AzTrials
AzTrials

Type 2 Diabetes Mellitus (DM)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

A study testing Experimental in people with Type 2 Diabetes Mellitus (DM), run by Ibadat International University, Islamabad at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus (DM)
What is being tested?
Experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePakistan
Study dates
2 Mar 2026to 5 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nazish Jahangir, Master in MSK contact

03125319484

Nazishjehanger@gmail.com

Pakistan1 site, 1 recruiting
  • Ibadat International University

    Islamabad, Federal, 47000

    Hafsah Arshad, PhD*, 03315165234, hafsaharshad@hotmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Experimental, Control
Keywords
Mulligan Mobilization with Movement, ankle range of motion, quality of life, pain
Medical subject headings
Diabetes Mellitus, Type 2, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalOther

    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.

  • ControlOther

    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.

Study groups in NCT07827625
Study groupRoleWhat they receive
Group AExperimentalBaseline: 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.
Receives: Other: Experimental
Group BActive comparatorSame 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

    0-10 self-reported pain intensity scale

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

  2. Goniometer Measurement

    Dorsiflexion and plantarflexion measured in degrees using a goniometer;

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study start2 Mar 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion5 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827625
Sponsor's protocol ID
IIUI/RERC/ADT/2026/02/255
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Type 2 Diabetes Mellitus (DM), run by Ibadat International University, Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nazish Jahangir, Master in MSK (03125319484, Nazishjehanger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: assessed at baseline and post-intervention (6 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in