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Clinical Trials/NCT05922280
NCT05922280
Completed
Not Applicable

Effect of Subtalar and Talocrural Joint Mobilization on Foot Ranges and Posture in Diabetics

Riphah International University1 site in 1 country41 target enrollmentFebruary 15, 2023
ConditionsDiabetic Foot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Riphah International University
Enrollment
41
Locations
1
Primary Endpoint
Douleur Neuropathique 4 Questionnaire DN4
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this research is to determine the Effects of mobilizations on foot ranges and posture in people with Type 2 Diabetes Mellitus. Randomized controlled trials will be done at Dr. Akbar Niazi Teaching Hospital ANTH, Bhara kahu Islamabad. The sample size will be 42. The subjects were divided in two groups, with 21 subjects in Group A and 21 in Group B. Study duration is 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 45-65 having Type 2 Diabetes were included. Tools used in the study are Spirit Level Mobile Application (android)-Smartphone Goniometer, Foot Posture Index-6 and DN4-Douleur Neuropathique 4 Questionnaire.

Detailed Description

Diabetes mellitus is a heterogeneous metabolic disease due to insulin disturbance affecting around 422 Million people worldwide according to the WHO it is characterized by hyperglycemia and ischemia, as a result of defects in insulin secretion. Type 2 diabetes mellitus (T2DM) ranks highly on the international health agenda as a global pandemic and as a threat to human health and global economies. The number of people with T2DM worldwide has more than doubled during the past 20 years. Lower extremity musculoskeletal complications are frequently observed in people with diabetes mellitus (DM) and peripheral neuropathy (PN) and include limited joint mobility, impaired strength, atrophy causing increased stiffness of articular capsule, ligaments and tendons. Ankle planter flexion and dorsiflexion was found to be decreased preventing the ankle from reaching its closed-pack position by holding the ankle in a hyper supinated position. People with DMPN have a dorsi flexed foot and ankle position resulting in slow gait with prolonged disease secondary to the peripheral effect of the disease on other body systems. According to Abate and colleagues there is a 24% reduction in ankle plantar-flexion range of motion in people with DM. Manual mobilizations have proved to decrease the stiffness at ankle joint improving the ranges in previous studies Previous literature have shown that Interventions to address foot and ankle plantar-flexion mobilizations could improve its function by increasing flexibility reduce the risk of plantar ulceration. Distraction of the distal tibiofibular joint has been thought to increase space and decrease impingement in the talocural joint to allow full ankle dorsiflexion.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
August 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Indoor patients Diabetes mellitus type 2
  • Both male and female gender
  • Age between 45-65 years
  • With \& without Peripheral Neuropathy

Exclusion Criteria

  • Any neurological impairment Patients with Foot Ulcer / Amputation
  • History of Surgical procedure of Lower Limb
  • Trauma/ recent fracture of lower limb
  • Patients with severe retinopathy
  • Congenital Foot Deformity
  • Osteoarthritis of Ankle joint

Outcomes

Primary Outcomes

Douleur Neuropathique 4 Questionnaire DN4

Time Frame: baseline to 6th week

Screening tool used to assess the diabetic neuropathic pain, it has 10 items questioned under 4 titles including examination of allodynia and hyperalgesia. DN4 scores ≥ 4 are accepted as positive for the diagnosis of neuropathic pain. assessment will be done at baseline, 3rd and 6th week.

Spirit Level Application

Time Frame: baseline to 6th week

Smartphone application installed on android used to measure range of motion available at ankle joint. The concurrent validity of the Spirit Level Plus application is excellent. assessment will be done at baseline, 3rd and 6th week.

Foot Posture Index (FPI-6)

Time Frame: baseline to 6th week

FPI is used to assess the posture of foot in order to check the area of overpressure due to imbalance in foot position. It consists of 6 items, each item is scored from -2 to +2 using a 5 point scale. The negative score shows more supinated foot and positive number represents pronated foot posture.assessment will be done at baseline, 3rd and 6th week.

Study Sites (1)

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