Clinical trial NCT05271149: Dynamic Orthotic Garment in Diplegic Cerebral Palsy
Official title: Effect of Dynamic Orthotic Garment on Foot Pressure Distribution, Postural Control, Functional Performance and Endurance in Spastic Diplegic Cerebral Palsy Children: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: Theratog
postural control
cerebral palsy
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Foot pressure distribution
timeFrame: baseline
measure: Foot pressure distribution
timeFrame: Twelve week
measure: The trunk control measurement scale
timeFrame: baseline
measure: The trunk control measurement scale
timeFrame: Twelve week
measure: Trunk Position Sense
timeFrame: baseline
measure: Trunk Position Sense
timeFrame: Twelve weeks
measure: Pediatric balance scale
timeFrame: baseline
measure: Pediatric balance scale
timeFrame: Twelve weeks
Secondary outcomes:
measure: Six-minute walk test (6-MWT)
timeFrame: baseline
measure: Six-minute walk test (6-MWT)
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Taibah University
state: Almadinah Almunawarah
Study officials:
affiliation: Associate professor
name: Hatem Emara, PhD
role: PRINCIPAL_INVESTIGATOR
References: