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

NCT05349136 | Completed

• 1 other identifier: 09.2020.1353
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparetic Cerebral Palsy

Keywords

Cerebral Palsy; Hemiparesis; Telerehabilitation; Action Observation Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in Box and Blocks Test

  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

  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

  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

  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

  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)

Study Arms (3)

Synchronous telerehabilitation group

EXPERIMENTAL

Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy

Other: Synchronous telerehabilitation group

Asynchronous telerehabilitation group

EXPERIMENTAL

Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy

Other: Asynchronous telerehabilitation group

Control group

NO INTERVENTION

Conventional physiotherapy

Interventions

Synchronous telerehabilitation group OTHER

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.

Synchronous telerehabilitation group

Asynchronous telerehabilitation group OTHER

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.

Asynchronous telerehabilitation group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gonul Acar, PhD

  Marmara University

  STUDY DIRECTOR

• Hilal B Can, MSc

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 27, 2022
• Study Start: November 9, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: November 19, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)