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

September 5, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Capital
      • Islamabad, Capital, Pakistan, 45400
        • dr Akbar Niazi teaching hospital Bhara kaho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Traction, Antero Posterior (AP) and Postero Anterior (PA) Maitland Grade III oscillatory foot mobilizations. Patients will continue their usual activities according to International Working Group on Diabetic Foot (IWGDF) guidelines including the measures of inspecting the feet, wash and properly wear shoes and perform ankle ROMs
Other: subtalar and talo-crural mobilization

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.
Active Comparator: control group
Patients will continue their usual activities according to International Working Group on Diabetic Foot (IWGDF) guidelines including the measures of inspecting the feet, wash and properly wear shoes and perform ankle ROMs.
Other: International Working Group of the Diabetic Foot care guidelines

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 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.
baseline to 6th week
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.
baseline to 6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Aisha Razzaq, MSPT-OMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01398 Amna Qandil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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