Mulligan Mobilization With Movement Versus Conventional Physiotherapy on Ankle Range of Motion, Mobility, Pain, and Quality of Life in Patients With Type 2 Diabetes Mellitus

September 14, 2026 updated by: Hafsah Arshad, Ibadat International University, Islamabad

Comparative Effects of Mulligan Mobilization With Movement and Conventional Physiotherapy on Ankle Range of Motion, Mobility, Pain, and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Type 2 Diabetes Mellitus (T2DM) is a major global health concern associated with chronic hyperglycemia, oxidative stress, and accumulation of advanced glycation end-products, which impair connective tissue function and commonly restrict ankle (tibiotalar) mobility. Reduced ankle range of motion, neuropathic pain, and gait instability significantly impair daily activities and quality of life in this population, and reduced ankle mobility is further associated with increased risk of diabetic foot ulceration. Conventional physiotherapy is widely used to address these impairments through exercise, stretching, and strengthening, but may not fully resolve mechanical joint restrictions. Mulligan's Mobilization with Movement (MWM) is a manual therapy technique in which a sustained glide is applied to the ankle during active weight-bearing movement, correcting positional faults and improving dorsiflexion range of motion. While MWM has shown benefit in non-diabetic ankle conditions, its effectiveness relative to conventional physiotherapy in patients with T2DM remains unclear.

This study is a randomized controlled trial comparing the effects of Mulligan Mobilization with Movement (Group A) versus conventional physiotherapy (Group B) on pain intensity, ankle range of motion, functional mobility, and quality of life in adults aged 50-70 years with Type 2 Diabetes Mellitus of more than 5 years' duration. A total of 56 participants will be recruited using non-probability purposive sampling and randomly allocated by coin-toss method into two equal groups of 28. Both groups will receive baseline treatment (hot pack application and gentle active ankle movement) followed by their assigned protocol - Group A receiving MWM (sustained anteroposterior/posteroanterior glide to the distal tibia or fibula during active dorsiflexion or plantarflexion, 3 sets of 10 repetitions) and Group B receiving conventional physiotherapy (active/passive range-of-motion exercises, calf raises, and calf/Achilles stretching) - three sessions per week for six weeks.

Outcomes will be assessed at baseline and following the six-week intervention period. Primary outcome measures include pain intensity (Numeric Pain Rating Scale), ankle range of motion (goniometer), functional mobility (Timed Up and Go test), and quality of life (SF-12 Health Survey). Data will be analyzed using IBM SPSS Statistics version 27, with normality assessed via the Shapiro-Wilk test and within- and between-group comparisons made using parametric or non-parametric tests as appropriate.

This trial is expected to generate direct comparative evidence on whether Mulligan Mobilization with Movement offers superior outcomes to conventional physiotherapy for ankle-related impairments in patients with T2DM, helping physiotherapists select more targeted, evidence-based rehabilitation protocols for this population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 Diabetes Mellitus is characterized by impaired insulin secretion and reduced insulin sensitivity resulting in chronic hyperglycemia. Pakistan ranks among the top ten countries globally for diabetes prevalence, with an estimated 7.5 million affected adults and no national diabetes management strategy. Chronic hyperglycemia drives collagen glycation and accumulation of advanced glycation end-products, causing tendon and joint-capsule stiffness, structural changes in the Achilles tendon and plantar fascia, and loss of ankle dorsiflexion; peripheral neuropathy further impairs proprioception and reinforces ankle hypomobility. Physiotherapy management, by improving available range of motion and normalizing foot and ankle biomechanics during gait, is a proposed conservative approach to these impairments. Mulligan's Mobilization with Movement (MWM) is an interactive manual therapy technique in which a sustained posterior talar glide is applied during active weight-bearing dorsiflexion, correcting talar positional faults and improving dorsiflexion range of motion. Rao and colleagues found that individuals with diabetes mellitus show markedly reduced ankle dorsiflexion compared with non-diabetic controls (peak dorsiflexion of 5.1° versus 11.5°, a roughly 41% reduction, p<0.001) along with greater passive ankle stiffness, supporting the use of a dorsiflexion cutoff to identify patients most likely to benefit from targeted intervention.

Existing literature supports MWM's benefit in non-diabetic ankle conditions (e.g., acute/subacute lateral ankle sprain, chronic stroke) and supports multi-component foot/ankle exercise programs in diabetic populations, but no identified trial has directly compared MWM to conventional physiotherapy specifically in patients with T2DM-related ankle impairment, leaving a clear evidence gap that this trial addresses.

Problem Statement Patients with Type 2 Diabetes Mellitus commonly present with reduced ankle mobility, impaired balance, pain, and decreased quality of life due to diabetes-related musculoskeletal changes. Although conventional physiotherapy is routinely used, there is limited evidence comparing its effectiveness with Mulligan Mobilization with Movement in this population, and MWM's effectiveness in individuals with T2DM remains unclear.

Study Design and Methods This is a randomized controlled trial. Eligible participants are adults aged 50-70 years with Type 2 Diabetes Mellitus of more than 5 years' duration, both male and female, willing to provide informed consent, with pain rated 3-7 on the Numeric Pain Rating Scale and ankle dorsiflexion range of motion ≤10° on goniometric assessment. Individuals with recent lower-limb surgery, fracture or dislocation (<6 months), active diabetic foot ulcer or Charcot foot, inflammatory joint disease, congenital foot deformity, or diagnosed diabetic peripheral neuropathy are excluded. A total of 56 participants, calculated using the OpenEpi Sample Size Calculator based on ankle dorsiflexion range of motion as the primary outcome, will be recruited via non-probability purposive sampling and randomized by coin-toss method into two groups of 28.

Both groups receive baseline treatment (hot pack to the ankle for 10-15 minutes and gentle active ankle movement within pain-free range). Group A then receives MWM: a sustained anteroposterior or posteroanterior glide to the distal tibia/fibula during active dorsiflexion or plantarflexion, 3 sets of 10 repetitions, each repetition held 3-5 seconds, with 30-60 seconds rest between sets, 30-40 minutes per session. Group B receives conventional physiotherapy: active and passive ankle range-of-motion exercises (dorsiflexion, plantarflexion, inversion, eversion), calf raises (10 reps × 3 sets), and calf/Achilles tendon stretching, 30-40 minutes per session, 10-15 repetitions × 2-3 sets. Both groups attend 3 sessions per week for 6 weeks.

Outcome Measures Four outcome domains are assessed at baseline and post-intervention (6 weeks): pain intensity via the Numeric Pain Rating Scale (NPRS, 0-10); ankle range of motion (dorsiflexion, plantarflexion) via goniometer; functional mobility via the Timed Up and Go (TUG) test; and quality of life via the SF-12 Health Survey.

Data Analysis and Ethics Statistical analysis will be carried out using IBM SPSS Statistics version 27. The Shapiro-Wilk test will assess normality. Within-group comparisons will use the paired-samples t-test (normal data) or Wilcoxon signed-rank test (non-normal data); between-group comparisons will use the independent-samples t-test (normal data) or Mann-Whitney U test (non-normal data). A p-value < 0.05 will be considered statistically significant. The trial will be conducted under Research Ethics Review Committee approval, with written informed consent obtained from all participants, voluntary participation, and the right to withdraw at any time without affecting care or academic standing.

Study Type

Interventional

Enrollment (Estimated)

56

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 Contact

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 47000
        • Recruiting
        • Ibadat International University
        • Contact:

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:

  • Patients aged 50-70 years
  • Both male and female
  • Diabetes Mellitus > 5 years' duration
  • Willing to participate and provide informed consent
  • Pain rated between 3-7 on the Numeric Pain Rating Scale (NPRS)
  • Ankle dorsiflexion range of motion ≤10° on goniometric assessment

Exclusion Criteria:

  • History of recent lower-limb surgery, fracture, or dislocation (<6 months)
  • Active diabetic foot ulcer or Charcot foot
  • Any inflammatory joint disease (e.g., rheumatoid arthritis)
  • Congenital foot deformity
  • Diagnosed diabetic peripheral neuropathy

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Baseline: hot pack 10-15 min + gentle active ankle movement. Followed by Mulligan Mobilization with Movement: sustained AP/PA glide to distal tibia/fibula during active dorsiflexion/plantarflexion, 3 sets × 10 reps, each rep held 3-5s, 30-60s rest between sets. 30-40 min/session. 3 sessions/week for 6 weeks.
Other: Experimental
Baseline: hot pack 10-15 min + gentle active ankle movement. Followed by Mulligan Mobilization with Movement: sustained AP/PA glide to distal tibia/fibula during active dorsiflexion/plantarflexion, 3 sets × 10 reps, each rep held 3-5s, 30-60s rest between sets. 30-40 min/session. 3 sessions/week for 6 weeks.
Active Comparator: Group B
Same baseline treatment as Group A. Followed by Conventional Physiotherapy: active/passive ankle ROM exercises (dorsiflexion, plantarflexion, inversion, eversion), calf raises 10×3 sets, calf/Achilles stretching. 30-40 min/session, 10-15 reps × 2-3 sets. 3 sessions/week for 6 weeks.
Other: Control
Same baseline treatment as Group A. Followed by Conventional Physiotherapy: active/passive ankle ROM exercises (dorsiflexion, plantarflexion, inversion, eversion), calf raises 10×3 sets, calf/Achilles stretching. 30-40 min/session, 10-15 reps × 2-3 sets. 3 sessions/week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: assessed at baseline and post-intervention (6 weeks).
0-10 self-reported pain intensity scale
assessed at baseline and post-intervention (6 weeks).
Goniometer Measurement
Time Frame: assessed at baseline and post-intervention (6 weeks).
Dorsiflexion and plantarflexion measured in degrees using a goniometer;
assessed at baseline and post-intervention (6 weeks).
Timed Up and Go (TUG) Test
Time Frame: assessed at baseline and post-intervention (6 weeks).
Time in seconds to rise from a chair, walk 3 meters, turn, and return
assessed at baseline and post-intervention (6 weeks).
Quality of Life - SF-12
Time Frame: assessed at baseline and post-intervention (6 weeks).
12-item self-reported questionnaire assessing physical and mental health-related quality of life
assessed at baseline and post-intervention (6 weeks).

Collaborators and Investigators

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

Sponsor

Ibadat International University, Islamabad

Investigators

  • Principal Investigator: Hafsah Arshad, PhD, Ibadat International University, Islamabad

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)

March 2, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 5, 2026

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIUI/RERC/ADT/2026/02/255

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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