Cerebral Palsy (CP)NCT06800014
Effectiveness of Wearable Trackers and Telerehabilitation in Cerebral Palsy
A study testing Telerehabilitation and Conventional exercise in people with Cerebral Palsy (CP) and Telerehabilitation, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP), Telerehabilitation, Physical Activity
- What is being tested?
- Telerehabilitation and Conventional exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 7 Aug 2025
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 14 and 18 years old
- Diagnosed with cerebral palsy
- Currently enrolled in a regular rehabilitation programme
- Level 1-3 according to Gross Motor Function Classification System (GMFCS)
- No cognitive impairments affecting the understanding of exercise programmes
- Voluntary informed consent to participate
- No recent surgeries (e.g. botox, muscle relaxation) within the past 6 months
- No socioeconomic issues related to the use of smart devices
Who cannot join
- The impact of recent surgical procedures or medical interventions on physical performance.
- The influence of health conditions that affect the entire body and physical performance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Kütahya
About this study
Official title: Investigation of the Effectiveness of Wearable Activity Trackers and Mobile Application-Supported Telerehabilitation in Individuals With Cerebral Palsy
The inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. As a result, it is well known that daily life often hinders the implementation of prescribed home programmes, leading to neglect. In the rehabilitation of people with cerebral palsy, physiotherapists face difficulties in monitoring patients and ensuring compliance with home exercise programmes. Both people with cerebral palsy and their carers often experience dissatisfaction and lack of motivation regarding the monitoring and control of development and activity.
This study aims to evaluate the effectiveness of a telerehabilitation programme supported by a mobile application and a wearable activity tracker, in addition to a standard rehabilitation programme, on physical activity levels, quality of life, sleep quality, balance, activity participation and motivation, and patient satisfaction in people with cerebral palsy.
- Conditions
- Cerebral Palsy (CP), Telerehabilitation, Physical Activity
- Being tested
- Telerehabilitation, Conventional exercise
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Participants in the telerehabilitation group will receive weekly home exercise instructions through a mobile application installed on their or their caregivers' smartphones, in addition to their standard rehabilitation program. These instructions will include videos, reminders, and directives for the exercises, with compliance monitored through mini-surveys delivered via the app.
Conventional exerciseOther
Participants in the conventional exercise group will continue their standard rehabilitation program supplemented with printed home exercise instructions, including visuals and text, similar to the content provided to the TG.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Not described Receives: Other: Telerehabilitation |
| Control | Experimental | Not described Receives: Other: Conventional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Questionnaire for Adolescents
The PAQ-A was developed by Kowalski et al. in 1997 to assess physical activity levels in adolescents (Kowalski et al., 2004). It is suitable for the 14-20 age group. The questionnaire consists of nine questions and assesses physical activity levels over the past seven days. The Turkish validity and reliability study was conducted in 2017. PAQ-A contains eight questions scored between 1 and 5, with a ninth question asking about any condition that might have prevented physical activity during the past week. A score of "1" indicates low-intensity physical activity, while "5" indicates high-intensity physical activity. The ninth question is not included in the scoring. The total score is calculated by averaging the scores of all questions (Aygün Polat, 2017).
Measured: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Physical Activity Enjoyment Scale
The PAES is a satisfaction scale developed by Mullen et al., consisting of eight items rated on a 7-point Likert scale (Mullen, 2011). The Turkish validity and reliability study was conducted by Bozkurt et al. (Bozkurt et al., 2022).
Measured: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Secondary outcomes (3)
Cerebral Palsy Quality of Life Questionnaire for Teen
The CP-QoL Teen scale is a quality-of-life questionnaire designed for adolescents with cerebral palsy (Davis et al., 2013). Its Turkish adaptation was carried out by Çelik et al. (Çelik, 2012). The CP-QoL Teen scale has two versions: one for caregivers and one self-report version for adolescents. The adolescent self-report version consists of six categories: family and friends, school, participation, communication, health, special equipment, and pain and discomfort. These categories are evaluated under four sections: general well-being and participation, communication and physical health, school situation, and social well-being. The caregiver version includes two additional categories: service assessment and family health (Davis et al., 2013). Scoring involves two steps:
- Items are transformed to a scale with a possible range of 0-100;
- The algebraic mean of item values is computer for each domain.
Measured: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Pittsburgh Sleep Quality Index
The PSQI is a scale that provides information on sleep quality and the type and severity of sleep disorders in the past month (Buysse et al., 1989). Sleep quality is evaluated based on sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. The Turkish validity and reliability study of the scale was conducted by Ağargün et al. (Ağargün et al., 1996). Each question is scored between 0 and 3, with higher scores indicating poorer sleep quality. A total score of less than 5 indicates "Good sleep quality," while a score of 5 or above indicates "Poor sleep quality."
Measured: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Trunk Control Measurement Scale
The TCMS is a valid and reliable scale for assessing trunk control in individuals with cerebral palsy (Heyrman, 2011). The Turkish validity and reliability study was conducted by Özal et al. (Özal, 2019). The TCMS evaluates two main components of trunk control during functional activities: maintaining balance within the support surface and actively moving body parts. Therefore, the TCMS consists of two main sections: static sitting balance and dynamic sitting balance.
Measured: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Oct 2024
- Primary completion1 Jul 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800014
- Sponsor's protocol ID
- 2024/02-29
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Wearable Activity Trackers and Mobile Application-Supported Telerehabilitation in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06800014
- Acronym / sponsor ID
- 2024/02-29
- Conditions
- Cerebral Palsy (CP), Telerehabilitation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 29 Jan 2025 (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 inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. As a result, it is well known that daily life often hinders the implementation of prescribed home programmes, leading to neglect. In the rehabilitation of people with cerebral palsy, physiotherapists face difficulties in monitoring patients and ensuring compliance with home exercise programmes. Both people with cerebral palsy and their carers often experience dissatisfaction and lack of motivation regarding the monitoring and control of development and activity.
This study aims to evaluate the effectiveness of a telerehabilitation programme supported by a mobile application and a wearable activity tracker, in addition to a standard rehabilitation programme, on physical activity levels, quality of life, sleep quality, balance, activity participation and motivation, and patient satisfaction in people with cerebral palsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Telerehabilitation |
| Control | Experimental | Other: Conventional exercise |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Aged between 14 and 18 years old
- Diagnosed with cerebral palsy
- Currently enrolled in a regular rehabilitation programme
- Level 1-3 according to Gross Motor Function Classification System (GMFCS)
- No cognitive impairments affecting the understanding of exercise programmes
Key exclusion criteria (2 listed)
- The impact of recent surgical procedures or medical interventions on physical performance.
- The influence of health conditions that affect the entire body and physical performance.
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 |
|---|---|---|
| TelerehabilitationParticipants in the telerehabilitation group will receive weekly home exercise instructions through a mobile application installed on their or their caregivers' smartphones, in addition to their standard rehabilitation program. These instructions will include videos, reminders, and directives for the exercises, with compliance monitored through mini-surveys delivered via the app. | Other | Telerehabilitation |
| Conventional exerciseParticipants in the conventional exercise group will continue their standard rehabilitation program supplemented with printed home exercise instructions, including visuals and text, similar to the content provided to the TG. | Other | Control |
Primary outcome
Physical Activity Questionnaire for Adolescents
Time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
The PAQ-A was developed by Kowalski et al. in 1997 to assess physical activity levels in adolescents (Kowalski et al., 2004). It is suitable for the 14-20 age group. The questionnaire consists of nine questions and assesses physical activity levels over the past seven days. The Turkish validity and reliability study was conducted in 2017. PAQ-A contains eight questions scored between 1 and 5, with a ninth question asking about any condition that might have prevented physical activity during the past week. A score of "1" indicates low-intensity physical activity, while "5" indicates high-intensity physical activity. The ninth question is not included in the scoring. The total score is calculated by averaging the scores of all questions (Aygün Polat, 2017).
Physical Activity Enjoyment Scale
Time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
The PAES is a satisfaction scale developed by Mullen et al., consisting of eight items rated on a 7-point Likert scale (Mullen, 2011). The Turkish validity and reliability study was conducted by Bozkurt et al. (Bozkurt et al., 2022).
3 secondary outcomes
Cerebral Palsy Quality of Life Questionnaire for Teen
Time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Pittsburgh Sleep Quality Index
Time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
Trunk Control Measurement Scale
Time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.
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 27 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Conventional exercise in people with Cerebral Palsy (CP) and Telerehabilitation, run by Kutahya Health Sciences 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 8 inclusion and 2 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 27 Aug 2025. 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?
Physical Activity Questionnaire for Adolescents (time frame: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.). 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?
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 27 Aug 2025.