- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07654595
Digital Mirror Versus Action Observation Therapy on Upper Limb Function and Grip Strength in Children With Hemiplegia
Statement of problem:
- Does the digital mirror therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does the action observation therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does there is a difference between effect of digital mirror therapy and action observation therapy on upper limb function and grip strength in children with hemiplegia?
Null hypothesis:
there is no effect of digital mirror therapy on upper limb function and grip strength in children with hemiplegia. There is no effect of action observation therapy on upper limb function and grip strength in children with hemiplegia. There is no difference between effect of digital mirror therapy and Action observation therapy on upper limb function and grip strength in children with hemiplegia.
Přehled studie
Postavení
Detailní popis
Subjects:
The study targets the children from both sexes,diagnosed with hemiplegia,Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial, Children will receive intervention type randomly(3 groups), 15 children will receive digital mirror therapy,15 children will receive action observation therapy, 15 children will receive designed occupational therapy program.
Children will be assessed by Gross Motor Function Classification System (GMFCS) and Manual ability classification system (MACS) for inclusion and Quality of upper extremity skill test, Box and Block Test (BBT) and Hand held dynanmometer which reflect clinical improvement in upper limb function and grip strength before and after 3 months of receiving intervention
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Cairo, Egypt
- Cairo University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 1 Diagnosed with unilateral cerebral palsy (hemiplegia). 2- Age range from 6 to 8 years. 3- Can understand verbal commands. 4- Their gross motor classification system (GMFCS) at level II or III. 5- Their manual ability classification system(MACS) at level II or III.
Exclusion Criteria:
1- Any visual problem. 2- Upper limb contracture or fixed deformity. 3- Uncontrolled convulsion. 4- Surgical procedures in upper limbs. 5- Botox injection in the past 6 months.
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: digital mirror therapy
Children are asked to perform movements of the less affected upper limb, in which those movements are captured by a webcam and then instantly transformed into mirror images of the movements presented on the screen over the paralyzed upper limb, and children can simultaneously observe the mirror images of the movements from the front and simultaneously moved the more affected arm/hand as much as possible, imagining the movements on the screen were performed by their more affected limb, same exercises as designed occupational therapy program, for 1 hour, one session per day , 3 days per week for 12weeks.
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Child will be asked to do the same exercises mentioned in the designed occupational therapy program with the less affected upper limb and the web cam camera will record the movement, instantly transformed into mirror images of the more affected upper limb's movements presented on the screen in front of child.
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Experimentální: action observation therapy
children observed one video clip of a movement or task for 2 min and then practiced executing the same action for 3 min, which the two phases will be applied one time for each exercises, same exercises as designed occupational therapy program
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the child will be offered to tablet screen put in front of him 50 centimeters away, time for each video will last for 2 min.
Then, the child will be asked to repeat the observed action in the best possible way.
All the activities included in the designed occupational therapy program will be observed and imitated.
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Aktivní komparátor: designed occupational therapy program
Active occupational therapy exercises for upper limb training.
The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball .
(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm, thumb to fingers opposition and drawing using tripod grasp for 1 hour, one session per day , 3 days per week for 12weeks.
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Active occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball ,(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm. thumb to fingers opposition and drawing using tripod grasp. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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assessment of upper limb function
Časové okno: 3 months
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The Quality of Upper Extremity Skills Test (QUEST) is one of the most recommended assessment tools.
It aims to evaluate upper limb movement quality and capacity in children with CP, it has four domains dissociated movement, grasp, protective extension and weight bearing.
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3 months
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assessment of manual dextriry
Časové okno: 3 months
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Box and block test (BBT) examines essential components of manual dexterity for developing children, such as grasping, holding, transferring, and releasing
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3 months
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assessment of grip strength
Časové okno: 3 months
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Hydraulic Handheld Dynamometer will be used to assess the maximum isometric strength of the hand muscles, Grip strength is a key predictor of functional ability.
Neuralplasticity, sensorimotor integration, and musculoskeletal function.
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3 months
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Spolupracovníci a vyšetřovatelé
Sponzor
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/006461
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