Robot Assisted Gait Training In Children With Cerebral Palsy

The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial

Cerebral Palsy (CP) is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. CP primarily affects body movement and muscle coordination. Robot assisted gait training (RAGT) is considered to be a promising approach for improving gait related gross motor function of children and youth with CP.

There is weak and inconsistent evidence regarding the use of RAGT for children with gait disorders. Further research is required with increased numbers and with relevant outcome measures to both confirm the effectiveness and clarify training schedules.

The aim of this research project is to investigate the effectiveness of robot assisted gait training on improvements of functional gait parameters in children with cerebral palsy.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Physical Therapy; Motor Skills Disorders; Robotic Rehabilitation
• Intervention / Treatment: Device: Robot assisted gait training; Other: Conventional physiotherapy

Detailed Description

Cerebral Palsy (CP) is a disorder of posture and movement due to a defect in the immature brain. There is evidence that locomotor therapy for regaining walking capacity using the principle of enhancing neuroplasticity by task-specific training is effective in the rehabilitation process of patients with central gait disorders. The use of a robotic device assists in achieving and maintaining physiological walking pattern for extended periods of therapy. The use of robotic devices as an alternative treatment to improve the gait function in patients with CP has increased.

This is a prospective, randomized comparative trial (RCT). This study is designed to compare the effectiveness of conventional physical therapy (CPt) and robot assisted gait training (RAGT) on gait related motor skills of children with cerebral palsy.

Children aged 5 to 18 years with GMFCS Level 2-4, bilateral or unilateral spastic CP are accepted into this study. Participants are randomly assigned to receive CPt or RAGT + CPt.

All two intervention groups will receive 2-3 sessions of CPt per week over 6-8 weeks. CPt sessions are individually customized to the needs of the child.

The participants of RAGT + CPt group also receive 15 sessions of RAGT (2-3 times per week with a maximum of 45 minute each).

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06530
    • Ankara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• GMFCS Level 2-4
• Bilateral or unilateral spastic CP
• Able to follow instructions and communicate pain or discomfort
• Have a passive range of motion (ROM) of hips and knees within minimum range requirement for robotic assisted training (hip and knee flexion contracture ≤10°, and knee valgus ≤40°)
• Not having participated in another robotic assisted training regime within the previous 6 months
• Able to participate in a minimum of 30 minutes robotic assisted training session
• Able to commit to attendance of two to three times weekly for 15 sessions (to support the primary efficacy analysis)

Exclusion Criteria:

• Botulinum toxin type A injection within 3 months
• Orthopedic surgery on the lower extremity (muscle surgery within the last 9 months, bone surgery within 12 months)
• Bone fractures, open skin lesions, or circulatory problems
• Vision and hearing impairments that affect participation in robotic assisted training
• Epilepsy resistant to medication
• Cardiopulmonary instability
• Use of a baclofen pump

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group; This group will receive 15 sessions of robot-assisted gait training (two or three times per week with a maximum of 45 minutes each) and conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.	Device: Robot assisted gait training; 15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).; Other: Conventional physiotherapy; individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.
Active Comparator: Conventional physiotherapy (CPt) group; This group will receive conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.	Other: Conventional physiotherapy; individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GMFM-88 D Item	The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. D dimension is for Standing abilities. The score of each dimension is expressed as a percentage of the maximum score. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. It takes between 20-25 minutes to be completed.	baseline, 8 weeks, 14 weeks and 20 weeks
Change in GMFM-88 E Item	The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. E dimension is for Walking, Running & Jumping abilities. The score of each dimension is expressed as a percentage of the maximum score. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. It takes between 20-25 minutes to be completed.	baseline, 8 weeks, 14 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 Minute Walk Test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	baseline, 8 weeks, 14 weeks and 20 weeks
Change in 10 Meter Walk Test	The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.	baseline, 8 weeks, 14 weeks and 20 weeks
Change in Modified Ashworth Scale	The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.	baseline, 8 weeks, 14 weeks and 20 weeks
Change in Goal Attainment Scale (GAS)	The GAS methodology is congruent with the client-centered occupational therapy philosophy because GAS provides a means to identify intervention outcomes that are specifically relevant to individuals and their families.	baseline, 8 weeks, 14 weeks and 20 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module (Parent Form)	The PedsQL 3.0 CP module is questionnaire designed to assess the quality of life in children with cerebral palsy. The 35-item PedsQL 3.0 CP Module encompasses seven scales: (1) Daily Activities (9 items); (2) School Activities (4items); (3) Movement and Balance (5 items); (4) Pain andHurt (4 items); (5) Fatigue (4 items); (6) Eating Activities (5items); and (7) Speech and Communication (4 items). A 5-point response scale is utilized across child self-report for ages 8 to 18 years and parent proxy-report (0=never a problem; 1=almost never a problem;2=sometimes a problem; 3=often a problem; 4=almostalways a problem).	baseline, 8 weeks, 14 weeks and 20 weeks

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Birkan Sonel Tur, Prof, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy, Robot assisted gait training, Gait
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Neurodevelopmental Disorders; Cerebral Palsy; Paralysis; Motor Skills Disorders
• Other Study ID Numbers: İ5-310-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No