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

NCT05922280 | Completed

• 1 other identifier: REC/01398 Amna Qandil
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Foot Mobilizations; ankle range of motion; Diabetic Neuropathy; foot posture Index

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline to 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.

  baseline to 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.

  baseline to 6th week

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

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.

experimental group

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

control group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

dr Akbar Niazi teaching hospital Bhara kaho

Islamabad, Capital, 45400, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Aisha Razzaq, MSPT-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 28, 2023
• Study Start: February 15, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)