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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorIbadat International University, Islamabad

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 50-70 years

Both male and female

Diabetes Mellitus > 5 years' duration

Willing to participate and provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Other intervention

    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.

  • Control

    Other intervention

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Pain Rating Scale (NPRS)

0-10 self-reported pain intensity scale

Time frame
assessed at baseline and post-intervention (6 weeks).
2

Goniometer Measurement

Dorsiflexion and plantarflexion measured in degrees using a goniometer;

Time frame
assessed at baseline and post-intervention (6 weeks).
3

Timed Up and Go (TUG) Test

Time in seconds to rise from a chair, walk 3 meters, turn, and return

Time frame
assessed at baseline and post-intervention (6 weeks).
4

Quality of Life - SF-12

12-item self-reported questionnaire assessing physical and mental health-related quality of life

Time frame
assessed at baseline and post-intervention (6 weeks).

Secondary outcomes

Other outcomes

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