Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Other: Plantar cutaneous sensory stimulation; Other: Traditional physical therapy

• Registration Number: NCT06292468
• Lead Sponsor: Riphah International University

Brief Summary

To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Primary Completion: 2023-08-18
• Study Completion: 2023-09-18
• Study First Submitted: 2024-01-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ranged between 45-67 years.
• Both male and female genders are included.
• DM for the past 7 years.
• Scored > 2/13 on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire including at least two DPN symptoms.
• Scored >1/10 on MNSI physical assessment including impaired vibration perception

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Exclusion Criteria

• Loss of protective foot sensation (defined as a lack of response to the monofilament of the sensory evaluation instrument).
• Comorbidities include visual impairment, cerebrovascular accident, orthopedic trauma, labyrinthitis, peripheral vascular disease, and heart failure.
• Foot ulcers, orthopedic or surgical problems in a lower limb, other neurological impairment.
• Use of assistive devices for ambulation.
• Inability to walk independently with or without an assistive device.
• Receiving any structured supervised physiotherapy intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plantar cutaneous sensory stimulation.	Plantar cutaneous sensory stimulation	This group received plantar cutaneous sensory stimulation along with conventional physical therapy protocol and foot care guidelines.
Traditional physical therapy	Traditional physical therapy	This group received conventional physical therapy protocol along with foot care guidelines.

Primary Outcome Measures

Name	Time	Method
Foot tactile sensitivity	6th week	Semmes Weinstein monofilaments, Foot tactile sensitivity loss, commonly assessed by monofilaments, is a fall risk factor among older adults. The broadly used threshold of the monofilament for fall risk assessment in older adults is 5.07
Postural control	6th week	Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest) designed to assess 6 different aspects contributing to postural control in standing and walking. It consist of 27 tasks, with 36 items in total. Each items is scored based on ordinal scale scoring from 0- 3 where 3 representing best performances and 0 representing worst performances. Scores for the total test is provided as a percentage of total points i.e. 108. In addition, 6 sub-systems scores can be generated separately in percentage of total score each representing a specific balance system
Spatiotemporal gait parameters	6th week	By using a stopwatch and measuring tape

Trial Locations

Locations (2)

Allied Hospital Faisalabad.; 🇵🇰 Faisalābad, Punjab, Pakistan

PhysioFit; 🇵🇰 Faisalabad, Punjab, Pakistan