An interventional study of Individualized intervention in Children With Physical Disabilities and Adolescents With Physical Disabilities, sponsored by European University Miguel de Cervantes. Completed at 1 site in Spain. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by European University Miguel de Cervantes · Not applicable, Interventional, and Treatment
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.
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.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →European University Miguel de Cervantes is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
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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.
Behavioral: Individualized intervention
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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).
Time frame: 0 week, 8 weeks, 20 weeks
Functional variables: gas consumption analysis
Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).
Time frame: 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.
Time frame: 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.
Time frame: 0 week, 8 weeks, 20 weeks
Clinical variables: Bioelectrical Impedance Analysis
Changes in fat mass percentage.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 0 week, 8 weeks, 20 weeks
Muscle strength
Measured by manual digital dynamometry of the quadriceps muscle groups.
Time frame: 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.
Time frame: 0 week, 8 weeks, 20 weeks
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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European University Miguel de Cervantes