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Completed

NCT Number: NCT06368180

The Efficacy of a RAGT & BWSTT on Children With CP

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)

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Key information

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdu Aziz Medical City

Riyadh, Saudi Arabia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic assisted gait training

Device

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

Device

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

Primary outcomes

  1. Gait spatio-temporal parameters

    Time frame: 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 outcomes

  1. Six-minute walk test (6MWT)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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