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

NCT07128836 | Completed DMC

• 1 other identifier: REC/0263 Rabia Shahzadi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

Diabetic polyneuropathy; Vibrating insole,; Proprioceptive training; Balance

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Participants in this arm will perform both proprioceptive training exercises and receive insole vibrator.

Other: proprioceptive training exercise and receive insole vibrator

Group B

ACTIVE COMPARATOR

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

Interventions

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).

Group A

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).

Group B

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

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

Faisalābad, 54660, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Vibration

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: August 19, 2025
• Study Start: April 10, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)