- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ishaq Ahmed, PHD Ishaq Ahmed, PHD, PHD
- Номер телефона: Telephone: 0334 4066 463
- Электронная почта: ishaq.ahmed@uipt.uol.edu.pk
Учебное резервное копирование контактов
- Имя: Ashfaq Ahmed
- Номер телефона: Telephone: 03009449192
- Электронная почта: ashfaq.ahmad@uipt.uol.edu.pk
Места учебы
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Punjab Province
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Lahore, Punjab Province, Пакистан, 55150
- Рекрутинг
- University of Lahore Teaching Hospital
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Контакт:
- Iqra Abdul Jabbar, MSPTN
- Номер телефона: 03044218624
- Электронная почта: ciqra4352@gmail.com
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Контакт:
- Muhammad Asim, Arif
- Номер телефона: 03216597727
- Электронная почта: asim.arif@uipt.uol.edu.pk
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Главный следователь:
- Hafiza Sana Ashraf, MS-MSK
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
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Активный компаратор: 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). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Ambulation
Временное ограничение: 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
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Lower Extremity Motor Function
Временное ограничение: 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
|
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Lower Limb Coordination
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Iqra Abdul Jabbar, MSPTN, Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore
- Главный следователь: Hafiza Sana Ashraf, MSPT MSK, Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Цереброваскулярные расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Паралич
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Инсульт
- Гемиплегия
- Терапия
- Физиотерапия
- Реабилитация
- Зеркальная движенная терапия
Другие идентификационные номера исследования
- REC-UOL-/507/08/24
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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