- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07935967
Continuous Passive Motion on Upper Limb Spasticity and Hand Function in Children With Hemiplegic Cerebral Palsy (CPMCP)
Effect of Continuous Passive Movement on Upper Limb Spasticity and Hand Function in Children With Hemiplegia
The goal of this clinical trial is to evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity and hand function in children with hemiplegic cerebral palsy.
The main questions it aims to answer are:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Cerebral palsy (CP) is a common underlying factor contributing to motor impairment in children. CP has frequently changed over the years. The most recent definition of CP is a collection of lasting irregularities in the development of movement and body positioning that result in activity restrictions for the affected person (Sadowska et al.,2020).
Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking (DiNardo et al., 2019).
To date, little research examined the effect of Continuous passive motion (CPM) on functional impairment for upper extremity in CP children with hemiplegia. In addition to the economic changes in our society and increase of the cost of physical therapy session push us to investigate the immediate effect of physical therapy techniques and modalities and determine its validity in order to decrease physical therapy period and cost and improve its effectiveness.
Thus, outcomes of this study will be beneficial to determine the effect of CPM may be effective in the treatment of upper extremity in children with hemiplegia.
Statement of the problem:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Purpose of the study:
The Purpose of the study was:
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To evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity in children with hemiplegic cerebral palsy.
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To evaluate hand function in children with hemiplegic cerebral palsy. The selected subjects will be divided randomly by sealed envelopes into two groups of equal number; thirty children for each group. Participants received 1 hour and 30 minutes per day, 3 days/week for 3 month.
- Study group :
Children of this group will receive specially designed physical therapy program and occupational therapy program in addition to continuous passive movement for the affected upper limb.
-control group : Children of this group will receive only specially designed physical therapy program and occupational therapy program.
Inclusive criteria:
The subjects will be included if:
- Their age will be ranged from 9-12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Eman Fathy Mohamed, Doctoral Degree
- Telefonnummer: +201124424650
- E-Mail: doctoreman.fathy123@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Gehan Hassan El-Meniawy, Professor
- Telefonnummer: +201111801114
- E-Mail: ggelmeniawy@Gmail.com
Studienorte
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Giza, Ägypten
- Faculty of physical therapy Dokki,Giza Egypt
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- The subjects will be included if:
- Their age will be ranged from 9 -12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Exclusion Criteria:
- The subjects will be excluded if they:
- fixed deformities in the spine and/or upper extremities or suffering from Seizures.
- visual nor auditory problems.
- perceptual or cognitive problems.
- injected by BOTOX in deltoid or biceps brachii muscles at the last 6 months
- have surgical interference in upper limbs and/or spine at the last year.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: study group
-Study group: Children will receive specially designed physical therapy program + occupational therapy program in addition to continuous passive movement (CPM) for the affected upper limb. 1.5 hours/day, 3 days/week for 3 months. |
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Aktiver Komparator: Control group
Children will receive only the specially designed physical therapy program + occupational therapy program 1.5 hours/day, 3 days/week for 3 months. |
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hand functions
Zeitfenster: 45-60 minutes
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Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition |
45-60 minutes
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Spasticity of upper limb
Zeitfenster: 10 minutes
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Spasticity will be assessed using electromyographic apparatus (H/M ratio ) |
10 minutes
|
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strength of biceps and deltoid
Zeitfenster: 15 minutes
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Lafayette (hand held dynamometer) |
15 minutes
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Eman Fathy Mohamed, dectoral degree, El salam university
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
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
Schlüsselwörter
Andere Studien-ID-Nummern
- P.T.REC/012/005697
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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