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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in this arm will perform both proprioceptive training exercises and receive insole vibrator. |
|
| Group B | Active Comparator | Participants in this arm will receive only proprioceptive training exercise along with simple insoles without vibration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
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Inclusion Criteria:
• Patients with both genders male and female will be included
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aruba Saeed, PhD | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiniot General Hospital and Civil Hospital (Allied 2), Faisalabad | Faisalābad | 54660 | Pakistan |
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| 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). |
|
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014732 | Vibration |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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