Dynamic Orthotic Garment in Diplegic Cerebral Palsy

Taibah University

Status: Unknown

Conditions: Diplegic Cerebral Palsy

Treatments: Other: Routine Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05271149

Theratog

Details and patient eligibility

About

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)

Full 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)

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Control group

Other group

Description:

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

Treatment:

Other: Routine Physical Therapy

study group

Experimental group

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

Treatment:

Other: Routine Physical Therapy