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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
subtalar and talo-crural mobilization
International Working Group of the Diabetic Foot care guidelines
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Foot Mobilizations, ankle range of motion, Diabetic Neuropathy, foot posture Index

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • dr Akbar Niazi teaching hospital Bhara kaho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Spirit Level Application
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)
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.
Douleur Neuropathique 4 Questionnaire DN4
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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2023
Last Updated
September 5, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05922280
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Foot Mobilizations, ankle range of motion, Diabetic Neuropathy, foot posture Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
subtalar and talo-crural mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
International Working Group of the Diabetic Foot care guidelines
Intervention Description
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 Outcome Measure Information:
Title
Spirit Level Application
Description
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.
Time Frame
baseline to 6th week
Title
Foot Posture Index (FPI-6)
Description
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.
Time Frame
baseline to 6th week
Title
Douleur Neuropathique 4 Questionnaire DN4
Description
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.
Time Frame
baseline to 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr Akbar Niazi teaching hospital Bhara kaho
City
Islamabad
State/Province
Capital
ZIP/Postal Code
45400
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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