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NCT Number: NCT05922280

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

dr Akbar Niazi teaching hospital Bhara kaho

Islamabad, Capital, 45400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subtalar and talo-crural mobilization

Other

Traction, Antero Posterior (AP) and Postero Anterior (PA) Maitland Grade III oscillatory mobilizations of 2Hz with 120 oscilations per minute, 3 sets for 5 minutes with 1 min of rest between sets at subtalar and talocrural joint would be performed. The mobilization would be large amplitude rhythmic oscillations from the joint mid into end-range muscle spasm/stiffness (translation taken to tissue resistance). Duration will be 20 minutes with 2 sessions per week, total 12 sessions would be performed on each patient in the total period of 6 weeks.

Patients will be guided to follow self foot care examination given by IWGDF Guidelines.

International Working Group of the Diabetic Foot care guidelines

Other

Patients will continue their usual activities according to International Working Group on Diabetic Foot (IWGDF) guidelines including the measures of inspecting the feet, self- examination for callus, pre-ulcerative signs or deformity. They will be restrict barefoot walking in-door and outdoors. To wash their feet daily with careful drying, to use emollients to prevent dryness and cut their nails straight across. Monitor the foot skin temperature for inflammation, wear orthotic insoles for preventing abundant callus.

Patients will perform active ROM exercises 5 times per week for duration of 30 minutes for 6 weeks:Ankle pumps, Supination and Pronation, Drawing score from 0 to 9, Leg Flexion and Extension

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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