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

November 2, 2026 updated by: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mobility through time up go test
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 20, 2026

First Submitted That Met QC Criteria

October 20, 2026

First Posted (Actual)

October 27, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

6 months after the publication of the manuscript.

IPD Sharing Access Criteria

The data can be requested from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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