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

Primary Purpose

Cerebral Palsy, Robotics

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional therapy
RoboGait®
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Robotics, Functional status

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Okan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional therapy

RoboGait®

Arm Description

conventional therapy

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).

Outcomes

Primary Outcome Measures

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
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.
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2020
Last Updated
March 1, 2021
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04781101
Brief Title
Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?
Official Title
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Robotics
Keywords
Cerebral palsy, Robotics, Functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional therapy
Arm Type
Experimental
Arm Description
conventional therapy
Arm Title
RoboGait®
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
RoboGait®
Intervention Description
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.
Primary Outcome Measure Information:
Title
GMFCS
Description
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
Time Frame
5 minute
Title
TUG test
Description
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.
Time Frame
10 minute
Title
WeeFIM
Description
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).
Time Frame
20 minute
Title
PBBS
Description
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).
Time Frame
15 minute
Title
Modified Ashworth Scale (MAS).
Description
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.
Time Frame
15 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tülay Çevik Saldıran, PhD
Organizational Affiliation
Bitlis Eren University
Official's Role
Study Chair
Facility Information:
Facility Name
Okan University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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