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This study aims to evaluate the effectiveness of dynamic orthotic garment (Thera togs) on foot pressure distribution, postural control, functional performance and endurance in children with spastic diplegic cerebral palsy (CP). Methods: forty children with spastic diplegic CP, with ages ranging from 8 to 10 years, will be assigned randomly into two groups. The control group will receive the conventional physical therapy, whereas the study group will receive the same program as the control group in addition to Thera togs. Measurement of foot pressure distribution will be performed using a pressure platform, postural control will be evaluated using the trunk control measurement scale Trunk Position Sense pediatric berg balance scale, endurance will be assessed using six-minute walk test (6MWT)
This study aims to evaluate the effectiveness of dynamic orthotic garment (Thera togs) on foot pressure distribution, postural control, functional performance and endurance in children with spastic diplegic cerebral palsy (CP). Methods: forty children with spastic diplegic CP, with ages ranging from 8 to 10 years, will be assigned randomly into two groups. The control group will receive the conventional physical therapy, whereas the study group will receive the same program as the control group in addition to Thera togs. Measurement of foot pressure distribution will be performed using a pressure platform, postural control will be evaluated using the trunk control measurement scale ,Trunk Position Sense , pediatric berg balance scale, endurance will be assessed using six-minute walk test (6MWT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | conventional physical therapy based on neurodevelopmental techniques, This program will be given for 1 hour, 3 days a week for 12 weeks |
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| study group | Experimental | conventional physical therapy and orthosis (Thera togs) : the child will wear the orthosis for twelve weeks, from 8 to 10 hours a day, during daily-life activities. The child's guardian (mother) will be trained and will receive a DVD recording, with a step-by-step demonstration on the fitting of TheraTogs® in the child. Markings were made in TheraTogs® to facilitate and improve fitting. All necessary support will be offered, with weekly monitoring in person to control the fitting of the orthosis, as well as for possible questions or clarifications.in addition to conventional physical therapy as the control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Physical Therapy | Other | Routine physical therapy and orthosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Foot pressure distribution | Static and dynamic planter pressure measurements to measure peak and mean plantar pressure for each sub-region of the foot (forefoot, mid-foot and rear-foot) expressed in kPa. | baseline |
| Foot pressure distribution | Static and dynamic planter pressure measurements to measure peak and mean plantar pressure for each sub-region of the foot (forefoot, mid-foot and rear-foot) expressed in kPa. | Twelve week |
| The trunk control measurement scale | to assess the static and dynamic components of trunk control.The minimum score is 1 and the maximum scor is 58.Higher score means better outcome | baseline |
| The trunk control measurement scale | to assess the static and dynamic components of trunk control .The minimum score is 1 and the maximum scor is 58.Higher score means better outcome | Twelve week |
| Trunk Position Sense | Active position sense of the trunk was assessed using a digital goniometer. | baseline |
| Trunk Position Sense | Active position sense of the trunk was assessed using a digital goniometer. | Twelve weeks |
| Pediatric balance scale | The Pediatric balance scale, used to determine the dynamic balancing abilities of children with cerebral palsy, shows an excellent inter-rater reliability.The minimum score is 1 and the maximum score is 56.Higher score means better outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test (6-MWT) | distance covered during six minutes will be recorded | baseline |
| Six-minute walk test (6-MWT) | distance covered during six minutes will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hatem Emara | Contact | 0564156262 | dremara.2050@gmail.com | |
| Eman Sobh | Contact | 0540418086 | Emansobh2012@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hatem Emara, PhD | Associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taibah University | Recruiting | Madinah | Almadinah Almunawarah | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38314010 | Derived | Emara HA, Al-Johany AH, Khaled OA, Al-Shenqiti AM, Ali ARH, Aljohani MM, Sobh E. Effect of the Dynamic Orthotic Garment on Postural Control, and Endurance in Children with Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial. J Multidiscip Healthc. 2024 Jan 30;17:419-428. doi: 10.2147/JMDH.S438474. eCollection 2024. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| baseline |
| Pediatric balance scale | The Pediatric balance scale, used to determine the dynamic balancing abilities of children with cerebral palsy, shows an excellent inter-rater reliability.The minimum score is 1 and the maximum score is 56.Higher score means better outcome | Twelve weeks |
| Twelve weeks |