Effect of Dynamic Orthotic Garment on Foot Pressure Distribution, Postural Control, Functional Performance and Endurance in Spastic Diplegic Cerebral Palsy Children: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Taibah University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pediatric balance scale
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 10 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Control group
conventional physical therapy based on neurodevelopmental techniques, This program will be given for 1 hour, 3 days a week for 12 weeks
Intervention: Routine Physical Therapy (Other)
study group
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
Intervention: Routine Physical Therapy (Other)
Outcomes
Primary Outcomes
Pediatric balance scale
Time Frame: Twelve weeks
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
The trunk control measurement scale
Time Frame: Twelve week
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
Foot pressure distribution
Time Frame: Twelve week
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.
Trunk Position Sense
Time Frame: Twelve weeks
Active position sense of the trunk was assessed using a digital goniometer.
Foot pressure distribution
Time Frame: baseline
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.
The trunk control measurement scale
Time Frame: baseline
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
Trunk Position Sense
Time Frame: baseline
Active position sense of the trunk was assessed using a digital goniometer.
Pediatric balance scale
Time Frame: baseline
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
Secondary Outcomes
- Six-minute walk test (6-MWT)(Twelve weeks)
- Six-minute walk test (6-MWT)(baseline)
Investigators
Hatem Abd Elmohsen Abdel Hamid Emara
Associate professor
Taibah University