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Clinical Trials/CTRI/2024/05/067744
CTRI/2024/05/067744CompletedNot Applicable

Association Between Plantar Pressure and Fall Risk in Patients with Diabetic Neuropathy: An Observation Study

Nitte Institute of Physiotherapy NITTEDeemed To be University1 site in 1 country100 target enrollmentStarted: July 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
1. Plantar pressure analysis system

Study Overview

Brief Summary

Diabetes mellitus (DM) is the collective term with main symptom of chronic hyperglycemia leading to one of the most important complication-Diabetic neuropathy. Diabetic patients with neuropathy are at high risk for the development of ulcers which might lead to falls due to high plantar pressure and sensory loss. Typically, in terms of diabetic neuropathy population, it is important to assess the factors that might cause falls in this population. As these populations are more prone to falls, factors responsible for falls should be identified. Physiotherapists who are qualified to prescribe exercise should know these factors with the goal of preventing falls. Additionally, comprehending the fall risk among the diabetic population is essential for conducting successful fall prevention programs and might aid in knowledge transfer to other developing nations. There is a dearth of studies that compare plantar pressure and fall risk in diabetic neuropathy patients in large populations between TUG and PP, using plantar pressure force systems (portable and wireless), especially in the Indian population. Hence, this study aims to find the association between plantar pressure and fall risk in diabetic neuropathy patients leading to falls. The result of the study will be useful for the therapist to rehabilitate and educate the patient about the fall risk and how to prevent it. In addition, these assessment methods are cost effective and portable which benefits the patient and the therapist.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
35.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • People diagnosed with Diabetic Neuropathy
  • People able to stand on both feet
  • People without foot ulcers
  • 10g Monofilament test ranging from 1.65 – 6.65.

Exclusion Criteria

  • Neurological disorders which affect balance and cognition
  • People with foot cons
  • Diabetic foot ulcers
  • Amputated lower limbs
  • Recent lower limb surgery past 6 months
  • Recent fractures of lower limb past 6 months
  • Recent falls within 6 months.

Outcomes

Primary Outcomes

1. Plantar pressure analysis system

Time Frame: Assessment will be taken once at the beginning of the study

2. TUG test

Time Frame: Assessment will be taken once at the beginning of the study

3. ABC-16 scale

Time Frame: Assessment will be taken once at the beginning of the study

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nitte Institute of Physiotherapy NITTEDeemed To be University
Sponsor Class
Other [ Nitte Institute of Physiotherapy, NITTE(Deemed To be University)]
Responsible Party
Principal Investigator
Principal Investigator

Brahmi

Nitte Institute of Physiotherapy

Study Sites (1)

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