Dynamic Orthotic Garment in Diplegic Cerebral Palsy

NCT05271149 | Unknown

• 1 other identifier: Theratog
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Diplegic Cerebral Palsy

Keywords

Theratog; postural control; cerebral palsy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• Trunk Position Sense

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

  baseline

• Trunk Position Sense

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

  Twelve weeks

• 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

• 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 Outcomes (2)

• Six-minute walk test (6-MWT)

  baseline

• Six-minute walk test (6-MWT)

  Twelve weeks

Study Arms (2)

Control group

OTHER

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

Other: Routine Physical Therapy

study group

EXPERIMENTAL

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

Other: Routine Physical Therapy

Interventions

Routine Physical Therapy OTHER

Routine physical therapy and orthosis

Also known as: Experimental: Intervention group

Control group; study group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Taibah University

Madinah, Almadinah Almunawarah, Saudi Arabia

RECRUITING

Related Publications (1)

• Emara HA, Al-Johany AH, Khaled OA, Al-Shenqiti AM, Ali ARH, Aljohani MM, Sobh E. Effect of the Dynamic Orthotic Garment on Postural Control, and Endurance in Children with Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial. J Multidiscip Healthc. 2024 Jan 30;17:419-428. doi: 10.2147/JMDH.S438474. eCollection 2024.

  PMID: 38314010 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hatem Emara, PhD

  Associate professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatem Emara

CONTACT

0564156262; dremara.2050@gmail.com

Eman Sobh

CONTACT

0540418086; Emansobh2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 8, 2022
• Study Start: February 17, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 20, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

SA (1)