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Diabetic Peripheral Neuropathy (DPN)NCT07576179

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

A study testing Plantar intrinsic foot exercises and Three-Dimensional ankle foot exercises in people with Diabetic Peripheral Neuropathy (DPN), run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Diabetic Peripheral Neuropathy (DPN)
What is being tested?
Plantar intrinsic foot exercises and Three-Dimensional ankle foot exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
20 Apr 2026to 20 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Dr. Faisal Masood Teaching Hospital, Sargodha

    Sargodha, Punjab Province, 40100

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Plantar intrinsic foot exercises, Three-Dimensional ankle foot exercises
Keywords
Diabetic peripheral neuropathy, balance, gait, Plantar intrinsic muscle exercises, Three-Dimensional ankle foot exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plantar intrinsic foot exercisesOther

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

  • Three-Dimensional ankle foot exercisesOther

    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.

Study groups in NCT07576179
Study groupRoleWhat they receive
Plantar intrinsic muscle exercisesActive comparatorPlantar Intrinsic Foot Exercises (PIFE), along with conventional therapy
Receives: Other: Plantar intrinsic foot exercises
Three-Dimensional ankle foot exercisesExperimental3D Ankle-Foot Exercises (3D-AFE), along with conventional therapy
Receives: Other: Three-Dimensional ankle foot exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8th week

Secondary outcomes (1)
  1. 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.

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start20 Apr 2026
  3. Primary completion5 Aug 2026
  4. Study completion20 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07576179
Sponsor's protocol ID
REC/RCR & AHS/25/0236
Status last verified
Sep 2026
First submitted
4 May 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37126537
  • 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, 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.

    PubMed 39050517
  • 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.

    PubMed 39593566
  • 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 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.

    PubMed 32916792
  • 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.

    PubMed 35534614
  • 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

  • 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.

    PubMed 33019530
  • 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.

    PubMed 33610435
  • 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.

    PubMed 39033125
  • 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.

    PubMed 33905633
  • 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.

    PubMed 38646253
  • 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.

    PubMed 40364867

Questions about this trial

What is this clinical trial studying?

A study testing Plantar intrinsic foot exercises and Three-Dimensional ankle foot exercises in people with Diabetic Peripheral Neuropathy (DPN), run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinetti Performance Oriented Mobility Assessment (POMA) (time frame: 8th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07576179, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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