NCT07896382|Active Not RecruitingDMC
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Sponsor study identifier
interventional
44
1 country
1
Study Start
October 19, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Functional mobility through time up go test
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
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
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.
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.
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.
University of Management & Technology
Lahore, Punjab Province, 54000, Pakistan
44 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2026
First Posted
October 27, 2026
Study Start
October 19, 2026
Actual (reported)static balance through
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
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.
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Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
The results data collected; de-identified individual participant data will be shared.
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