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CompletedNCT05349136Updated Nov 19, 2024

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

An interventional study of Synchronous telerehabilitation group and Asynchronous telerehabilitation group in Hemiparetic Cerebral Palsy, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hemiparetic Cerebral Palsy

Keywords

  • Cerebral Palsy
  • Hemiparesis
  • Telerehabilitation
  • Action Observation Treatment
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 36 is above the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Synchronous telerehabilitation group

    Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy

    Other: Synchronous telerehabilitation group

  • Experimental
    Asynchronous telerehabilitation group

    Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy

    Other: Asynchronous telerehabilitation group

  • No intervention
    Control group

    Conventional physiotherapy

Interventions

  • OtherSynchronous 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.

  • OtherAsynchronous 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.

06

What researchers measure

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.

    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 outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. 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.

    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)

  6. 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.

    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)

  7. 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.

    Time frame: T1 (within 1 week after the end of the treatment/control period)

  8. 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.

    Time frame: T2 (8 weeks after the end of the treatment/control period)

07

Study locations

1 site
  • Marmara University
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05349136
Lead sponsor
Marmara University
Responsible party
Hilal Başak Can (Research Assistant, Marmara University) — Principal investigator
First posted
Apr 27, 2022
Start date
Nov 9, 2022
Primary completion
Sep 17, 2024
Completion
Sep 17, 2024
Last update
Nov 19, 2024

Study contacts

Gonul Acar, PhD
study director · Marmara University
Hilal B Can, MSc
principal investigator · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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