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Recruiting NCT07827625

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

Conditions: Type 2 Diabetes Mellitus (DM)

Sex: All
Ages: 50 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Ibadat International University, Islamabad

Location: Ibadat International University Islamabad Federal

Summary

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.

Eligibility Criteria

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 (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07827625). StuddyBuddy aggregates publicly available trial information.