Cerebral PalsyNCT05522452
Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP
A study testing Telerehabilitation and Face to face rehabilitation in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of synchronous telerehabilitation on improving upper extremity function in children with hemiparetic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Telerehabilitation and Face to face rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2022to 10 Apr 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of confirmed hemiparetic cerebral palsy
- Manual Ability Classification System ≤ 3
- Age between 6 and 18
- Absence of major visual and/or auditory deficits
- Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
- Family members being active mobile phone or computer and internet users
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
- Family's discontinuation of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Synchronous Telerehabilitation and Face to Face Method for Improving Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
The aim of this study is to investigate the effectiveness of synchronous telerehabilitation on improving upper extremity function in children with hemiparetic cerebral palsy.
Read the detailed description
46 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 two groups. The groups are: a) the synchronous telerehabilitation group; b) face to face rehabilitation group. Both groups will receive physiotherapy 2 days a week (1 session of 45 minutes) for 12 weels, for a total of 24 sessions. Evaluations will be made at baseline and the end of the treatment.
- Conditions
- Cerebral Palsy
- Being tested
- Telerehabilitation, Face to face rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Telerehabilitation program: Intervention will be applied by video interview for 12 weeks, 2 days a week, 45 minutes a day through the Zoom application. The application is free and can be installed on desktop or laptop computers, tablets and smartphones. The content of the activities to be done for that session by phone call to the parent before the interventions; Information will be given about the preparations such as keeping the materials on the table, suitable environment for that week's session and camera angle. Instructions and tips for parent support during the intervention will be given before and during the session. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.
Face to face rehabilitationOther
Face to face program: Intervention will be applied by physiotherapist for 12 weeks, 2 days a week, 45 minutes a day in clinic. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | The telerehabilitation group will participate in the treatment in their homes. While the participants are performing the activities in their own homes, applications will be made via webcam-based software (Zoom) and synchronous access via video and audio from the physiotherapist's computer screen. The activities determined by the physiotherapist will be directed to the family, and the activities will be adapted and implemented according to the child's needs and functional level.
Physiotherapy program will include the following applications:
* Tone regulation
* Active stretching and strengthening exercises
* Gross and fine motor activities to improve bilateral hand use
* Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning.
* Arts and crafts activities Receives: Other: Telerehabilitation |
| Face to face group | Active comparator | The face-to-face group will be treated in the clinic. To this group; The activities determined by the physiotherapist will be applied face to face.
Physiotherapy program will include the following applications:
* Tone regulation
* Active stretching and strengthening exercises
* Gross and fine motor activities to improve bilateral hand use
* Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning.
* Arts and crafts activities Receives: Other: Face to face rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Upper Extremity Skills Test (QUEST)
It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50
Measured: 12 weeks
The Selective Control of the Upper Extremity Scale (SCUES)
This test was developed to evaluate the selective motor control of the upper extremity. It is a very practical and useful video-based assessment tool that can be applied in less than 15 minutes. No special equipment is required other than a video camera. It offers the opportunity to evaluate the selective movements of the shoulder, elbow, forearm, wrist and fingers for both right and left extremities. The person administering the test passively shows the participant the movements they are asked to do. Then the participant is asked to actively perform the movement shown. While performing the participant movements; Head, trunk and other extremity movements are taken with a video camera to provide the opportunity to observe. The degree of selective motor control is determined as 0-3 points for each joint, depending on the person's ability to perform movements and their shape.
Measured: 12 weeks
Secondary outcomes (4)
ABILHAND-KIDS
t evaluates hand skills in children with CP according to the activity frames of ICF-CY. It consists of 21 items. The highest score is 20, the lowest score is 0.
Measured: 12 weeks
Shriners Hospital Upper Extremity Evaluation (SHUEE)
SHUEE is an assessment developed to measure upper extremity function in children with hemiplegic cerebral palsy. SHUEE is a video-based assessment administered by an occupational therapist using standardized objects and tasks. The evaluation takes about 15 minutes.
Measured: 12 weeks
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)
This instrument is useful for evaluating interventions designed to improve the lives of children.
Measured: 12 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
Pediatric Evaluation of Disability Inventory assesses key functional capabilities and performance in children ages 6 months to 7 years. PEDI is also useful for older children whose functional abilities are lower than those of seven-year-olds without disabilities.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start19 Oct 2022
- Primary completion7 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Polen Altun, Istanbul University - Cerrahpasa
- Investigators
- AYSE ZENGIN ALPOZGEN, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522452
- Sponsor's protocol ID
- PhD thesis
- Status last verified
- Jun 2023
- First submitted
- 29 Aug 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camden C, Pratte G, Fallon F, Couture M, Berbari J, Tousignant M. Diversity of practices in telerehabilitation for children with disabilities and effective intervention characteristics: results from a systematic review. Disabil Rehabil. 2020 Dec;42(24):3424-3436. doi: 10.1080/09638288.2019.1595750. Epub 2019 Apr 12.
PubMed 30978110
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Synchronous Telerehabilitation and Face to Face Method for Improving Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05522452
- Acronym / sponsor ID
- PhD thesis
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 31 Aug 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.
The aim of this study is to investigate the effectiveness of synchronous telerehabilitation on improving upper extremity function in children with hemiparetic cerebral palsy.
Detailed description
46 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 two groups. The groups are: a) the synchronous telerehabilitation group; b) face to face rehabilitation group. Both groups will receive physiotherapy 2 days a week (1 session of 45 minutes) for 12 weels, for a total of 24 sessions. Evaluations will be made at baseline and the end of the treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: TelerehabilitationThe telerehabilitation group will participate in the treatment in their homes. While the participants are performing the activities in their own homes, applications will be made via webcam-based software (Zoom) and synchronous access via video and audio from the physiotherapist's computer screen. The activities determined by the physiotherapist will be directed to the family, and the activities will be adapted and implemented according to the child's needs and functional level. Physiotherapy program will include the following applications: * Tone regulation * Active stretching and strengthening exercises * Gross and fine motor activities to improve bilateral hand use * Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning. * Arts and crafts activities |
| Face to face group | Active comparator | Other: Face to face rehabilitationThe face-to-face group will be treated in the clinic. To this group; The activities determined by the physiotherapist will be applied face to face. Physiotherapy program will include the following applications: * Tone regulation * Active stretching and strengthening exercises * Gross and fine motor activities to improve bilateral hand use * Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning. * Arts and crafts activities |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Presence of confirmed hemiparetic cerebral palsy
- Manual Ability Classification System ≤ 3
- Age between 6 and 18
- Absence of major visual and/or auditory deficits
- Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
Key exclusion criteria (4 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
- Family's discontinuation of 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 |
|---|---|---|
| TelerehabilitationTelerehabilitation program: Intervention will be applied by video interview for 12 weeks, 2 days a week, 45 minutes a day through the Zoom application. The application is free and can be installed on desktop or laptop computers, tablets and smartphones. The content of the activities to be done for that session by phone call to the parent before the interventions; Information will be given about the preparations such as keeping the materials on the table, suitable environment for that week's session and camera angle. Instructions and tips for parent support during the intervention will be given before and during the session. Intervention will be focused on upper extremity skills and activities of daily life of the individuals. | Other | Telerehabilitation group |
| Face to face rehabilitationFace to face program: Intervention will be applied by physiotherapist for 12 weeks, 2 days a week, 45 minutes a day in clinic. Intervention will be focused on upper extremity skills and activities of daily life of the individuals. | Other | Face to face group |
Primary outcome
Quality of Upper Extremity Skills Test (QUEST)
Time frame: 12 weeks
It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50
The Selective Control of the Upper Extremity Scale (SCUES)
Time frame: 12 weeks
This test was developed to evaluate the selective motor control of the upper extremity. It is a very practical and useful video-based assessment tool that can be applied in less than 15 minutes. No special equipment is required other than a video camera. It offers the opportunity to evaluate the selective movements of the shoulder, elbow, forearm, wrist and fingers for both right and left extremities. The person administering the test passively shows the participant the movements they are asked to do. Then the participant is asked to actively perform the movement shown. While performing the participant movements; Head, trunk and other extremity movements are taken with a video camera to provide the opportunity to observe. The degree of selective motor control is determined as 0-3 points for each joint, depending on the person's ability to perform movements and their shape.
4 secondary outcomes
ABILHAND-KIDS
Time frame: 12 weeks
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Time frame: 12 weeks
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)
Time frame: 12 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 12 weeks
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 15 Jun 2023.
- Background: PubMed 30978110Camden C, Pratte G, Fallon F, Couture M, Berbari J, Tousignant M. Diversity of practices in telerehabilitation for children with disabilities and effective intervention characteristics: results from a systematic review. Disabil Rehabil. 2020 Dec;42(24):3424-3436. doi: 10.1080/09638288.2019.1595750. Epub 2019 Apr 12.
- Individual participant dataSharing planned: No
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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.
AYSE ZENGIN ALPOZGEN, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Face to face rehabilitation in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa 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 6 inclusion and 4 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 15 Jun 2023. 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?
Quality of Upper Extremity Skills Test (QUEST) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05522452, which also lists 1 linked publication.
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 15 Jun 2023.