- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07729800
Effects of Reflex Mediated Core Stability Exercise on Sensory Processing Skills and Gross Motor Function
Effects of Reflex Mediated Core Stability Exercise on Sensory Processing Skills and Gross Motor Function in Children With Cerebral Palsy
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Reflex-mediated core stabilization, also known as dynamic neuromuscular stabilization (DNS). Dynamic Neuromuscular Stabilization (DNS) is a rehabilitation approach based on developmental kinesiology, which observes infant motor behavior from birth to walking. Proposed by Pavel Kolar, it emphasizes posture, breathing patterns, and joint centration, focusing on core stability provided by muscles such as the diaphragm, transverse abdominis, and multifidus. DNS aims to improve muscle strength and endurance by enhancing neuromuscular coordination and integrating the spinal stabilization system. Cerebral Palsy (CP) is a neurodevelopmental disorder affecting posture and mobility due to non-progressive brain lesions, often presenting with abnormal muscle tone, weakness, poor trunk control, and sensory, perceptual, communication, and cognitive issues. Sensory-processing disorders are frequently observed in children with CP. While traditional core stability exercises and sensory integration therapies have shown benefits, this study aims to specifically investigate the comprehensive impact of reflex-mediated core stability exercises (DNS) on both sensory processing skills and overall gross motor function in children with CP.
The study design will be Randomized Controlled Trial, conducted over 10 months at Sehat Medical Complex in Lahore. A total of 26 participants, with 13 in each group, will be recruited using non-probability convenient sampling. Inclusion criteria include children aged 4-12 years diagnosed with spastic-type CP (diplegic) classified within GMFCS Levels III-V who can follow simple verbal instructions, and whose legal guardian provides informed consent. Exclusion criteria encompass severe cognitive impairment, severe muscle contracture >10 degrees or bone deformity, and significant communication deficits. Data will be collected using the Sensory Profiling (SP) and Gross Motor Function Measure-88 (GMFM-88) tools. The experimental Group A will receive 30 minutes of reflex-mediated core stabilization exercises five times weekly, followed by 20 minutes of conventional therapy for 8 weeks. Group B, the control group, will receive conventional therapy. The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study. Data will be analyzed through SPSS version 27.0
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Lahore, Pakistan
- Sehat Medical Complex Hanjarwal
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Children with both genders.
- Children diagnosed with Cerebral Palsy (CP).
- Children aged between 4-12 years (12).
- Children with spastic-type Cerebral Palsy (diplegic) classified within Gross Motor Function Classification System (GMFCS) Levels III-V.
- Ability to understand and consistently follow simple verbal instructions.
- Informed written consent obtained from the child's legal parent or guardian.
Exclusion Criteria:
- Children with severe cognitive impairment.
- Severe muscle contracture >10 degrees or bone deformity significantly limiting participation in exercises.
- Children with significant Communication Deficits
- Any operational procedure within the last six months
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Reflex mediated core stability exercise
the exercises are progressed over the six weeks and include positions such as:
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The exercises are progressed over the six weeks and include positions such as:
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
|
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Eksperimentell: conventional therapy
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
|
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sensory processing skills
Tidsramme: baseline and after 6 weeks
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Sensory profiling was designed by an occupational therapist.
The questionnaire assessing the sensory processing of children aged 3-10 was filled out by their parents or caregivers.
It consisted of 125 items.
The survey consisted of 14 subsections under 3 main headings.
These main topics were sensory processing, modulation, and emotional behavioral responses.
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baseline and after 6 weeks
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Gross motor function
Tidsramme: baseline and after 6 weeks
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The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age.
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baseline and after 6 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Saifah Ashfaq, dpt, ripah international university
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/RCR&AHS/25/0705
Plan for individuelle deltakerdata (IPD)
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