Telerehabilitation-Based Action Observation Treatment in Children with Hemiparetic Cerebral Palsy

Effectiveness of Synchronous and Asynchronous Telerehabilitation-Based Action Observation Treatment in Children with Hemiparetic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Hemiparetic Cerebral Palsy
• Intervention / Treatment: Other: Synchronous telerehabilitation group; Other: Asynchronous telerehabilitation group

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synchronous telerehabilitation group; Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy	Other: Synchronous telerehabilitation group; 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.
Experimental: Asynchronous telerehabilitation group; Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy	Other: Asynchronous telerehabilitation group; 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.
No Intervention: Control group; Conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	T1 (within 1 week after the end of the treatment/control period)
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.	T2 (8 weeks after the end of the treatment/control period)

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Gonul Acar, PhD, Marmara University; Principal Investigator: Hilal B Can, MSc, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): September 17, 2024
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Telerehabilitation; Hemiparesis; Action Observation Treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 09.2020.1353

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
• product manufactured in and exported from the U.S.: No