The Efficacy of a RAGT & BWSTT on Children With CP

Cerebral Palsy Clinical Trial

Official title:

The Efficacy of a Robotic-assisted Gait Training in Comparison to Body Weight Supported Treadmill Training on Spatio-temporal Gait Parameters Among Ambulatory Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368180
• Other study ID #: 439106274
• Status: Completed
• Phase: N/A
• Start date: August 30, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: May 2024
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP)

Description:

Demographic data were collected from patient medical records in the physiotherapy clinic at King Abdullah Specialist Children's Hospital and by completing the screening sheet . There were two intervention groups in this study. The first group received Robotic-assisted Gait Training (RAGT), while the second group received body weight support treadmill training (BWSTT). All participants from both intervention groups performed the home exercise program. All participants received 24 sessions three times per week over 8 weeks. Some participants were absent from some treatment sessions, either because they were suffering from flu, for reasons related to school, or other reasons. These participants were compensated with other sessions. Outcome measurements were assessed by a physiotherapist blinded to the group allocations. A physiotherapist assessed the participants at baseline and after treatment (at the end of 8 weeks)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 8, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children aged from 5 to 14 years with bilateral spastic Cerebral palsy (CP) diagnosed by a pediatrician.

• Gross Motor Function Classifications (GMFCS); levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).

• Able to follow instructions and accurately signal pain and discomfort.

• Hip and knee passive Range of Motion (ROM) within the minimum range requirement for Robotic-assisted Gait Training (RAGT) (= 10° for hip and knee flexion contracture and = 40° for knee valgus).

Exclusion Criteria:

• Botox injection for lower limb within the past 4 to 6 months.

• Surgical intervention for lower limbs within an 8-month period before the examination date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.

• Children using an active drug for resisting epilepsy.

• Anatomical leg length difference greater than 2 centimeters (due to the limitations of the RAGT system).

• Bone-articular instability (joint dislocation).

• Fixed joint contractures (bone and joint deformity).

• Baclofen therapy with the use of an implanted infusion pump.

• Inhibited cast for a lower limb within 6 months of the study.

• Significant amblyopia and hearing loss.

• Skin inflammation and open skin lesion around the limb or trunk.

• Significant impairments in endurance due to a limitation in the cardiovascular system based on the patient's history.

• Maximum child weight is 135 kilograms and maximum height is 2.0 meters.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Robotic assisted gait training
is a robotic treadmill training system that uses body weight support to suspend patients by attaching their legs to robotic legs that help them walk
• Body weight supported treadmill training
The Biodex Unweighting System was used to support the child's body weight, by an adjustable harness placed, over the treadmill.

Locations

Country	Name	City	State
Saudi Arabia	King Abdu Aziz Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait spatio-temporal parameters	The Zebris gait analysis system was used in this study to obtain gait spatio-temporal parameters in children with CP. The Zebris gait analysis system consists of a platform that has a sensing area of 200 × 60 cm.	1 minute
Secondary	Six-minute walk test (6MWT)	The 6MWT is a standardized walking test used to assess walking capacity in ambulatory children with CP. It is valid and reliable for children and adolescents who have CP and are healthy	6 minutes