Diabetic Peripheral Neuropathy (DPN)NCT07128836
Effects of Insole Vibration With Proprioceptive Training in Patients With Diabetic Peripheral Neuropathy
A study testing proprioceptive training exercise and receive insole vibrator and proprioceptive training exercise along with simple insoles without vibration in people with Diabetic Peripheral Neuropathy (DPN), run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- proprioceptive training exercise and receive insole vibrator and proprioceptive training exercise along with simple insoles without vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chiniot General Hospital and Civil Hospital (Allied 2), Faisalabad
Faisalābad, 54660
About this study
Official title: 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
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- proprioceptive training exercise and receive insole vibrator, proprioceptive training exercise along with simple insoles without vibration
- Keywords
- Diabetic polyneuropathy, Vibrating insole,, Proprioceptive training, Balance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive training exercise and receive insole vibratorOther
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 vibrationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in this arm will perform both proprioceptive training exercises and receive insole vibrator. Receives: 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. Receives: Other: proprioceptive training exercise along with simple insoles without vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
to measure pain scale range 0-10. zero means no pain 10 means maximum
Measured: 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
Measured: 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
Measured: Baseline after completion of 6 and 8 weeks
Functional Reach test (FRT)
to measure anticipatory postural control Stability and fall risk
Measured: Baseline after completion of 6 and 8 weeks
Mini-BESTest
to measure static and dynamic balance (0-30 scale) greater score means better mobility
Measured: Baseline after completion of 6 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 Apr 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128836
- Sponsor's protocol ID
- REC/0263 Rabia Shahzadi
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insole Vibration With Proprioceptive Training on Balance and Functional Ability in Patients With Diabetic Peripheral Nuropathy
- ClinicalTrials.gov ID
- NCT07128836
- Acronym / sponsor ID
- REC/0263 Rabia Shahzadi
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic polyneuropathy, Vibrating insole,, Proprioceptive training, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: proprioceptive training exercise and receive insole vibratorParticipants in this arm will perform both proprioceptive training exercises and receive insole vibrator. |
| Group B | Active comparator | Other: proprioceptive training exercise along with simple insoles without vibrationParticipants in this arm will receive only proprioceptive training exercise along with simple insoles without vibration. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients with both genders male and female will be included
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioceptive training exercise and receive insole vibratorThe 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). | Other | Group A |
| proprioceptive training exercise along with simple insoles without vibrationThe 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). | Other | Group B |
Primary outcome
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
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
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
Functional Reach test (FRT)
Time frame: Baseline after completion of 6 and 8 weeks
to measure anticipatory postural control Stability and fall risk
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive training exercise and receive insole vibrator and proprioceptive training exercise along with simple insoles without vibration in people with Diabetic Peripheral Neuropathy (DPN), run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline after completion of 6 and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.