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Dynamic Orthotic Garment in Diplegic Cerebral Palsy

Effect of Dynamic Orthotic Garment on Foot Pressure Distribution, Postural Control, Functional Performance and Endurance in Spastic Diplegic Cerebral Palsy Children: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05271149
Enrollment
40
Registered
2022-03-08
Start date
2022-02-17
Completion date
2022-05-20
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diplegic Cerebral Palsy

Keywords

Theratog, postural control, cerebral palsy

Brief summary

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)

Detailed description

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)

Interventions

OTHERRoutine Physical Therapy

Routine physical therapy and orthosis

Sponsors

Taibah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* children with CP who have toe-in gait and had grade 1+ to 2 degree of spasticity according to the Modified Ashworth Scale (MAS) \[32\]. In addition to score I and II on Gross Motor Function Classification System (GMFCS) scores \[33\]. As well as the child is required to be able to stand and walk independently.

Exclusion criteria

* Children who have impaired hearing or vision, previous lower limb surgery or Botulinum injections of the lower limb muscles within the preceding 6 months will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Pediatric balance scalebaselineThe 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
Foot pressure distributionbaselineStatic 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.
The trunk control measurement scalebaselineto 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
Trunk Position SensebaselineActive position sense of the trunk was assessed using a digital goniometer.

Secondary

MeasureTime frameDescription
Six-minute walk test (6-MWT)baselinedistance covered during six minutes will be recorded

Countries

Saudi Arabia

Contacts

Primary ContactHatem Emara
dremara.2050@gmail.com0564156262
Backup ContactEman Sobh
Emansobh2012@gmail.com0540418086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026