Clinical trial NCT05349136: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparetic Cerebral Palsy
Keywords: Cerebral Palsy
Hemiparesis
Telerehabilitation
Action Observation Treatment
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Changes in Assisting Hand Assessment
timeFrame: 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 outcomes:
measure: Changes in Box and Blocks Test
timeFrame: 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)
measure: Changes in Minnesota Manual Dexterity Test
timeFrame: 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)
measure: Changes in Children's Hand-use Experience Questionnaire
timeFrame: 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)
measure: Changes in ABILHAND-kids
timeFrame: 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)
measure: Changes in Participation and Environment Measure - Children and Youth
timeFrame: 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)
measure: Changes in Trunk Impairment Scale
timeFrame: 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)
measure: Treatment Satisfaction Assessed by the Visual Analog Scale
timeFrame: T1 (within 1 week after the end of the treatment/control period)
measure: Treatment Satisfaction Assessed by the Visual Analog Scale
timeFrame: T2 (8 weeks after the end of the treatment/control period)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Gonul Acar, PhD
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Hilal B Can, MSc
role: PRINCIPAL_INVESTIGATOR
References: