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 RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Robotic assisted gait 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 RAGT, while the second group received 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. We compensated these participants with other ses-sions. 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:

• 1. Children aged from 5 to 14 years with bilateral spastic CP diagnosed by a pediatri-cian.

  2. GMFCS levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).

  3. Able to follow instructions and accurately signal pain and discomfort. 4. Hip and knee passive ROM within the minimum range requirement for RAGT (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ for knee valgus).

Exclusion Criteria:

• 1. Botox injection for lower limb within the past 4 to 6 months. 2. Surgical intervention for lower limbs within an 8-month period before the exami-nation date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.

  3. Children using an active drug for resisting epilepsy. 4. Anatomical leg length difference greater than 2 cm (due to the limitations of the RAGT system).

  5. Bone-articular instability (joint dislocation). 6. Fixed joint contractures (bone and joint deformity). 7. Baclofen therapy with the use of an implanted infusion pump. 8. Inhibited cast for a lower limb within 6 months of the study. 9. Significant amblyopia and hearing loss. 10. Skin inflammation and open skin lesion around the limb or trunk. 11. Significant impairments in endurance due to a limitation in the cardiovascular system based on the patient's history.

  12. Maximum child weight is 135 kg and maximum height is 2.0 m.

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; It 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.	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
Experimental: Body weight support treadmill training; It is a dynamic system that facilitates walking capacity, velocity, endurance, and balance. Body weight is unloaded by a harness system placed over a treadmill.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait spatio-temporal parameters	The zebris win FDM was used in this study to obtain gait spatio-temporal pa-rameters in children with CP. The zebris win FDM 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 (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 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