROUND

• Jimenez-Mazuelas MJ, Gonzalez-Perez de Villar N, De Casas-Albendea S, Martinez-Gimeno L, Jimenez-Gonzalez S, Angulo-Carrere MT. Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:2062-2073. doi: 10.1016/j.jbmt.2024.10.041. Epub 2024 Oct 24.

  PMID: 39593566 BACKGROUND

• 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.

  BACKGROUND

• Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. 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 (Basel). 2020 Sep 9;20(18):5129. doi: 10.3390/s20185129.

  PMID: 32916792 BACKGROUND

• Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0.

  PMID: 35534614 BACKGROUND

• 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

  BACKGROUND

• Park DJ, Hwang YI. Comparison of the Intrinsic Foot Muscle Activities between Therapeutic and Three-Dimensional Foot-Ankle Exercises in Healthy Adults: An Explanatory Study. Int J Environ Res Public Health. 2020 Oct 1;17(19):7189. doi: 10.3390/ijerph17197189.

  PMID: 33019530 BACKGROUND

• Shin KJ, Kang JW, Sung KH, Park SH, Kim SE, Park KM, Ha SY, Kim SE, In Lee B, Park J. Quantitative gait and postural analyses in patients with diabetic polyneuropathy. J Diabetes Complications. 2021 Apr;35(4):107857. doi: 10.1016/j.jdiacomp.2021.107857. Epub 2021 Jan 17.

  PMID: 33610435 BACKGROUND

• Willemse L, Wouters EJM, 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 Sci Med Rehabil. 2024 Jul 20;16(1):158. doi: 10.1186/s13102-024-00944-z.

  PMID: 39033125 BACKGROUND

• de Oliveira Lima RA, Piemonte GA, Nogueira CR, Dos Santos Nunes-Nogueira V. Efficacy of exercise on balance, fear of falling, and risk of falls in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis. Arch Endocrinol Metab. 2021 Nov 1;65(2):198-211. doi: 10.20945/2359-3997000000337. Epub 2021 Feb 24.

  PMID: 33905633 BACKGROUND

• Francis D, Kandaswami K, Padinhare Veedu P, Ponniah Subramanian A. Effect of Exercises for Strengthening the Intrinsic Muscles of the Foot and Improving Ankle Mobility on Patients of Diabetic Peripheral Neuropathy. Cureus. 2024 Mar 20;16(3):e56553. doi: 10.7759/cureus.56553. eCollection 2024 Mar.

  PMID: 38646253 BACKGROUND

• 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. Front Aging. 2025 Apr 29;6:1507232. doi: 10.3389/fragi.2025.1507232. eCollection 2025.

  PMID: 40364867 BACKGROUND

Study Officials

• Hira Jabeen, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Hira Jabeen

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized for RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: April 20, 2026
• Primary Completion: August 5, 2026
• Study Completion: August 20, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)