Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?

Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Terms Of Balance, Spasticity And Functionality In Children With Cerebral Palsy?

A total of 26 patients who were diagnosed with CP [diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Robotics
• Intervention / Treatment: Other: conventional therapy; Other: RoboGait®

Detailed Description

Purpose: This study aimed to investigate the effects of robot-assisted training (RAT) on motor functions, spasticity status, balance and functionality in children with cerebral palsy (CP).

Method: A total of 26 patients who were diagnosed with CP [diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).

Outcome measures: GMFCS was used to evaluate motor functions and Modified Ashworth Scale was used to evaluate spasticity. Paediatric Berg Balance Scale, Paediatric Functional Independence Measure and timed up and go test were used to assess balance and functional status. The evaluations were performed at baseline and after 8 weeks of therapy.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Okan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diplegic CP and who were level 2-5 according to the Gross Motor Function Classification System (GMFCS) were included in the study. Children who presented with any disorder involving the peripheral nervous system or another neurological disorder such as epilepsy were not included.

Exclusion Criteria:

• Patients in whom the dose of their prescribed medication for spasticity was changed during the study period were excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: conventional therapy	Other: conventional therapy; Conventional therapy sessions that were planned by a physiotherapist for the children were conducted by a physiotherapist experienced in paediatrics. The therapy sessions mainly focused on functions such as the regulation of muscle tone, correction of posture, elimination of stiffness, muscle strengthening, balance/coordination training and mobilisation (Figure 2). The sessions were planned to last 40 minutes.
EXPERIMENTAL: RoboGait®; Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).	Other: RoboGait®; The RoboGait®-assisted gait system was used for the robot-assisted gait training. In addition to conventional therapy, 16 robot-assisted gait training sessions were conducted, each lasting 25 minutes for 2 days a week (400 minutes in total). Gait speed was 1.5 km/h in all sessions. Considering conditions such as joint limitations and spasticity, gait training was performed with patients bearing 45% to 75% of their weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMFCS	GMFCS was used to determine the extent and severity of CP in order to identify the inclusion criteria. The 5-level classification system that was developed in 1997 and expanded in 2007 by Palisano et al. was used to classify gross motor functions in patients with CP (7). The expanded Turkish version of GMFCS was prepared by Günel et al. (8). Levels of this classification are outlined below: Level I: Walks without limitations Level II: Walks with limitations Level III: Walks with the use of hand-held mobility equipment Level IV: Self-mobility is limited but can use a powered mobility device Level V: Carried on a manual 'wheelchair' GMFCS levels of children with CP were studied under 5 levels in this study. Children with CP who were level 2 and above were included	5 minute
TUG test	This test measures various components such as gait speed, postural control, functional mobility and balance (12). In the evaluation, a chair with a backrest but no armrests was placed at a 3-m distance from the wall and the children were positioned with hips and knees in 90° flexion. The children were asked to stand up, walk and touch the picture on the wall and then go back and sit down. The activity was shown and explained to the children before starting the test. Then, the children were asked to complete this activity twice. The time taken by the children to stand up from the chair, perform the activity and sit down was noted. The mean of the two test results was used for the analysis. Two children who were level 5 according to GMFCS were not included in this assessment.	10 minute
WeeFIM	WeeFIM was used to evaluate the level of functional skills in children with CP. It consists of 18 items in six domains including sphincter control, self-care, transfer, communication, locomotion, cognition and social interaction. Each item in these domains is scored from 1 to 7, considering whether the child is able to perform the relevant functional task in time with or without requiring a device or assistance. The item is scored 1 point if a child requires total assistance while performing the task and 7 if a child independently performs the task safely and in time. The items are scored from 1 to 7 depending on the requirement for assistance. Therefore, the lowest score is 18 (completely dependent) and the highest score is 126 (completely independent) (11).	20 minute
PBBS	PBBS, a modification of the Berg Balance Scale (BBS), developed for children by Franjoine et al. (10) was used to evaluate the functional balance of children during daily life activities. The scale consists of 14 items that are scored from 0 to 4, with a maximum score of 56 points. In PBBS, the order of the sections in the standard BBS has been rearranged from easy to difficult as a functional sorting, the time standards in the sections related to maintenance of static posture have been reduced considering the paediatric population and the guidance has been simplified (10).	15 minute
Modified Ashworth Scale (MAS).	MAS was used to evaluate the muscle tone of the gastrosoleus, gluteus medius and quadriceps femoris muscles in lower limbs. The children were allowed to rest on the therapy bed for 5 minutes before starting the assessment. The measurements were conducted on bare limbs at the same time of the day on a bed with suitable firmness and width, while the children were lying in the supine position with the upper and lower limbs placed parallel to the torso and in extension as much as possible and the head in middle position without a pillow. Passive range of motion exercises were conducted within 1 second for measurement standardisation purposes in MAS. The children included in the study were evaluated by the same physiotherapist.	15 minute

Collaborators and Investigators

• Sponsor: Okan University
• Investigators: Study Chair: Tülay Çevik Saldıran, PhD, Bitlis Eren University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (ACTUAL): March 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Robotics; Functional status; Cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 13.02.2019-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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