Effects of Insole Vibration With Proprioceptive Training in Patients With Diabetic Peripheral Neuropathy

Effects of Insole Vibration With Proprioceptive Training on Balance and Functional Ability in Patients With Diabetic Peripheral Nuropathy

Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, profoundly affecting quality of life with sensory disturbances and associated complications. Proprioceptive training shows promise in improving proprioception and functional outcomes in patients with peripheral neuropathy. Also the literature has shown that Insole vibrator demonstrates potential in mitigating symptoms and improving sensory function and balance in patients with peripheral neuropathy. This study aims to determine the effects of insole vibration with proprioceptive training on balance and functional ability in patient with diabetic peripheral neuropathy.

In this randomized controlled trial design, 60 participants will be recruited. The sample size was calculated through G-power total of 60 participants. Who meet the inclusion criteria will be recruited through non-probability convenience sampling technique, which will further be randomized through online randomizer tool into control and experimental group with thirty participants in each group. Experimental group will receive proprioceptive training alongside vibrating insole and control group will receive proprioceptive training with non vibrating insoles. Data will be collected by using various assessment tools, including Numeric Pain Rating Scale for pain,Time Up And Go Test for functional mobility, Neuropathic Disability Score for level of disability ,Functional Reach Test for standing stability, Mini BESTS for balance, functional mobility and gait, Single Leg Stance Test for static posture and balance control and the Montreal Cognitive Assessment for cognitive impairment. Pre-intervention assessments will be conducted for both groups. The effects of the interventions will be measured at pre-treatment, 6th week, 12th week and at 16th week. Data analysis will be performed by using SPSS 26. Mixed ANOVA and repeated-measures ANOVA will use for within-group analysis whereas between-group analysis will perform by using one-way ANOVA.

Key words: Diabetic polyneuropathy, Vibrating insole, proprioceptive training, balance

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: Other: proprioceptive training exercise and receive insole vibrator; Other: proprioceptive training exercise along with simple insoles without vibration

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Faisalābad, Pakistan, 54660
    • Chiniot General Hospital and Civil Hospital (Allied 2), Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients with both genders male and female will be included

  • The age limit for the patients will be from 50 to 70 years
  • Patients diagnosed with DPN type 1 or type 2
  • Patients with neuropathic disability score greater than 3 will be included
  • Patients with Michigan questionnaire higher than 3
  • Patients who can walk independently with BBS score between 41 to 56

Exclusion Criteria:

• Patients with Mini Mental State less than 24
• Patients having Numeric Pain Rating Scale greater than 4
• Patients with any impairment in lower leg e.g; Leg Length Discrepancy, foot ulcer, lower limb injury

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants in this arm will perform both proprioceptive training exercises and receive insole vibrator.	Other: proprioceptive training exercise and receive insole vibrator; The treatment for the participants in the experimental group includes; 5 minutes warm up, 30 minutes proprioceptive training exercise, 20 minutes walk with in-sole vibrator, 5 minutes cool down. The duration of each session will be 60 minutes. All the participants will receive 36 sessions (3 times per week over 12 week's period).
Active Comparator: Group B; Participants in this arm will receive only proprioceptive training exercise along with simple insoles without vibration.	Other: proprioceptive training exercise along with simple insoles without vibration; The treatment for the participants in the control group includes; 5 minutes warm up, 30 minutes proprioceptive training exercise, 20 minutes walk with non-vibrating insole, 5 minutes cool down. The duration of each session will be 60 minutes. All the participants will receive 36 sessions (3 times per week over 12 week's period).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale (NPRS)	to measure pain scale range 0-10. zero means no pain 10 means maximum	Baseline after completion of 6 and 8 weeks
Time Up and Go (TUG) Test	To measure mobility and fall risk (time to rise, walk, return) measure in seconds time > 20 sec means impaired mobility	Baseline after completion of 6 and 8 weeks
Neuropathic Disability score (NDS)	Severity of PND (0-10 scale) 0 means no disability 10 means maximum disability	Baseline after completion of 6 and 8 weeks
Functional Reach test (FRT)	to measure anticipatory postural control Stability and fall risk	Baseline after completion of 6 and 8 weeks
Mini-BESTest	to measure static and dynamic balance (0-30 scale) greater score means better mobility	Baseline after completion of 6 and 8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Aruba Saeed, PhD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Diabetic polyneuropathy; Proprioceptive training; Vibrating insole,
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Complications; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: REC/0263 Rabia Shahzadi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No