The Efficacy of a RAGT & BWSTT on Children With CP

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

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)

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Robotic assisted gait training; Device: Body weight supported treadmill training

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdu Aziz Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic assisted gait training group; 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.	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; Other Names: Body weight supported treadmill training
Active Comparator: Body weight support treadmill training group; This group had gait training using while the participant's body weight was supported over the treadmill by the Biodex Unweighting System.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Adel A Alhusaini, professor, Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Actual): February 21, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Children; Cerebral palsy; Robotic-assisted gait training; Body weight-supported treadmill training; Spatio-temporal gait parameters
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 439106274

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No