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Development, Validation and Testing of Foot Sense Therapeutic Device in Patients with Diabetic Peripheral Neuropathy

Development, Validation and Feasibility Testing of a Proprioception and Vibration Sense Therapeutic Device in Patients with Diabetic Peripheral Neuropathy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105671
Enrollment
30
Registered
2026-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Plantar Vibration and Proprioception training: An intervention program includes 6 weeks (5 times per week), including gamified proprioceptive training and local plantar vibration. The o

Sponsors

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus induced diabetic peripheral neuropathy of lower limbs. Diabetes Duration minimum 5 years. HbA1C levels more than or equal to 6% and not older than 3 months. BMI and lt 30kg/m2.

Exclusion criteria

Exclusion criteria: Vestibular system dysfunction in the last year. Diabetic foot ulcer. Acute cardiovascular diseases. History of any recent lower limb injury or recent surgery. Patient with impaired vision. Patients with significant psychiatric disorders. Patient with Autonomic dysfunctions

Design outcomes

Primary

MeasureTime frame
Ankle Proprioception, Vibration Perception ThresholdTimepoint: The vibration perception scores with biothesiometer values and proprioception scores using the Pedalo-Sensamove Balance Test Pro and newly developed device will be taken at pre-intervention (Week zero) and post-intervention (Week 6)

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactProf Dr Manu Goyal

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

manugoyal1111@gmail.com8307715320

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026