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

2 november 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

44

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Aktiv 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional mobility through time up go test
Tidsram: 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
Tidsram: 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
Tidsram: 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

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Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 oktober 2026

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

20 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

20 oktober 2026

Första postat (Faktisk)

27 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

6 months after the publication of the manuscript.

Kriterier för IPD Sharing Access

The data can be requested from the corresponding author.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

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