Clinical trial NCT06368180: The Efficacy of a RAGT & BWSTT on Children With CP
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Children
Cerebral palsy
Robotic-assisted gait training
Body weight-supported treadmill training
Spatio-temporal gait parameters
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Robotic-assisted gait training Body weight-supported treadmill training
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Gait spatio-temporal parameters
timeFrame: 1 minute
Secondary outcomes:
measure: Six-minute walk test (6MWT)
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdu Aziz Medical City
Study officials:
affiliation: Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University
name: Adel A Alhusaini, professor
role: PRINCIPAL_INVESTIGATOR
References: