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Completed

NCT Number: NCT07128836

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

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

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Key information

Conditions

Diabetic Peripheral Neuropathy (DPN) Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiniot General Hospital and Civil Hospital (Allied 2), Faisalabad

Faisalābad, 54660, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proprioceptive training exercise and receive insole vibrator

Other

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).

proprioceptive training exercise along with simple insoles without vibration

Other

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).

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline after completion of 6 and 8 weeks

    to measure pain scale range 0-10. zero means no pain 10 means maximum

  2. Time Up and Go (TUG) Test

    Time frame: Baseline after completion of 6 and 8 weeks

    To measure mobility and fall risk (time to rise, walk, return) measure in seconds time > 20 sec means impaired mobility

  3. Neuropathic Disability score (NDS)

    Time frame: Baseline after completion of 6 and 8 weeks

    Severity of PND (0-10 scale) 0 means no disability 10 means maximum disability

  4. Functional Reach test (FRT)

    Time frame: Baseline after completion of 6 and 8 weeks

    to measure anticipatory postural control Stability and fall risk

  5. Mini-BESTest

    Time frame: Baseline after completion of 6 and 8 weeks

    to measure static and dynamic balance (0-30 scale) greater score means better mobility

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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