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

NCT ID: NCT07128836

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-08-15

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

proprioceptive training exercise and receive insole vibrator

Intervention Type: 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 B

Participants in this arm will receive only proprioceptive training exercise along with simple insoles without vibration.

Group Type: ACTIVE_COMPARATOR

proprioceptive training exercise along with simple insoles without vibration

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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

Faisalābad, , Pakistan

Countries

Pakistan

Other Identifiers

REC/0263 Rabia Shahzadi

Identifier Type: -

Identifier Source: org_study_id