The Efficacy of a RAGT & BWSTT on Children With CP

NCT06368180 | Completed

• 1 other identifier: 439106274
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Six-minute walk test (6MWT)

  6 minutes

Study Arms (2)

Robotic assisted gait training group

EXPERIMENTAL

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

Body weight support treadmill training group

ACTIVE COMPARATOR

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

Interventions

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

Robotic assisted gait training group

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.

Body weight support treadmill training group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Abdu Aziz Medical City

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adel A Alhusaini, professor

  Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Robotic-assisted gait training Body weight-supported treadmill training

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: August 30, 2020
• Primary Completion: February 21, 2021
• Study Completion: March 8, 2021
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

SA (1)