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

• ClinicalTrials.gov Identifier: NCT05922280
• Recruitment Status: Completed
• First Posted: June 28, 2023
• Last Update Posted: September 6, 2023
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Tracking Information

• First Submitted Date: May 3, 2023
• First Posted Date: June 28, 2023
• Last Update Posted Date: September 6, 2023
• Actual Study Start Date: February 15, 2023
• Actual Primary Completion Date: July 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2023)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetic Foot

Intervention

• 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.

• 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

Study Arms

• 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
  Intervention: Other: subtalar and talo-crural mobilization
• 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.
  Intervention: Other: International Working Group of the Diabetic Foot care guidelines

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 5, 2023): 41
• Original Estimated Enrollment (submitted: June 27, 2023): 52
• Actual Study Completion Date: August 30, 2023
• Actual Primary Completion Date: July 30, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05922280
• Other Study ID Numbers: REC/01398 Amna Qandil
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Riphah International University
• Original Responsible Party: Same as current
• Current Study Sponsor: Riphah International University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Riphah International University
• Verification Date: September 2023