رادار التجارب AI | ||
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حالة التجربة السريرية NCT06593158 لـ الشلل الدماغي هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam ٤٨ في المنزل عشوائية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT06593158 هي دراسة تدخُّلية لـالشلل الدماغي وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ٢٧ ربيع الأول ١٤٤٦ هـ لتجنيد ٤٨ مشاركًا. يقودها جامعة لوفان، ومن المتوقع اكتمالها بحلول ٢٨ صفر ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٦ ربيع الأول ١٤٤٦ هـ.
الملخص
This study will use a randomized controlled trial design with a longitudinal baseline to assess the effectiveness of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on motor function and the ability to perform daily activities in Vietnamese children with cerebral palsy, specifically through a caregiver-delivered approach. Participants will be randomly assigned to one of two groups: HABIT-I...عرض المزيد
وصف مفصل
Cerebral palsy (CP) is a group of non-progressive early onset neuromotor disorders that affect the developing brain of the fetus or infant. Motor disorders in CP are often accompanied by sensory, perceptual, cognitive, communicative, and behavioural disorders, and secondary musculoskeletal problems. CP is characterized by impairment in gross motor function involving large muscles which perform daily activities such a...عرض المزيد
العنوان الرسمي
Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Young Children With Cerebral Palsy in Vietnam
الحالات الطبية
الشلل الدماغيمعرّفات دراسة أخرى
- Parent-delivered HABIT-ILE
NCT معرّف
تاريخ البدء (فعلي)
2024-09-30
آخر تحديث مُنشور
2024-09-19
تاريخ الاكتمال (المقدر)
2027-08-01
عدد المشاركين المخطط لهم
٤٨
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
HABIT-ILE
Cerebral Palsy
Caregiver -delivered
Intensive therapy
Home rehabilitation
Cerebral Palsy
Caregiver -delivered
Intensive therapy
Home rehabilitation
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطHABIT-ILE at Camp with Caregivers | Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. * The caregivers delivering HABIT-ILE therapy at camp will follow the same principles as the usual HABIT-ILE. The therapy will take place in a rehabilitation center, and caregivers will provide therapy during the sessions, coached by trained supervisors on site
* The intervention day will then take place, lasting for 5 hours with the constant presence of supervisors. This will be divided into two sessions: a 3-hour i...عرض المزيد |
مقارن نشطHABIT-ILE at Home with Caregivers | Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts. * The caregivers delivering HABIT-ILE therapy at home will follow the same principles as the usual HABIT-ILE. The therapy will take place at children's home, caregivers will provide therapy during the sessions, coached by trained supervisors online
* The intervention day will then take place, lasting for 5 hours with the supervisors through online setting. This will be divided into two sessions: a 3-hour intervention...عرض المزيد |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Gross Motor Function Measure -66 (GMFM- 66) | The GMFM-66 is a 66-item scale that is divided into five aspects of gross motor function: lying and rolling, sitting, crawling, and kneeling, standing, and walking, running, and jumping. All items are arranged in order of difficulty and have a common unit of change from 0 to 100 | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
Melbourne Assessment 2 | \- The Melbourne Assessment 2 (MA2) is a reliable and valid tool used to assess upper limb movement quality in children aged 2.5 to 15 with neurological impairments. It evaluates four key areas: range of motion, accuracy of reaching and placement, dexterity of grasp, release, and manipulation, and fluency of movement. The 14-item test involves children reaching for, grasping, releasing, and manipulating simple objects while their performance is video recorded for later scoring. | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
ACTIVLIM-CP-WA questionnaire | ACTIVLIM-CP-WA questionnaire measures global performance of daily life activities in children with cerebral palsy (CP). The ACTIVLIM-CP-WA was built on the parents' perception and involves 31 items covering the domain of self-care, mobility and domestic life of the International Classification of Functioning, Disability and Health, Child, and Youth version (ICF-CY). The 31 items of the ACTIVLIM-CP-WA include 21 items for preschoolers (2 to 6 years), 23 items for children aging 6 to 12 years and 19 items for teens (12 to 19 years). Parents are instructed to estimate their child's difficulty in performing the activities related to the age of the child, as mentioned in the questionnaire, on three-level responses: Impossible (the child is unable to perform the activity alone), Difficult (the child is able to perform the activity alone, but experiences some difficulties), Easy (the child is able to perform the activity alone, without any difficulty). | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
Paediatric Evaluation of Disability Inventory (PEDI) | PEDI is an interview-based tool that assesses functional performance in children. It is divided into three parts. In part I, this tool assesses in Functional kills of children with some domains such as: Self Care, Mobility, Social Function. Each domain evaluates specific tasks including feeding, dressing, walking, and communicating with others. It is scored on a four-point scale: 0 - unable, 1 - capable. In part II and III, this tool assesses in Caregiver Assistance with some domain such as: Self-Care, Mobility, Social Function. Using a 5-point scale: 5 - independence, 4 - supervision, 3 - average assistance, 2 - minimal assistance, 1 - maximum assistance, 0 - complete assistance. | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
The Canadian Occupational Performance Measure (COPM) | COPM is a client-centred outcome measure that allows individuals to identify and prioritize daily issues that limit their participation in everyday life. The measure focuses on the performance of activities in all areas of life, including self-care, leisure, and productivity to identify and prioritize daily issues that limit their participation in everyday life. 5 of the most important goals are then further assessed using a 10-point scale for performance and satisfaction. | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
WHOQOL-BREF | WHOQOL-BREF is a self-administered questionnaire that includes 26 questions about individuals' perceptions of their health and mental state in the two weeks prior. Answers to the questions are scored on a 1-5 Likert scale, where 1 represents "disagree" or "strongly disagree" and 5 represents "strongly agree" or "extremely agree". WHOQOL-BREF consists of four domains, each with specific aspects: physical health, psychological, social relationships, environment. | Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل
العمر الأدنى للدراسة
2 Years
الجنس المؤهل
الكل
- Diagnosis: Cerebral palsy
- Type of Cerebral palsy: Bilateral cerebral palsy
- Level of gross motor function: level II to IV of GMFCS E& R
- Level of manual ability: level I to IV of mini- MACS
- Environmental factors: Having caregiver support during the study (availability of a caregiver for 5h per day during two weeks of therapy)
- Age of children: 2 to 6 years old
- The child has uncontrolled seizures.
- The child has visual impairment that could interfere with the assessment and treatment.
- The child has severe cognitive problems, unable to understand or be interested in simple games
- Other intensive therapy or surgery/medical intervention that could interfere with study results in the past 6 months and during the study period (e.g. botulinum toxin, etc).
جهة اتصال مركزية للدراسة
جهة اتصال: Yannick Bleyenheuft, Phd, Prof, +324869 99 11, [email protected]
جهة اتصال: Doan MN Nguyen, Phd, +84 392332846, [email protected]
لا توجد بيانات موقع.