Effectiveness of Neuromuscular Taping on Balance, Proprioception, Pain andNerve Conduction parameters in patients with Diabetic Peripheral Neuropathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1. Berg Balance Scale (BBS)
Study Overview
Brief Summary
Diabetic Peripheral Neuropathy (DPN) is defined as “the presence of symptoms or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. 60-70% of diabetic population experience mild to severe damage to nervous system which leads to DPN which usually involves distal body parts and is characterised as distal symmetrical sensorimotor neuropathy which is progressive in nature and follows a "glove and stocking pattern". DPN is found to be more associated with Type 1 diabetes mellitus (DM) (90-95%) compared to Type 1 DM. Interaction of metabolic and vascular factors are responsible for peripheral neuropathy. Physiotherapy has been an option for the management of DPN. There is plenty of literature available in treating DPN using various physiotherapeutic approach but there is scarcity of literature stating the effects of Neuromuscular Taping (NMT) for the management of DPN. NMT has emerged as an effective approach to treat musculoskeletal and neurological conditions but this concept has never been explored to treat balance, proprioception, pain and nerve conduction parameters in patients with DPN, thereby, making it the real need of time to explore.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Referred cases of Type 1 & Type 2 diabetes mellitus induced diabetic peripheral neuropathy of lower limbs diagnosed by physician and score more than 2/13 on MNSI physical appearance section and scored greater than 1/10 on physical examination of Michigan neuropathy screening instrument (MNSI)
- •Diabetes duration: ≥5 years
- •Age between 40 to 70 years 4.Chronic symmetric sensorimotor involvement of bilateral lower limb after excluding all other causes of peripheral neuropathies
- •Leeds Assessment of Neuropathic Symptoms Scale (LANSS) score > 12 6.Berg Balance Scale (BBS)<45
- •HbA1C report ≥6% not older than 3 months
- •Willing to participate
- •BMI <30kg/m2 (According to Asian criterion).
Exclusion Criteria
- •Allergic to tape
- •Any other diagnosed neuromuscular disease
- •Vestibular system dysfunction in the last one year (complaint of dizziness, vertigo, nausea and loss of balance) 4.Diabetic foot ulcers, neuropathic joint, charcot joint
- •History of any recent injury (soft tissue and bony) in lower limb six months prior to participation in study
- •Patients with rheumatoid arthritis
- •Patients with varicose veins
- •Any other cause of balance and gait disturbance
- •Deformities of lower limb 10.
Outcomes
Primary Outcomes
1. Berg Balance Scale (BBS)
Time Frame: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument
2. Pedalo®-Sensamove Balance Test Pro with Miniboard
Time Frame: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument
3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale
Time Frame: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument
4.Nerve Conduction Velocity (NCV)
Time Frame: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument
5. Michigan Neuropathy Screening Instrument
Time Frame: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument
Secondary Outcomes
- NA(NA)