Clinical trial NCT06514287: Telehealth Interventions for Daily Routine Activities in Children and Adolescents With Disabilities
Official title: Telehealth Intervention for Performance of Activities in Daily Routines in Children and Adolescents With Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Children With Physical Disabilities
Adolescents With Physical Disabilities
Keywords: children
adolescents
disability
physical therapy
participation
physical activity
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Participants between five and 21 years old.
* Participants with a physical disability.
* Participants with the ability to walk with or without an assistive device.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Goal Attainment Scaling (GAS)
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Activity log
timeFrame: 8 weeks
measure: Interviews to families
timeFrame: 8 weeks, 20 weeks, 124 weeks
measure: Functional variables: physical activity levels with accelerometery
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Functional variables: physical activity levels with questionnaires
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Functional variables: gas consumption analysis
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Functional variables: Heart rate
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Clinical variables: Body composition
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Clinical variables: Bioelectrical Impedance Analysis
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Children's Assessment of Participation and Enjoyment (CAPE)
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Participation and Environment Measure for Children and Youth (PEM-CY)
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Muscle thickness of the vastus lateralis quadriceps with ultrasound
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Pennation angle of the vastus lateralis quadriceps with ultrasound
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Muscle strength
timeFrame: 0 week, 8 weeks, 20 weeks
measure: Muscle strength measured by Five times sit to stand test (FTSTS)
timeFrame: 0 week, 8 weeks, 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: European University Miguel of Cervante
state: Castilla Y León
Study officials:
affiliation: Universidad Europea Miguel de Cervantes
name: Alejandro Santos Lozano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Organization, W. H., IFC: International Classification of Functioning, Disability and Health. 2001.