- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Cairo, Ägypten
- Cairo University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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assessment of upper limb function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P.T.REC/012/006461
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