Telerehabilitation-Based Action Observation Treatment in Children With Hemiparetic Cerebral Palsy
Primary Purpose
Hemiparetic Cerebral Palsy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synchronous telerehabilitation group
Asynchronous telerehabilitation group
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparetic Cerebral Palsy focused on measuring Cerebral Palsy, Hemiparesis, Telerehabilitation, Action Observation Treatment
Eligibility Criteria
Inclusion Criteria:
- Presence of confirmed hemiparetic cerebral palsy
- Manual Ability Classification System ≤ 3
- Age between 6 and 12
- Absence of major visual and/or auditory deficits
- Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
- House Functional Classification Score ≥4
- Grade ≤2 on the Modified Ashworth Scale
Exclusion Criteria:
- Seizures uncontrolled by therapy
- Surgery and/or botulinum toxin-A injections in the upper limb within 6 months prior to the baseline assessment
- Having a disabling behavioral disorder to treatment
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Synchronous telerehabilitation group
Asynchronous telerehabilitation group
Control group
Arm Description
Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Conventional physiotherapy
Outcomes
Primary Outcome Measures
Changes in Assisting Hand Assessment
The children's the assisting hand use in activities requiring bimanual use will be evaluated with the Assisting Hand Assessment. The game, which can be performed in a time frame of 10-15 minutes, will be recorded. Then the video will be watched. Twenty-two components regarding general use, arm use, grasp and release, fine motor adjustment, coordination, and pace of the performance will be scored on a four-point scale.
Secondary Outcome Measures
Changes in Box and Blocks Test
The children's unilateral gross manual dexterity will be evaluated with the Box and Blocks Test, which is a timed test. First, the dominant hand will be asked to place the blocks from one side of the box to the other in 1 minute. The number of blocks placed on the other side of the box is recorded. Then it will be repeated with the other hand. The test can be completed in less than 10 minutes.
Changes in Minnesota Manual Dexterity Test
The children's manual dexterity required to turn and/or place disks with one or both hands will be assessed with the Minnesota Manual Dexterity Test. The completion time of the tasks will be recorded.
Changes in Children's Hand-use Experience Questionnaire
The children's use of assisting hands in various bimanual activities will be assessed with the Children's Hand-use Experience Questionnaire. This questionnaire will be completed by their parents.
Changes in ABILHAND-kids
The children's ease or difficulty in performing bimanual activities will be assessed with the ABILHAND-kids, which is a parent questionnaire.
Changes in Participation and Environment Measure - Children and Youth
The children's participation in the home, at school, and in the community will be assessed with the Participation and Environment Measure-Children and Youth, which is a parent questionnaire.
Changes in Trunk Impairment Scale
The children's static sitting balance, dynamic sitting balance, and trunk coordination will be assessed with the Trunk Impairment Scale. The total score is between 0-23. A higher score indicates better performance.
Treatment Satisfaction Assessed by the Visual Analog Scale
The children and their parents' treatment satisfaction will be assessed separately with the visual analog scale. The value is between 0-10. A higher value indicates better satisfaction.
Treatment Satisfaction Assessed by the Visual Analog Scale
The children and their parents' treatment satisfaction will be assessed separately with the visual analog scale. The value is between 0-10. A higher value indicates better satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05349136
Brief Title
Telerehabilitation-Based Action Observation Treatment in Children With Hemiparetic Cerebral Palsy
Official Title
Effectiveness of Synchronous and Asynchronous Telerehabilitation-Based Action Observation Treatment in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara 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
The aim of this study is to evaluate the effectiveness of action observation therapy applied using two different telerehabilitation techniques (synchronous and asynchronous) to children with hemiparetic cerebral palsy.
Detailed Description
Action observation treatment (AOT) is a new rehabilitation technique. AOT involves the observation of purposeful actions, presented through a video-clip or performed by an operator, in order to imitate and then perform them. In this study, AOT will be applied by observing actions to be presented via video-clips. 36 children with hemiparetic cerebral palsy who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into three groups. The groups are: a) the synchronous telerehabilitation group, where AOT will be applied under the supervision of a physiotherapist via videoconferencing; b) the asynchronous telerehabilitation group, where AOT will be applied under parental supervision; and c) control group. Both the synchronous telerehabilitation group and the asynchronous telerehabilitation group will receive AOT 5 days a week for 3 weeks, for a total of 15 sessions, in addition to conventional physiotherapy. The control group will only receive conventional physiotherapy. A total of three evaluations will be made at baseline (T0), at the end of treatment (T1), and at two months of follow-up (T2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparetic Cerebral Palsy
Keywords
Cerebral Palsy, Hemiparesis, Telerehabilitation, Action Observation Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synchronous telerehabilitation group
Arm Type
Experimental
Arm Description
Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Arm Title
Asynchronous telerehabilitation group
Arm Type
Experimental
Arm Description
Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Synchronous telerehabilitation group
Intervention Description
This group will receive Action Observation Treatment with a synchronous telerehabilitation method. Children in this group will be applied Action Observation Treatment 5 days a week for 3 weeks, for a total of 15 sessions under the supervision of a physiotherapist via videoconferencing.
Intervention Type
Other
Intervention Name(s)
Asynchronous telerehabilitation group
Intervention Description
This group will receive Action Observation Treatment with an asynchronous telerehabilitation method. Children in this group will be applied Action Observation Treatment 5 days a week for 3 weeks, for a total of 15 sessions under parental supervision.
Primary Outcome Measure Information:
Title
Changes in Assisting Hand Assessment
Description
The children's the assisting hand use in activities requiring bimanual use will be evaluated with the Assisting Hand Assessment. The game, which can be performed in a time frame of 10-15 minutes, will be recorded. Then the video will be watched. Twenty-two components regarding general use, arm use, grasp and release, fine motor adjustment, coordination, and pace of the performance will be scored on a four-point scale.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Secondary Outcome Measure Information:
Title
Changes in Box and Blocks Test
Description
The children's unilateral gross manual dexterity will be evaluated with the Box and Blocks Test, which is a timed test. First, the dominant hand will be asked to place the blocks from one side of the box to the other in 1 minute. The number of blocks placed on the other side of the box is recorded. Then it will be repeated with the other hand. The test can be completed in less than 10 minutes.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Changes in Minnesota Manual Dexterity Test
Description
The children's manual dexterity required to turn and/or place disks with one or both hands will be assessed with the Minnesota Manual Dexterity Test. The completion time of the tasks will be recorded.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Changes in Children's Hand-use Experience Questionnaire
Description
The children's use of assisting hands in various bimanual activities will be assessed with the Children's Hand-use Experience Questionnaire. This questionnaire will be completed by their parents.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Changes in ABILHAND-kids
Description
The children's ease or difficulty in performing bimanual activities will be assessed with the ABILHAND-kids, which is a parent questionnaire.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Changes in Participation and Environment Measure - Children and Youth
Description
The children's participation in the home, at school, and in the community will be assessed with the Participation and Environment Measure-Children and Youth, which is a parent questionnaire.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Changes in Trunk Impairment Scale
Description
The children's static sitting balance, dynamic sitting balance, and trunk coordination will be assessed with the Trunk Impairment Scale. The total score is between 0-23. A higher score indicates better performance.
Time Frame
Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the treatment/control period); T2 (8 weeks after the end of the treatment/control period)
Title
Treatment Satisfaction Assessed by the Visual Analog Scale
Description
The children and their parents' treatment satisfaction will be assessed separately with the visual analog scale. The value is between 0-10. A higher value indicates better satisfaction.
Time Frame
T1 (within 1 week after the end of the treatment/control period)
Title
Treatment Satisfaction Assessed by the Visual Analog Scale
Description
The children and their parents' treatment satisfaction will be assessed separately with the visual analog scale. The value is between 0-10. A higher value indicates better satisfaction.
Time Frame
T2 (8 weeks after the end of the treatment/control period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of confirmed hemiparetic cerebral palsy
Manual Ability Classification System ≤ 3
Age between 6 and 12
Absence of major visual and/or auditory deficits
Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
House Functional Classification Score ≥4
Grade ≤2 on the Modified Ashworth Scale
Exclusion Criteria:
Seizures uncontrolled by therapy
Surgery and/or botulinum toxin-A injections in the upper limb within 6 months prior to the baseline assessment
Having a disabling behavioral disorder to treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonul Acar, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hilal B Can, MSc
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation-Based Action Observation Treatment in Children With Hemiparetic Cerebral Palsy
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