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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy

2 listopada 2026 zaktualizowane przez: Zainab Hassan, University of Management and Technology Lahore

Comparative Effects Of Sensory Reweighting And Mechanical Proprioceptive Facilitation Training On Static Balance, Functional Mobility And Fall Risk In Patients With Diabetic Peripheral Neuropathy

This randomized controlled trial aims to compare the effects of Sensory Reweighting and Mechanical Proprioceptive Facilitation Training on static balance, functional mobility, and fall risk in patients with diabetic peripheral neuropathy. Study design will be a randomized clinical trial. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation. Group A will receive either sensory reweighting exercises and Group B will receive mechanical proprioceptive facilitation training using the Blueidea Deep Muscle Massage Fascial Gun BLD-888 in combination with conventional therapy for six weeks. Outcome measures will include Nintendo Wii Balance Board for Static Balance, Timed Up and Go Test for Functional Mobility, and Fall Efficacy Scale for Fall Risk. Both groups will receive 18 sessions for a period of 6 weeks. Measurements of all the outcome variables will be taken at baseline, and post treatment. Results will be analyzed by using SPSS 25.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

44

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University of Management & Technology

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria

  • Patients diagnosed with Type 2 Diabetes Mellitus by a medical practioner and confirmed by using MNSI Questionnaire total score ranges from 0 to 13, with higher scores indicating greater neuropathic symptoms. A score of ≥4 indicates an abnormal/positive neuropathy screen. MNSI Physical Examination: Total score ranges from 0 to 10. A score of ≥2.5 indicates an abnormal/positive neuropathy screen.
  • Both Male and Female
  • Age between 40-75 years
  • Duration of diabetes ≥ 5 years
  • HbA1c >8%
  • Able to walk independently without assistive devices Exclusion Criteria
  • History of lower limb fractures, severe deformities (Claw toes / hammer toes with functional limitation, Significant limb length discrepancy, or Musculoskeletal problems (Hip osteoarthritis affecting mobility, Recent ligament injuries in 6 months, Severe plantar fasciitis)
  • Active foot ulcer, infection, or gangrene
  • History of recent lower limb surgery or trauma (within 6 months), including fractures, dislocations, joint replacement, ligament or tendon repair/injury, or other injuries involving the hip, knee, ankle, or foot
  • Amputation of lower limb
  • History of deep vein thrombosis (DVT)
  • History of severe vestibular and neurological disorders (e.g., stroke, Parkinson's disease), Diabetic Retinopathy and Diabetic Nephropathy

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Sensory Reweighting with conventional Physical Therapy

Sensory reweighting will be performed under four different sensory conditions including eyes closed on a firm surface, eyes open on a firm surface, eyes open on a foam surface and eyes closed on a foam surface. The exercise program will include double-leg stance, tandem stance, single leg stance, tandem walking/ forward and backward waling and sit to stand exercises without arm support. Only standing exercises will be performed on foam surface while eyes closed to ensure patient safety. Each exercise trial will be performed for 20-30 seconds under each condition with three repetitions per condition. Rest intervals of 30-60 seconds will be given between trials. The total duration of each session will be 15-20 minutes. Progression of exercise will be introduced gradually initially exercises with eyes open on firm surface during week 1-2, followed by eyes closed condition in 3-4 week and dual task activities will be introduced during week 5-6.

Sensory reweighting will be performed under four different sensory conditions including eyes closed on a firm surface, eyes open on a firm surface, eyes open on a foam surface and eyes closed on a foam surface. The exercise program will include double-leg stance, tandem stance, single leg stance, tandem walking/ forward and backward waling and sit to stand exercises without arm support. Only standing exercises will be performed on foam surface while eyes closed to ensure patient safety. Each exercise trial will be performed for 20-30 seconds under each condition with three repetitions per condition. Rest intervals of 30-60 seconds will be given between trials. The total duration of each session will be 15-20 minutes. Progression of exercise will be introduced gradually initially exercises with eyes open on firm surface during week 1-2, followed by eyes closed condition in 3-4 week and dual task activities will be introduced during week 5-6.

Aktywny komparator: Mechanical Proprioceptive Facilitation training with conventional Physical Therapy

Mechanical Proprioceptive Facilitation Training using Blueidea Deep Muscle Massage Fascial Gun BLD-888 percussion massage gun. Mechanical stimulation will be applied to the plantar surface of the foot, calf muscles, and anterior and posterior thigh muscles. The device will be applied perpendicular to the tissue at a moderate, patient-tolerable intensity level. Each treatment area will receive percussion stimulation for approximately 1-2 minutes with a total intervention duration of 8-10 minutes per session(38, 39). The intervention program will be conducted for 6 weeks, with 3 sessions per week total 18 treatment sessions.

Mechanical Proprioceptive Facilitation Training using Blueidea Deep Muscle Massage Fascial Gun BLD-888 percussion massage gun. Mechanical stimulation will be applied to the plantar surface of the foot, calf muscles, and anterior and posterior thigh muscles. The device will be applied perpendicular to the tissue at a moderate, patient-tolerable intensity level. Each treatment area will receive percussion stimulation for approximately 1-2 minutes with a total intervention duration of 8-10 minutes per session. The intervention program will be conducted for 6 weeks, with 3 sessions per week total 18 treatment sessions. Conventional treatment Range of motion exercises (ankle, knee, toes) included knee flexion and extension, ankle dorsiflexion and plantarflexion, ankle inversion and eversion, and toe flexion and extension, Alternate weight shifting (side-to-side) Seated calf raises Heel raises with support (standing) will be given to both groups.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Functional mobility through time up go test
Ramy czasowe: baseline and after 6 weeks

Timed Up and Go Test is a standardized test used for the assessment of functional mobility. Procedure of test includes the participant stands up from the chair, walks 03 meters, turns around, returns and sit down while the completion time is recorded in seconds. Lower completion time indicates better mobility while longer completion time indicates impaired functional mobility. Score less than 10 shows Freely Mobile, >10 indicate Mostly independent and score greater than 20 seconds is generally associated impaired mobility. The test has shown excellent intra-rater and inter-rater reliability with interclass correlation coefficient reported around 0.99, along with strong validity in older adults and patients with neurological impairments

baseline and after 6 weeks
Fall risk through Fall Efficacy Scale
Ramy czasowe: baseline and after 6 weeks

Fall Efficacy Scale is a 16 item self-reported questionnaire tool which measures fear of fall and self-confidence when carrying out activities of daily life. Individuals will be asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities. High scores means more fear of falling and less balance self-confidence. 16-19 low concern, 20-27 moderate concern and 28-64 high concern. The tool has been shown to have very good internal consistency, as evidenced

baseline and after 6 weeks
static balance through
Ramy czasowe: baseline and after 6 weeks

Nintendo Wii Balance Board was used to assess static balance. This device measured postural sway, weight-shifting ability and balance control through force-sensing technology) For the measurement of center of gravity (COG) a patient was asked to stand still on balance board and then the weight distribution over the left and right feet was evaluated (body center of gravity; BCG). As a result, the percentage of weight over each foot was recorded. The result of weight distribution was measured in the percentage on right and left and further analyzed as affected and normal side. The Basic Balance Test involved shifting weight Mediolaterally to direct the center of pressure to target areas on the display. The Wii instructions were "spread your feet apart; lean left and right to keep the red bar in blue area for three seconds". The test had five possible levels with a time limit of 30 seconds to complete all levels.

baseline and after 6 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 października 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

31 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

20 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 października 2026

Pierwszy wysłany (Rzeczywisty)

27 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • RE-203-2026

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The results data collected; de-identified individual participant data will be shared.

Ramy czasowe udostępniania IPD

6 months after the publication of the manuscript.

Kryteria dostępu do udostępniania IPD

The data can be requested from the corresponding author.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .