Study Aims to Compare the Effect of Robotic-assisted Gait Training and Conventional Treadmill Training on Postural Stability in Ambulatory Children With Cerebral Palsy.

NCT06719271 | Completed DMC

• 1 other identifier: KAIMRC study number RC19/363/R
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore the impact of gait training with a robotic device versus treadmill training on enhancing postural stability and walking capabilities in children with cerebral palsy (CP). The main questions to answer are children with CP who receive Robotic gait training will improve more in their postural stability compared with children with CP who received gait training on Treadmill? Are children with CP who receive Robotic gait training will improve more in their gross motor functions compared with children with CP who received gait training on Treadmill Are children with CP who receive Robotic gait training will improve more in their walking distance compared with children with CP who received gait training on Treadmill? Researchers will compare Group A to Group B to see if Robotic gait training has more effect on their outcomes than treadmill. Participants will be randomly allocated to one of two group and will receive gait training for 3 times per week for eight weeks. Outcome measures will be assessed in the base line before starting intervention and after completing intervention. Study Design A randomized control trial (RCT) Participants and Recruitment The trial will be conducted in Pediatric Out-Patient Rehabilitation Services (Clinic 750) at king Abdullah Specialized Children Hospital (KASCH), National Guard Hospital (NGH) in Riyadh, Saudi Arabia. The study populations are ambulatory children who have been diagnosed to have Spastic CP and who are referred and treated in rehabilitation department at KASCH in NGH in Riyadh. Recruitment will be through their medical record number. Inclusion Criteria are Spastic CP diagnosed from a pediatrician's (Neurology clinic) to have Diplegia, Hemiplegia, or Quadriparesis, Both gender with their age ranged from 5-14 years, independently able to stand and walk or walk with assistance, GMFCS Level I and II, with walking limitations, but able to ambulate without the gait device for most distances and with GMFCS Level III, who have a greater degree of walking limitation and able to use wheelchairs or walkers for short to long distances, Ability to follow instructions, Ability to accurately signal pain and discomfort using verbal or non-verbal signals, Ability to be participated in \> 45 minutes of active Physical Therapy treatment, Hip's and knee's passive range of motion (ROM) within the minimum range requirement for robotic device (≤10° for hip and knee flexion contracture). Exclusion Criteria are Botox injection in lower limb during the last 6 months, Surgical intervention in lower limb within a 1-year period prior to the examination date (including tendon release, muscle lengthening and bone surgery), Active drug for resisting epilepsy, Anatomical leg length differences larger than 2 cm (due to the limitations of robotic device), Bone-articular instability (joint dislocation), Fixed joint contractures; bone and joint deformities of lower extremities, Baclofen therapy by using an implanted infusion pump, Inhibiting casts for lower limb during 6 months prior to the program, Significant visual and hearing loss, Skin inflammation and open skin lesions around the lower limb or trunk, Any significant impairments in endurance due to limitation in cardiovascular system based on the patient's history, Cognition (higher mental functions) disorders resulted in lack of patient cooperation, Lack of consent from the parent or guardian. Procedure We will send the invitation letter to the parents of participants. If interested, we will provide their parents with the informed consent (written). We will obtain the Assent from children who are unable to provide independent consent. Then, the participants will complete a basic screening session. If the participant met the eligibility criteria of the screening, he/ she will have a robotic device fitting assessment session to confirm there are no concerns with the participation in the study and to use the robotic device. If the participant met these the fitting criteria, the therapist would review the findings and will confirm (with the family) whether the child is eligible for the study based on their findings. The participants will be divided randomly to enter on of the two treatment groups (robotic or treadmill). Each participant will have a baseline assessment during the first two weeks prior to the beginning of the treatment, treatment program for eight weeks, and post treatment assessment at the last two weeks after completing the program. The duration of the whole program is twelve weeks. All participants will be assessed for their balance and walking parameters.

Conditions

CP (Cerebral Palsy); Robotic Exoskeleton; Treadmill Locomotor-based Training; Postural Stability

Keywords

Robotic Assited Gait Training; postural stability; CP

Outcome Measures

Primary Outcomes (1)

• Postural Stability using Computerized Dynamic Posturography (CDP)

  Outcome measure performed at baseline (within 1-2 weeks before starting the intervention) and after ending the intervention (within 1-2 weeks after completing the intervention)

Secondary Outcomes (1)

• Change in gross motor functions measured by GMFM-88

  Outcome measure performed at baseline (within 1-2 weeks before starting the intervention) and after ending the intervention (within 1-2 weeks after completing the intervention)

Other Outcomes (1)

• Change in Walking Distance Measured by the 6-Minute Walk Test (6MWT)

  Outcome measure performed at baseline (within 1-2 weeks before starting the intervention) and after ending the intervention (within 1-2 weeks after completing the intervention)

Study Arms (2)

Robotic assisted gait training: participants in this group with receive gait training on the Lokomat

ACTIVE COMPARATOR

Device: Participants this group will receive gait training in robotic assisted gait training (RAGT) three times per week for eight weeks

Body Weight Supported Treadmill Training: participants in this group receive training on Treadmill

ACTIVE COMPARATOR

Device: Body Weight Supported Treadmill Training

Interventions

Participants this group will receive gait training in robotic assisted gait training (RAGT) three times per week for eight weeks DEVICE

Robotic Assited Gait Training is a device used to train children with CP how to walk in effective manner by connecting their body to the harness, robotic devices that attached to the electronic treadmill

Robotic assisted gait training: participants in this group with receive gait training on the Lokomat

Body Weight Supported Treadmill Training DEVICE

Participants in this group will receive gait training on conventional treadmill three times per week for eight weeks

Body Weight Supported Treadmill Training: participants in this group receive training on Treadmill

Eligibility Criteria

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

You may qualify if:

• Spastic CP diagnosed from a pediatrician's (Neurology clinic) to have Diaplegia, Diaparesis, Hemiplegia, Hemiparesis, or Quadriparesis.
• Both gender with their age ranged from 5-14 years.
• Independently able to stand and walk or walk with assistance.
• GMFCS Level I and II, with walking limitations, but able to ambulate without the gait device for most distances and with GMFCS Level III, who have a greater degree of walking limitation and able to use wheelchairs or walkers for short to long distances.
• Ability to follow instructions.
• Ability to accurately signal pain and discomfort using verbal or non-verbal signals.
• Ability to be participated in \> 45 minutes of active Physical Therapy treatment.
• Hip's and knee's passive range of motion (ROM) within the minimum range requirement for Lokomat (≤10° for hip and knee flexion contracture).

You may not qualify if:

• Botox injection in lower limb during the last 6 months.
• Surgical intervention in lower limb within a 1-year period prior to the examination date (including tendon release, muscle lengthening and bone surgery).
• Active drug for resisting epilepsy.
• Anatomical leg length differences larger than 2 cm (due to the limitations of Lokomat system).
• Bone-articular instability (joint dislocation).
• Fixed joint contractures; bone and joint deformities of lower extremities.
• Baclofen therapy by using an implanted infusion pump.
• Inhibiting casts for lower limb during 6 months prior to the program.
• Significant visual and hearing loss.
• Skin inflammation and open skin lesions around the lower limb or trunk.
• Any significant impairments in endurance due to limitation in cardiovascular system based on the patient's history.
• Cognition (higher mental functions) disorders resulted in lack of patient cooperation.
• Lack of consent from the parent or guardian.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Rehabilitation Department, Physiotherapy Outpatient Clinic 750 at King Abdullah Specialized Children Hospital, Ministry of National Guard Health Affair, Riyadh, Saudi Arabia.

Riyadh, Saudi Arabia

Location

Related Publications (1)

• Aljosh M, Algabbani MF, Fagehi JM, Bawazeer M, Almohiza MA, Albishi AM, Alhusaini AA. Robotic versus treadmill training: Postural stability in ambulatory CP: RCT study. Pediatr Int. 2025 Jan-Dec;67(1):e70214. doi: 10.1111/ped.70214.

  PMID: 41045011 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Physical Therapist working in Pediatric Outpatient Area in Physical Therapy Rehabilitation Department, at King Abdullah Specialized Children Hospital (KASCH), Ministry of National Guard Health Affair (MNGHA) Riyadh city Saudi Arabia

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 5, 2024
• Study Start: September 25, 2021
• Primary Completion: August 2, 2022
• Study Completion: October 21, 2022
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

SA (1)