- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07742020
Neurodevelopmental Technique Versus Mirror Therapy in Sub-acute Stroke Patients (NDTVSMT)
Effects of Neurodevelopmental Technique Versus Mirror Therapy on Coordination, Functions and Ambulation in Sub-acute Hemiplegic Stroke Patients
Přehled studie
Postavení
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
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ishaq Ahmed, PHD Ishaq Ahmed, PHD, PHD
- Telefonní číslo: Telephone: 0334 4066 463
- E-mail: ishaq.ahmed@uipt.uol.edu.pk
Studijní záloha kontaktů
- Jméno: Ashfaq Ahmed
- Telefonní číslo: Telephone: 03009449192
- E-mail: ashfaq.ahmad@uipt.uol.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 55150
- Nábor
- University of Lahore Teaching Hospital
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Kontakt:
- Iqra Abdul Jabbar, MSPTN
- Telefonní číslo: 03044218624
- E-mail: ciqra4352@gmail.com
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Kontakt:
- Muhammad Asim, Arif
- Telefonní číslo: 03216597727
- E-mail: asim.arif@uipt.uol.edu.pk
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Vrchní vyšetřovatel:
- Hafiza Sana Ashraf, MS-MSK
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
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
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 |
|---|---|
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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.
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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.
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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.
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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 |
|---|---|---|
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Ambulation
Časové okno: Baseline and Week 12
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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
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Lower Extremity Motor Function
Časové okno: Baseline and Week 12
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Lower extremity motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE).
Unit of Measure:- Total score (0-34)
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Baseline and Week 12
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Lower Limb Coordination
Časové okno: Baseline and Week 12
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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
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Baseline and Week 12
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Spolupracovníci a vyšetřovatelé
Sponzor
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
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Ochrnutí
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Mrtvice
- Hemiplegie
- Terapeutika
- Modality fyzikální terapie
- Rehabilitace
- Terapie zrcadlovým pohybem
Další identifikační čísla studie
- REC-UOL-/507/08/24
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