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

NCT07827625 | Recruiting

• 1 other identifier: IIUI/RERC/ADT/2026/02/255
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (DM)

Keywords

Mulligan Mobilization with Movement; ankle range of motion; quality of life; pain

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

  0-10 self-reported pain intensity scale

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

• Goniometer Measurement

  Dorsiflexion and plantarflexion measured in degrees using a goniometer;

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

• Timed Up and Go (TUG) Test

  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

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

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

Study Arms (2)

Group A

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.

Other: Experimental

Group B

ACTIVE COMPARATOR

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

Interventions

Experimental OTHER

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.

Group A

Control OTHER

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.

Group B

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead

Study Sites (1)

Ibadat International University

Islamabad, Federal, 47000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pain

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hafsah Arshad, PhD

  Ibadat International University, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazish Jahangir, Master in MSK

CONTACT

03125319484; Nazishjehanger@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant and therapist will be not be blinded. Outcome assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Parallel-group design in which 56 participants are randomized by coin-toss method into two equal groups (n=28 each), receiving Mulligan Mobilization with Movement or conventional physiotherapy, without crossover.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: March 2, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)