Clinical trial NCT05922280: Effect of Subtalar and Talocrural Joint Mobilization on Foot Ranges and Posture in Diabetic Patients
Official title: Effect of Subtalar and Talocrural Joint Mobilization on Foot Ranges and Posture in Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Foot Mobilizations
ankle range of motion
Diabetic Neuropathy
foot posture Index
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 41
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spirit Level Application
timeFrame: baseline to 6th week
measure: Foot Posture Index (FPI-6)
timeFrame: baseline to 6th week
measure: Douleur Neuropathique 4 Questionnaire DN4
timeFrame: baseline to 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: dr Akbar Niazi teaching hospital Bhara kaho
state: Capital
Study officials:
affiliation: Riphah International University
name: Aisha Razzaq, MSPT-OMPT
role: PRINCIPAL_INVESTIGATOR
References: