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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06368180
Enrollment
40
Registered
2024-04-16
Start date
2020-08-30
Completion date
2021-03-08
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Children, Cerebral palsy, Robotic-assisted gait training, Body weight-supported treadmill training, Spatio-temporal gait parameters

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)

Interventions

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

The Biodex Unweighting System was used to support the child's body weight, by an adjustable harness placed, over the treadmill.

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Robotic-assisted gait training Body weight-supported treadmill training

Eligibility

Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait spatio-temporal parameters1 minuteThe 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

MeasureTime frameDescription
Six-minute walk test (6MWT)6 minutesThe 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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026