Dynamic Orthotic Garment in Diplegic Cerebral Palsy

Diplegic Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271149
• Other study ID #: Theratog
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: February 2022
• Source: Taibah University
• Contact: Hatem Emara
• Phone: 0564156262
• Email: dremara.2050[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 20, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

Other:
• Routine Physical Therapy
Routine physical therapy and orthosis

Locations

Country	Name	City	State
Saudi Arabia	Taibah University	Medina	Almadinah Almunawarah

Sponsors (1)

Lead Sponsor	Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Trunk Position Sense	Active position sense of the trunk was assessed using a digital goniometer.	baseline
Primary	Trunk Position Sense	Active position sense of the trunk was assessed using a digital goniometer.	Twelve weeks
Primary	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	baseline
Primary	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
Secondary	Six-minute walk test (6-MWT)	distance covered during six minutes will be recorded	baseline
Secondary	Six-minute walk test (6-MWT)	distance covered during six minutes will be recorded	Twelve weeks