- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaymaa Rushdy Mahmoud, lecturer
- Phone Number: 0201145050053
- Email: shaymaa.rushdy@pt.cu.edu.eg
Study Locations
-
-
Giza Governorate
-
Dokki, Giza Governorate, Egypt
- Recruiting
- Outpatient Clinic, Faculty of Physical Therapy, Cairo University
-
Contact:
- Shaymaa Rushdy Mahmoud, lecturer
- Phone Number: 0201145050053
- Email: shaymaa.rushdy@pt.cu.edu.eg
-
Sub-Investigator:
- Shaymaa Rushdy Mahmoud, Lecturer of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Speed
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step Width
Time Frame: 3 months
|
Step width (cm) will be assessed using Kinovea software based on video recordings.
|
3 months
|
|
Cadence
Time Frame: 3 months
|
Cadence (steps/min) will be calculated using gait cycle analysis from Kinovea software
|
3 months
|
|
Step Time
Time Frame: 3 months
|
Step time (seconds) will be analyzed using Kinovea software based on video-based gait cycle timing.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No:P.T.REC/012/006158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spastic Diplegic Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
Ziauddin UniversityCompleted
-
Wroclaw University of Health and Sport SciencesNot yet recruitingSpastic Diplegia Cerebral Palsy | Spastic HemiplegiaPoland
-
Cairo UniversityActive, not recruitingDiplegic Spastic Cerebral PalsyEgypt
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
-
Riphah International UniversityRecruitingCerebral Palsy Spastic DiplegiaPakistan
Clinical Trials on Conventional Physical Therapy Program
-
Cairo UniversityCompleted
-
Ragaee Saeed MahmoudRecruiting
-
South Valley UniversityRecruiting
-
Ankara UniversityCompleted
-
Cairo UniversityRecruiting
-
Cairo UniversityCompleted
-
Kutahya Health Sciences UniversityCompletedKnee OsteoarthritisTurkey
-
Sword Health, SAEmory UniversityCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompleted