The Efficacy of a RAGT & BWSTT on Children With CP

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Body weight supported treadmill training; Device: Robotic assisted gait training

• Registration Number: NCT06368180
• Lead Sponsor: King Saud University

Brief 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)

Detailed 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)

Study Timeline

• Study Start: 2020-08-30
• Primary Completion: 2021-02-21
• Study Completion: 2021-03-08
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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) (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body weight support treadmill training group	Body weight supported treadmill training	This group had gait training using while the participant's body weight was supported over the treadmill by the Biodex Unweighting System.
Robotic assisted gait training group	Robotic assisted gait training	This group had gait training using a robotic treadmill training system that uses body weight support belt, and driven gait orthoses (pediatric orthoses) for both legs.

Primary Outcome Measures

Name	Time	Method
Gait spatio-temporal parameters	1 minute	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.

Secondary Outcome Measures

Name	Time	Method
Six-minute walk test (6MWT)	6 minutes	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

Trial Locations

Locations (1)

King Abdu Aziz Medical City; 🇸🇦 Riyadh, Saudi Arabia