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临床试验/NCT06514287
NCT06514287已完成不适用

Telehealth Intervention for Performance of Activities in Daily Routines in Children and Adolescents With Disabilities

European University Miguel de Cervantes1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Individualized intervention (Behavioral)

结局指标

主要结局

Muscle strength

时间窗: 0 week, 8 weeks, 20 weeks

Measured by manual digital dynamometry of the quadriceps muscle groups.

Functional variables: gas consumption analysis

时间窗: 0 week, 8 weeks, 20 weeks

Changes in oxygen consumption (VO2) and carbon dioxide production (CO2).

Goal Attainment Scaling (GAS)

时间窗: 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.

Interviews to families

时间窗: 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

时间窗: 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: Heart rate

时间窗: 0 week, 8 weeks, 20 weeks

Changes in heart rate, measured by a polar H10 Heart Rate Monitor with Chest Strap.

Clinical variables: Bioelectrical Impedance Analysis

时间窗: 0 week, 8 weeks, 20 weeks

Changes in fat mass percentage.

Children's Assessment of Participation and Enjoyment (CAPE)

时间窗: 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).

Activity log

时间窗: 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.

Clinical variables: Body composition

时间窗: 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.

Muscle thickness of the vastus lateralis quadriceps with ultrasound

时间窗: 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

时间窗: 0 week, 8 weeks, 20 weeks

The pennation angle (degree) of the muscle will be recorded by performing longitudinal and transverse ultrasound images.

Canadian Occupational Performance Measure (COPM)

时间窗: 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.

Functional variables: physical activity levels with questionnaires

时间窗: 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).

Participation and Environment Measure for Children and Youth (PEM-CY)

时间窗: 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 strength measured by Five times sit to stand test (FTSTS)

时间窗: 0 week, 8 weeks, 20 weeks

This is a test to evaluate the functional strength of the lower extremities.

次要结局

未报告次要终点

研究者

发起方
European University Miguel de Cervantes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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