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Dynamic Orthotic Garment in Diplegic Cerebral Palsy

Primary Purpose

Diplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Routine Physical Therapy
Sponsored by
Taibah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diplegic Cerebral Palsy focused on measuring Theratog, postural control, cerebral palsy

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taibah UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

study group

Arm Description

conventional physical therapy based on neurodevelopmental techniques, This program will be given for 1 hour, 3 days a week for 12 weeks

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

Outcomes

Primary Outcome Measures

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.
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.
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
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
Trunk Position Sense
Active position sense of the trunk was assessed using a digital goniometer.
Trunk Position Sense
Active position sense of the trunk was assessed using a digital goniometer.
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
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

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2022
Last Updated
March 5, 2022
Sponsor
Taibah University
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1. Study Identification

Unique Protocol Identification Number
NCT05271149
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
May 17, 2022 (Anticipated)
Study Completion Date
May 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taibah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy
Keywords
Theratog, postural control, cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
conventional physical therapy based on neurodevelopmental techniques, This program will be given for 1 hour, 3 days a week for 12 weeks
Arm Title
study group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Routine Physical Therapy
Other Intervention Name(s)
Experimental: Intervention group
Intervention Description
Routine physical therapy and orthosis
Primary Outcome Measure Information:
Title
Foot pressure distribution
Description
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.
Time Frame
baseline
Title
Foot pressure distribution
Description
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.
Time Frame
Twelve week
Title
The trunk control measurement scale
Description
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
Time Frame
baseline
Title
The trunk control measurement scale
Description
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
Time Frame
Twelve week
Title
Trunk Position Sense
Description
Active position sense of the trunk was assessed using a digital goniometer.
Time Frame
baseline
Title
Trunk Position Sense
Description
Active position sense of the trunk was assessed using a digital goniometer.
Time Frame
Twelve weeks
Title
Pediatric balance scale
Description
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
Time Frame
baseline
Title
Pediatric balance scale
Description
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
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Six-minute walk test (6-MWT)
Description
distance covered during six minutes will be recorded
Time Frame
baseline
Title
Six-minute walk test (6-MWT)
Description
distance covered during six minutes will be recorded
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatem Emara
Phone
0564156262
Email
dremara.2050@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Sobh
Phone
0540418086
Email
Emansobh2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Emara, PhD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taibah University
City
Medina
State/Province
Almadinah Almunawarah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AHMED Aljohani
Phone
0555313167
Email
ahmedjj9@gmail.com

12. IPD Sharing Statement

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Dynamic Orthotic Garment in Diplegic Cerebral Palsy

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