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Neurodevelopmental Technique Versus Mirror Therapy in Sub-acute Stroke Patients (NDTVSMT)

28. července 2026 aktualizováno: University of Lahore

Effects of Neurodevelopmental Technique Versus Mirror Therapy on Coordination, Functions and Ambulation in Sub-acute Hemiplegic Stroke Patients

As neurodevelopmental technique and mirror therapy had different effects on lower limb coordination, functions and ambulation. Both had proven to be helpful in the stroke patients to gain functional independency. Therefore, there was need to find out the best treatment approach either NDT, mirror therapy or both are equally effective to improve motor functions, coordination and ambulation of lower limb. This study would provide the health professionals the evidence to use best technique among these according to improvement in patients' coordination, function and ambulation.The study will be randomized clinical trial. This study will be conducted at the University of Lahore. A sample size of 40 will be randomly allocated by into two experimentals groups, (20 participants in each group), by the lottery method. All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method. This study will be a single blinded study in which assessor will be blinded.

Přehled studie

Detailní popis

The Neurodevelopmental Technique (NDT), also known as the Bobath concept, is a hands-on treatment approach focusing on normalizing movement patterns and reducing muscle tone abnormalities through guided and facilitated movement. It emphasizes postural control, alignment, and symmetrical movement to enhance motor recovery. Bobath approach works on the different types of movement dysfunctions and is based on the active involvement of the patients so that they can develop motor control. Manual handling is holding the patient at specific proprioceptive points, for example, joint compression and distraction, so that patients can respond actively to perform functions. Manual handling can be of different types and is slowly removed to make the patient independent in motor activities. This type of therapy incorporates improved functional control and independence. Mirror Therapy (MT), on the other hand, involves using a mirror to create a visual illusion of movement in the affected limb by reflecting the movements of the unaffected limb. This approach stimulates the brain's motor cortex and supports cortical reorganization through visual feedback, which may facilitate motor recovery and improve function Screening: Participants, will be referred by the Neuro Physician or Medicine Specialist of University of Lahore Teaching Hospital will be assessed for the eligibility criteria. Patients fulfilled the eligibility criteria will be asked to sign the consent forms before entering them to the study.

Recruitment: All the participants who will meet the criteria and sign the consent form will be recruited into the study.

Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method.

Blinding: This study will be a single blinded study in which assessor will be blinded.

Intervention Routine Physical Therapy The treatment will start by routine physiotherapy (RPT) comprised of stretching and ROM in both experimental groups. In ROM following exercises including; hip (flexion, extension, abduction and adduction), knee (flexion, extension), ankle (plantarflexion, dorsiflexion, inversion, eversion and circumduction) and toe (flexion & extension). Stretching exercises included heel cord, gastrocnemius and hamstring stretch. Each ROM exercises were repeated 10 times with rest gap of 1 minute. Stretching exercises will repeated 5 times in one session and stretch will be held for 10 seconds. Time for RPT will be 20-25 minutes including rest intervals.

Group A: Experimental Group 1 (Neurodevelopmental technique with routine physical therapy) The participants randomly allocated in Group A will receive the neurodevelopmental therapy along with RPT. Exercises in NDT program will be performed in different positions: Supine position (Rotation of the trunk, Bridging, Flexion and extension of the knee and hip, Lowering the affected lower limb from the bed with hip extension and knee flexion, Pushing the wall with both limbs), Prone position (Mobilization of the ankle joint and functional stretching of gastro-soleus and quadriceps), Sitting position (Weight bearing on the affected side, reaching with trunk rotation, knee flexion-extension, Exercises of hip flexion and knee extension and Dorsi flexion of the ankle.), Standing position (standing with bearing weight on both legs, stepping to different directions, rising on toe, one leg standing). Each exercise will be 20 times per set in one session 2 minute rest between each set. The whole treatment session will start by 15 min warm up and end with 5 min cool down, and delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and duration of each session will be of 65 minutes in Group A.

Group B: Experimental Group 2 (Mirror therapy with routine physical therapy) The participants randomly allocated in Group B will receive the mirror therapy. The experimental group will receive an additional 45 min of MT training. The patients will be instructed to remain in sitting position with a mirror (60 cm × 90 cm) will be positioned between the affected and healthy legs perpendicular to the subject's mid line. During the Mirror therapy, the reflecting side of the mirror will adjust to the non-affected leg and patients will be instructed to look at the reflection of the unaffected leg in the mirror as if it will the affected leg and perform bilateral symmetrical movements as much as possible. The practices will consist of heel raises (not holding on & sustained both separately), side stepping (not holding on & sustained both separately), single leg standing, leg movements i.e hip-knee-ankle flexion, knee extension with ankle dorsiflexion and ankle eversion. Each exercise will be 20 times per set in one session2 minute rest between each set. The whole treatment session will be delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and duration of each session will be of 60-65 minutes in Group B. The whole treatment plan will be performed under strict observation for the familiarization of participants to ensure that each exercise will be performed by using correct technique.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

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 záloha kontaktů

Studijní místa

    • Punjab Province
      • Lahore, Punjab Province, Pákistán, 55150
        • Nábor
        • University of Lahore Teaching Hospital
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Hafiza Sana Ashraf, MS-MSK

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:

Age range between 45 to 65 years

  • Both genders
  • Sub-acute stroke hemiplegic cases; clinically stable, fully oriented and conscious.
  • Both ischemic and hemorrhagic patients were be included.
  • Patients with mini mental status examination (MMSE) (score > 23)

Exclusion Criteria:

  • Patients had recurrent stroke.
  • Any systemic conditions that limit functions such as; cardiac diseases (exertional dyspnea, angina, Myocardial Infarction, Pacemaker) Pulmonary diseases (Asthma, Pulmonary Fibrosis etc.), Diabatic neuropathy, Diabetic foot, Varicose veins etc
  • Other neurological conditions, such as; foot drop, muscular dystrophy, Myasthenia Gravis, Parkinsonism
  • Any visual and hearing problem
  • Any surgical and traumatic history of fractures, dislocations and/or brain injury due to any traumatic events.

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: Experimental: Neurodevelopmental Technique + Routine PT
Participants will receive Neurodevelopmental Technique (NDT) in supine, prone, sitting, and standing positions. Exercises include bridging, trunk rotation, hip/knee/ankle mobilization, bilateral weight bearing, stepping, and toe rise. Each exercise repeated 20 times per set with 2-minute rest between sets. Session duration: 65 minutes, three times per week, for 12 weeks (36 sessions total), in addition to routine physiotherapy.
Participants will perform Neurodevelopmental Technique (NDT) exercises in supine, prone, sitting, and standing positions. Activities include bridging, trunk rotation, hip/knee flexion-extension, ankle mobilization, bilateral weight bearing, stepping, toe rise, and single leg standing. Each exercise is performed 20 times per set with 2-minute rest intervals. Sessions last 65 minutes, three times per week, for 12 weeks (36 sessions), combined with routine physiotherapy.
Aktivní komparátor: Active Comparator: Mirror Therapy + Routine PT
Participants will receive Mirror Therapy using a mirror (60×90 cm) placed midsagittal to reflect the unaffected leg. Bilateral symmetrical lower limb movements include heel raises, side stepping, single leg standing, hip/knee flexion-extension with ankle dorsiflexion, and ankle eversion. Each exercise repeated 20 times per set with 2-minute rest between sets. Session duration: 60-65 minutes, three times per week, for 12 weeks (36 sessions total), in addition to routine physiotherapy.

Patient sits with mirror (60×90 cm) reflecting unaffected leg. Performs bilateral symmetrical movements: heel raises, side stepping, single leg standing, hip/knee flexion-extension with ankle dorsiflexion, ankle eversion.

Each exercise 20× per set, 2 min rest between sets. 60-65 min/session, 3×/week, for 12 weeks (36 sessions).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Ambulation
Časové okno: Baseline and Week 12

Ambulation will be assessed using the Six-Minute Walk Test (6MWT), which measures the distance a participant walks on a flat surface in six minutes.

Unit of Measure:- Meters

Baseline and Week 12
Lower Extremity Motor Function
Časové okno: Baseline and Week 12
Lower extremity motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). Unit of Measure:- Total score (0-34)
Baseline and Week 12
Lower Limb Coordination
Časové okno: Baseline and Week 12
Lower limb coordination will be assessed using the Lower Extremity Motor Coordination Test (LEMOCOT). Unit of Measure:- Number of target touches completed in 20 seconds
Baseline and Week 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Iqra Abdul Jabbar, MSPTN, Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore
  • Vrchní vyšetřovatel: Hafiza Sana Ashraf, MSPT MSK, Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore

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)

8. září 2025

Primární dokončení (Odhadovaný)

30. července 2026

Dokončení studie (Odhadovaný)

15. srpna 2026

Termíny zápisu do studia

První předloženo

11. září 2025

První předloženo, které splnilo kritéria kontroly kvality

28. července 2026

První zveřejněno (Aktuální)

3. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. července 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

I do not want

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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