- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Cairo, Egyiptom
- Cairo University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Kísérleti: 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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Aktív összehasonlító: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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assessment of upper limb function
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- P.T.REC/012/006461
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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