- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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:
-
To evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity in children with hemiplegic cerebral palsy.
-
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Eman Fathy Mohamed, Doctoral Degree
- Telefonnummer: +201124424650
- E-mail: doctoreman.fathy123@gmail.com
Undersøgelse Kontakt Backup
- Navn: Gehan Hassan El-Meniawy, Professor
- Telefonnummer: +201111801114
- E-mail: ggelmeniawy@Gmail.com
Studiesteder
-
-
-
Giza, Egypten
- Faculty of physical therapy Dokki,Giza Egypt
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
|
Aktiv 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. |
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hand functions
Tidsramme: 45-60 minutes
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spasticity of upper limb
Tidsramme: 10 minutes
|
Spasticity will be assessed using electromyographic apparatus (H/M ratio ) |
10 minutes
|
|
strength of biceps and deltoid
Tidsramme: 15 minutes
|
Lafayette (hand held dynamometer) |
15 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Eman Fathy Mohamed, dectoral degree, El salam university
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- P.T.REC/012/005697
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .