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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

14. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

56

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Federal
      • Islamabad, Federal, Pákistán, 47000
        • Nábor
        • Ibadat International University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
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.
Aktivní komparátor: 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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Numeric Pain Rating Scale (NPRS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Hafsah Arshad, PhD, Ibadat International University, Islamabad

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. března 2026

Primární dokončení (Odhadovaný)

30. září 2026

Dokončení studie (Odhadovaný)

5. října 2026

Termíny zápisu do studia

První předloženo

14. září 2026

První předloženo, které splnilo kritéria kontroly kvality

14. září 2026

První zveřejněno (Aktuální)

18. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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