Children With Physical DisabilitiesTelehealthNCT06514287
Telehealth Interventions for Daily Routine Activities in Children and Adolescents With Disabilities
A study testing Individualized intervention in people with Children With Physical Disabilities and Adolescents With Physical Disabilities, run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Children With Physical Disabilities, Adolescents With Physical Disabilities
- What is being tested?
- Individualized intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2022to 25 Oct 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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants between five and 21 years old.
- Participants with a physical disability.
- Participants with the ability to walk with or without an assistive device.
Who cannot join
- Participants with orthopedic surgery within the past 6 months.
- Participants with a health condition limiting physical activity.
- Participants with contraindications to exercise.
- Participants unable to understand the instructions to complete the outcome measures.
Trial locations and contacts
1 site in 1 country.
Spain1 site
European University Miguel of Cervante
Valladolid, Castille and León, 47012
About this study
Official title: Telehealth Intervention for Performance of Activities in Daily Routines in Children and Adolescents With Disabilities
Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities. The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention.
Read the detailed description
Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The International Classification of Functioning, Disability, and Health defines activity as whole-body actions and participation as involvement in life situations. Telehealth is a method of service delivery that might enable service providers and families to collaborate on goals for performance of activities during daily routines. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities.
The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention. It is a pragmatic intervention where goals for physical activities in daily routines took into consideration the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. There are two follow-ups: first after twelve weeks y the last two years later.
- Being tested
- Individualized intervention
- Keywords
- children, adolescents, disability, physical therapy, participation, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized interventionBehavioural
It is a pragmatic intervention where three priorities were identified for physical activities in daily routines, considering the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. The intervention plan was implemented via online consultation using WhatsApp text, audio, and video messaging for asynchronous and synchronous communication. The focus of intervention was incorporating practice of goals into daily activity routines.
| Study group | Role | What they receive |
|---|---|---|
| Individualized intervention | Other | It is a pragmatic intervention where three priorities were identified for physical activities in daily routines, considering the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. The intervention plan was implemented via online consultation using WhatsApp text, audio, and video messaging for asynchronous and synchronous communication. The focus of intervention was incorporating practice of goals into daily activity routines. Receives: Behavioral: Individualized intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized outcome measure of a client's perception of their occupational performance. Occupational performance refers to an individual's experiences in performing activities in daily life. The parent or child identify their priorities for activities in daily living. After priorities are identified, each is rated for current performance and satisfaction with current performance on a scale of 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied). An increase of two or more points for is considered a clinically significant change.
Measured: 0 week, 8 weeks, 20 weeks
Goal Attainment Scaling (GAS)
GAS is a standardized individualized outcome measure in which five measurable outcomes are specified for each goal. A score of -2 indicates the level of function at the start of intervention, 0 is the expected level of function, and +2 indicates a level of function that far exceeds the expected level of function following the intervention. The composite change score is expressed as a standardized T-score (mean = 50, standard deviation = 10). A T-score of 50 corresponds to achievement at the expected level.
Measured: 0 week, 8 weeks, 20 weeks
Activity log
Participants were provided a sheet that listed the activities for each goal listed and asked to record the days and times activities were practiced.
Measured: 8 weeks
Interviews to families
At post-intervention, short follow-up and long follow-up, participants were asked about the practice or their individualized goals, if the intervention was useful for them, and if the intervention empower them to plan new personal goals in the future and ask for help, when needed. The responses will be recorded.
Measured: 8 weeks, 20 weeks, 124 weeks
Functional variables: physical activity levels with accelerometery
It is one of the most reliable techniques for recording and storing the amount and level of physical activity performed by each person in a given period of time, considering mainly light physical activity (LPA) and moderate to-vigorous activity (MVPA). The levels of physical activity of the participants will be recorded over a seven-day period using the GT3X+ accelerometer. The output from the ActiGraph will be provided in 'counts'.
Measured: 0 week, 8 weeks, 20 weeks
Functional variables: physical activity levels with questionnaires
Physical activity levels are recorded using an PAQ-C PAQ-A Physical Activity Questionnaire for children and adolescents (PAQ-C and PAQ-A). They are self-administered questionnaires to measure physical activity levels in children aged approximately 8-14 years (PAQ-C) and adolescents aged approximately 14-20 years (PAQ-A).
Measured: 0 week, 8 weeks, 20 weeks
Functional variables: gas consumption analysis
Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).
Measured: 0 week, 8 weeks, 20 weeks
Functional variables: Heart rate
Changes in heart rate, measured by a polar H10 Heart Rate Monitor with Chest Strap.
Measured: 0 week, 8 weeks, 20 weeks
Clinical variables: Body composition
Changes in measurements by Body Mass Index (BMI), where weight and height will be combined to report it in kg/m^2.
Measured: 0 week, 8 weeks, 20 weeks
Clinical variables: Bioelectrical Impedance Analysis
Changes in fat mass percentage.
Measured: 0 week, 8 weeks, 20 weeks
Children's Assessment of Participation and Enjoyment (CAPE)
It is a tool designed to record how the child, with or without a disability, participates in 55 daily activities outside of school activities. It addresses the diversity (0- no practised, 1- practised) and intensity of the child's activity participation (scoring 1-7, where 1 is less to 7 more practice), with whom and where the activities are typically done (scoring form 1-5, 1 alone to 5 with others), and the child's enjoyment of the activities (scoring 1-5, 1- no enjoyment at all to 7- I love it).
Measured: 0 week, 8 weeks, 20 weeks
Participation and Environment Measure for Children and Youth (PEM-CY)
It is a parent-reported tool that examines participation and environmental factors affecting child participation in three contexts: home, school, and community. Summary scores are calculated for frequency (average, 0-never to 7-daily), involvement (average, 1-minimally involved to 5-very involved), and perceived environmental support (percentage).
Measured: 0 week, 8 weeks, 20 weeks
Muscle thickness of the vastus lateralis quadriceps with ultrasound
The thickness of the muscle (mm) will be recorded by performing longitudinal and transverse ultrasound images.
Measured: 0 week, 8 weeks, 20 weeks
Pennation angle of the vastus lateralis quadriceps with ultrasound
The pennation angle (degree) of the muscle will be recorded by performing longitudinal and transverse ultrasound images.
Measured: 0 week, 8 weeks, 20 weeks
Muscle strength
Measured by manual digital dynamometry of the quadriceps muscle groups.
Measured: 0 week, 8 weeks, 20 weeks
Muscle strength measured by Five times sit to stand test (FTSTS)
This is a test to evaluate the functional strength of the lower extremities.
Measured: 0 week, 8 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start31 Jan 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Children With Physical DisabilitiesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Santos Lozano, PhD, Principal investigator, Universidad Europea Miguel de Cervantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514287
- Sponsor's protocol ID
- PI-DOC006-Telehealth
- Acronym
- Telehealth
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palisano RJ, Chiarello LA, King GA, Novak I, Stoner T, Fiss A. Participation-based therapy for children with physical disabilities. Disabil Rehabil. 2012;34(12):1041-52. doi: 10.3109/09638288.2011.628740. Epub 2011 Nov 14.
PubMed 22080765Organization, W. H., IFC: International Classification of Functioning, Disability and Health. 2001.
Matey-Rodriguez C, Pico M, Robles-Garcia V, Musso-Daury L, Santos-Lozano A, Palisano RJ. Collaborative Telehealth Intervention for Performance of Activities During Daily Routines by Children and Adolescents with Physical Disabilities: A Feasibility Study. Phys Occup Ther Pediatr. 2026;46(4):675-693. doi: 10.1080/01942638.2026.2618039. Epub 2026 Jan 19.
PubMed 41555535
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention for Performance of Activities in Daily Routines in Children and Adolescents With Disabilities
- ClinicalTrials.gov ID
- NCT06514287
- Acronym / sponsor ID
- Telehealth / PI-DOC006-Telehealth
- Keywords
- children, adolescents, disability, physical therapy, participation, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 23 Jul 2024 (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.
Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities. The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention.
Detailed description
Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The International Classification of Functioning, Disability, and Health defines activity as whole-body actions and participation as involvement in life situations. Telehealth is a method of service delivery that might enable service providers and families to collaborate on goals for performance of activities during daily routines. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities.
The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention. It is a pragmatic intervention where goals for physical activities in daily routines took into consideration the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. There are two follow-ups: first after twelve weeks y the last two years later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized intervention | Other | Behavioral: Individualized interventionIt is a pragmatic intervention where three priorities were identified for physical activities in daily routines, considering the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. The intervention plan was implemented via online consultation using WhatsApp text, audio, and video messaging for asynchronous and synchronous communication. The focus of intervention was incorporating practice of goals into daily activity routines. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants between five and 21 years old.
- Participants with a physical disability.
- Participants with the ability to walk with or without an assistive device.
Key exclusion criteria (4 listed)
- Participants with orthopedic surgery within the past 6 months.
- Participants with a health condition limiting physical activity.
- Participants with contraindications to exercise.
- Participants unable to understand the instructions to complete the outcome measures.
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 |
|---|---|---|
| Individualized interventionIt is a pragmatic intervention where three priorities were identified for physical activities in daily routines, considering the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. The intervention plan was implemented via online consultation using WhatsApp text, audio, and video messaging for asynchronous and synchronous communication. The focus of intervention was incorporating practice of goals into daily activity routines. | Behavioural | Individualized intervention |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 0 week, 8 weeks, 20 weeks
The COPM is an individualized outcome measure of a client's perception of their occupational performance. Occupational performance refers to an individual's experiences in performing activities in daily life. The parent or child identify their priorities for activities in daily living. After priorities are identified, each is rated for current performance and satisfaction with current performance on a scale of 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied). An increase of two or more points for is considered a clinically significant change.
Goal Attainment Scaling (GAS)
Time frame: 0 week, 8 weeks, 20 weeks
GAS is a standardized individualized outcome measure in which five measurable outcomes are specified for each goal. A score of -2 indicates the level of function at the start of intervention, 0 is the expected level of function, and +2 indicates a level of function that far exceeds the expected level of function following the intervention. The composite change score is expressed as a standardized T-score (mean = 50, standard deviation = 10). A T-score of 50 corresponds to achievement at the expected level.
Activity log
Time frame: 8 weeks
Participants were provided a sheet that listed the activities for each goal listed and asked to record the days and times activities were practiced.
Interviews to families
Time frame: 8 weeks, 20 weeks, 124 weeks
At post-intervention, short follow-up and long follow-up, participants were asked about the practice or their individualized goals, if the intervention was useful for them, and if the intervention empower them to plan new personal goals in the future and ask for help, when needed. The responses will be recorded.
Functional variables: physical activity levels with accelerometery
Time frame: 0 week, 8 weeks, 20 weeks
It is one of the most reliable techniques for recording and storing the amount and level of physical activity performed by each person in a given period of time, considering mainly light physical activity (LPA) and moderate to-vigorous activity (MVPA). The levels of physical activity of the participants will be recorded over a seven-day period using the GT3X+ accelerometer. The output from the ActiGraph will be provided in 'counts'.
Functional variables: physical activity levels with questionnaires
Time frame: 0 week, 8 weeks, 20 weeks
Physical activity levels are recorded using an PAQ-C PAQ-A Physical Activity Questionnaire for children and adolescents (PAQ-C and PAQ-A). They are self-administered questionnaires to measure physical activity levels in children aged approximately 8-14 years (PAQ-C) and adolescents aged approximately 14-20 years (PAQ-A).
Functional variables: gas consumption analysis
Time frame: 0 week, 8 weeks, 20 weeks
Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).
Functional variables: Heart rate
Time frame: 0 week, 8 weeks, 20 weeks
Changes in heart rate, measured by a polar H10 Heart Rate Monitor with Chest Strap.
Clinical variables: Body composition
Time frame: 0 week, 8 weeks, 20 weeks
Changes in measurements by Body Mass Index (BMI), where weight and height will be combined to report it in kg/m^2.
Clinical variables: Bioelectrical Impedance Analysis
Time frame: 0 week, 8 weeks, 20 weeks
Changes in fat mass percentage.
Children's Assessment of Participation and Enjoyment (CAPE)
Time frame: 0 week, 8 weeks, 20 weeks
It is a tool designed to record how the child, with or without a disability, participates in 55 daily activities outside of school activities. It addresses the diversity (0- no practised, 1- practised) and intensity of the child's activity participation (scoring 1-7, where 1 is less to 7 more practice), with whom and where the activities are typically done (scoring form 1-5, 1 alone to 5 with others), and the child's enjoyment of the activities (scoring 1-5, 1- no enjoyment at all to 7- I love it).
Participation and Environment Measure for Children and Youth (PEM-CY)
Time frame: 0 week, 8 weeks, 20 weeks
It is a parent-reported tool that examines participation and environmental factors affecting child participation in three contexts: home, school, and community. Summary scores are calculated for frequency (average, 0-never to 7-daily), involvement (average, 1-minimally involved to 5-very involved), and perceived environmental support (percentage).
Muscle thickness of the vastus lateralis quadriceps with ultrasound
Time frame: 0 week, 8 weeks, 20 weeks
The thickness of the muscle (mm) will be recorded by performing longitudinal and transverse ultrasound images.
Pennation angle of the vastus lateralis quadriceps with ultrasound
Time frame: 0 week, 8 weeks, 20 weeks
The pennation angle (degree) of the muscle will be recorded by performing longitudinal and transverse ultrasound images.
Muscle strength
Time frame: 0 week, 8 weeks, 20 weeks
Measured by manual digital dynamometry of the quadriceps muscle groups.
Muscle strength measured by Five times sit to stand test (FTSTS)
Time frame: 0 week, 8 weeks, 20 weeks
This is a test to evaluate the functional strength of the lower extremities.
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 9 Mar 2026.
- Background: PubMed 22080765Palisano RJ, Chiarello LA, King GA, Novak I, Stoner T, Fiss A. Participation-based therapy for children with physical disabilities. Disabil Rehabil. 2012;34(12):1041-52. doi: 10.3109/09638288.2011.628740. Epub 2011 Nov 14.
- BackgroundOrganization, W. H., IFC: International Classification of Functioning, Disability and Health. 2001.
- Results publication: PubMed 41555535Matey-Rodriguez C, Pico M, Robles-Garcia V, Musso-Daury L, Santos-Lozano A, Palisano RJ. Collaborative Telehealth Intervention for Performance of Activities During Daily Routines by Children and Adolescents with Physical Disabilities: A Feasibility Study. Phys Occup Ther Pediatr. 2026;46(4):675-693. doi: 10.1080/01942638.2026.2618039. Epub 2026 Jan 19.
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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.
Alejandro Santos Lozano, PhD principal investigator
Universidad Europea Miguel de Cervantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized intervention in people with Children With Physical Disabilities and Adolescents With Physical Disabilities, run by European University Miguel de Cervantes at 1 site in Spain.
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 3 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 9 Mar 2026. 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 Spain. 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?
Canadian Occupational Performance Measure (COPM) (time frame: 0 week, 8 weeks, 20 weeks). The study lists 16 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 NCT06514287, which also lists 3 linked publications.
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 9 Mar 2026.