Hemiparetic Cerebral PalsyNCT05349136

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

A study testing Synchronous telerehabilitation group and Asynchronous telerehabilitation group in people with Hemiparetic Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Hemiparetic Cerebral Palsy
What is being tested?: Synchronous telerehabilitation group and Asynchronous telerehabilitation group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 9 Nov 2022to 17 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Synchronous and Asynchronous Telerehabilitation-Based Action Observation Treatment in 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).

Conditions: Hemiparetic Cerebral Palsy
Being tested: Synchronous telerehabilitation group, Asynchronous telerehabilitation group
Keywords: Cerebral Palsy, Hemiparesis, Telerehabilitation, Action Observation Treatment
Medical subject headings: Cerebral Palsy, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Synchronous telerehabilitation groupOther
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.
Asynchronous telerehabilitation groupOther
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.

Study groups in NCT05349136
Study group	Role	What they receive
Synchronous telerehabilitation group	Experimental	Synchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy Receives: Other: Synchronous telerehabilitation group
Asynchronous telerehabilitation group	Experimental	Asynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy Receives: Other: Asynchronous telerehabilitation group
Control group	No intervention	Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T2 (8 weeks after the end of the treatment/control period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202217 Sep 2024

First posted27 Apr 2022
Study start9 Nov 2022
Primary completion17 Sep 2024
Study completion17 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemiparetic Cerebral PalsyStudies of the same condition, open and under way.
More trials run by Marmara UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05349136
Sponsor's protocol ID: 09.2020.1353
Status last verified: Apr 2022
First submitted: 5 Apr 2022
Last updated: 19 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic

All Hemiparetic Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Synchronous and Asynchronous Telerehabilitation-Based Action Observation Treatment in Children with Hemiparetic Cerebral Palsy
ClinicalTrials.gov ID: NCT05349136
Acronym / sponsor ID: 09.2020.1353
Conditions: Hemiparetic Cerebral Palsy
Keywords: Cerebral Palsy, Hemiparesis, Telerehabilitation, Action Observation Treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 9 Nov 2022 (actual)
Primary completion: 17 Sep 2024 (actual)
Study completion: 17 Sep 2024 (actual)
First posted: 27 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Synchronous telerehabilitation group	Experimental	Other: Synchronous telerehabilitation groupSynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Asynchronous telerehabilitation group	Experimental	Other: Asynchronous telerehabilitation groupAsynchronous telerehabilitation based-Action Observation Treatment and conventional physiotherapy
Control group	No intervention	–Conventional physiotherapy

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Synchronous telerehabilitation groupThis 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.	Other	Synchronous telerehabilitation group
Asynchronous telerehabilitation groupThis 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.	Other	Asynchronous telerehabilitation group

Primary outcome

Changes in Assisting Hand Assessment
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)
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.

8 secondary outcomes

Changes in Box and Blocks Test
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)
Changes in Minnesota Manual Dexterity Test
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)
Changes in Children's Hand-use Experience 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)
Changes in ABILHAND-kids
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)
Changes in Participation and Environment Measure - Children and Youth
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)
Changes in Trunk Impairment 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)
Treatment Satisfaction Assessed by the Visual Analog Scale
Time frame: T1 (within 1 week after the end of the treatment/control period)
Treatment Satisfaction Assessed by the Visual Analog Scale
Time frame: T2 (8 weeks after the end of the treatment/control period)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Individual participant dataSharing planned: No

Related trials for Hemiparetic Cerebral Palsy

Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gonul Acar, PhD study director

Marmara University

Hilal B Can, MSc principal investigator

Marmara University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Synchronous telerehabilitation group and Asynchronous telerehabilitation group in people with Hemiparetic Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Assisting Hand Assessment (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.