- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07595744
Sensory Walkway and Gait in Children With Diplegic Cerebral Palsy (SWGCP)
Effect of Sensory Walkway on Gait Parameters in Children With Diplegic Cerebral Palsy
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This study will be conducted after approval from the Ethical Committee of the Faculty of Physical Therapy, Cairo University, and will follow the ethical principles of the Declaration of Helsinki. Written informed consent will be obtained from the parents of all participating children.
The intervention involves the use of a structured sensory walkway composed of eight wooden foot boxes filled with different textured materials, including polyester fiberfill, cut plastic straws, foam beads, and kinetic sand. This setup is designed to provide continuous multimodal tactile stimulation during gait training to enhance sensory-motor integration, postural control, and gait performance. Children in the intervention group will perform reciprocal gait training while interacting with the sensory surfaces, accompanied by verbal feedback to facilitate sensory awareness and motor engagement.
Both groups will receive a traditional physical therapy program including stretching exercises, quadruped and kneeling activities, balance training, stepper exercises, and gait training on various surfaces and equipment.
Data will be analyzed using descriptive statistics (mean and standard deviation), and statistical analysis will be performed using IBM SPSS software.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shaymaa Rushdy Mahmoud, lecturer
- Telefonnummer: 0201145050053
- E-post: shaymaa.rushdy@pt.cu.edu.eg
Studiesteder
-
-
Giza Governorate
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Dokki, Giza Governorate, Egypt
- Rekruttering
- outpatient clinic, faculty of physical therapy, Cairo university
-
Ta kontakt med:
- Shaymaa Rushdy Mahmoud, lecturer
- Telefonnummer: 0201145050053
- E-post: shaymaa.rushdy@pt.cu.edu.eg
-
Underetterforsker:
- Shaymaa Rushdy Mahmoud, Lecturer of Physical Therapy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of spastic diplegic cerebral palsy
- Aged between 5 and 7 years
- Classified at level II on the Gross Motor Function Classification System
- Spasticity grade 1 or 1+ according to the Modified Ashworth Scale
- Able to walk independently or with an assistive device without physical assistance
- Able to follow verbal commands
- Abnormal gait pattern
Exclusion Criteria:
- Visual or auditory impairment
- History of lower limb surgery within the past 2 years
- Use of medications affecting muscle tone and/or cognitive function
- Contractures or fixed deformities in upper or lower limbs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Control Group - Conventional Physical Therapy
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
|
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
|
|
Eksperimentell: Study Group - Conventional Physical Therapy plus Sensory Walkway Training
Participants in the study group will receive conventional physical therapy including stretching, strengthening, balance exercises, and gait training.
In addition, they will undergo gait training on a sensory walkway consisting of wooden foot boxes filled with different textured materials to provide tactile stimulation.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
Children will walk through the walkway while immersing their feet and hands in the textured materials and are encouraged to identify and describe textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
|
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
Participants in the study group will receive conventional physical therapy in addition to gait training on a sensory walkway.
The sensory walkway consists of a sequence of wooden foot boxes filled with different textured materials to provide tactile stimulation of the feet during walking.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
This setup enables reciprocal sensory stimulation of upper and lower limbs during gait training.
Children will walk through the walkway in a controlled manner while immersing their feet and hands in the textured materials and are encouraged to identify and describe the textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait Speed
Tidsramme: 3 months
|
Gait speed (m/s) will be assessed using the 10-Meter Walk Test (10MWT).
Participants will walk a 10-meter distance at a self-selected comfortable walking speed.
Time recorded during the test will be used only to calculate gait speed.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Step Width
Tidsramme: 3 months
|
Step width (cm) will be assessed using Kinovea software based on video recordings.
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3 months
|
|
Cadence
Tidsramme: 3 months
|
Cadence (steps/min) will be calculated using gait cycle analysis from Kinovea software
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3 months
|
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Step Time
Tidsramme: 3 months
|
Step time (seconds) will be analyzed using Kinovea software based on video-based gait cycle timing.
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3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
- No:P.T.REC/012/006158
Plan for individuelle deltakerdata (IPD)
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