Clinical trial NCT06292468: Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy
Official title: Effects of Plantar Cutaneous Sensory Stimulation on Foot Tactile Sensitivity, Postural Control, and Spatiotemporal Gait Parameters in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Diabetic neuropathy
Gait parameters
Plantar cutaneous stimulation
Postural instability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Foot tactile sensitivity
timeFrame: 6th week
measure: Postural control
timeFrame: 6th week
measure: Spatiotemporal gait parameters
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: PhysioFit
state: Punjab
city: Faisalābad
country: Pakistan
facility: Allied Hospital Faisalabad.
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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