- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07576179
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Punjab Province
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Sargodha, Punjab Province, Pakistan, 40100
- Dr. Faisal Masood Teaching Hospital, Sargodha
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Plantar intrinsic muscle exercises
Plantar Intrinsic Foot Exercises (PIFE), along with conventional therapy |
Plantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks. Warm-up, conventional therapy, and cool-down will be given. |
|
Eksperymentalny: Three-Dimensional ankle foot exercises
3D Ankle-Foot Exercises (3D-AFE), along with conventional therapy |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Tinetti Performance Oriented Mobility Assessment (POMA)
Ramy czasowe: 8th week
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Michigan Neuropathy Screening Instrument (MNSI)
Ramy czasowe: 8th week
|
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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Hira Jabeen, Riphah International University
- Główny śledczy: Hira Jabeen, MS-PT, Riphah International University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- REC/RCR & AHS/25/0236
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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