Hybrid Approach to Pediatric Rehabilitation
NCT Number: NCT06547762
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy|Traumatic Brain Injury|Orthopedic Disorder
Interventions: OTHER: Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis
Sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Collaborators: Sheba Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-16
Completion Date: 2025-12-01
Locations: Alyn Pediatric and Adolescent Rehabilitation Center, Jerusalem, 91090, Israel

Summary:
Children and youth recovering from acquired injuries typically receive therapy via in-patient or outpatient rehabilitation (OPR). Families from peripheral areas often face significant time and financial burdens to access treatment. Over the past decade, evidence supporting the effectiveness of remote (online) rehabilitation has increased.

Objectives: 1. Identify facilitators and barriers to hybrid service adoption. 2. Develop a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy. 3. Compare hybrid rehabilitation to in-person rehabilitation at two centers in Israel in terms of: Adherence to therapy, Therapeutic alliance, Perceived quality of care (families and therapists), Functional effectiveness (measured by pre-post change in the Pediatric Evaluation of Disability Inventory, PEDI), Cost-effectiveness (including training requirements, physical space requirements, and costs); 4. Provide best practice recommendations for hybrid rehabilitation in children.

Research Methods: Focus Groups: Experts will develop a two-month hybrid program for approximately 200 children in OPR, commencing one month after in-person rehabilitation.

Evaluation Metrics: Therapy adherence, therapeutic alliance, and perceived quality of care will be assessed monthly and compared to in-person treatment. Insights will inform best practice guidelines for hybrid telerehabilitation.

Data Collection: Thematic Analysis: Analyzing focus group information. Comparative Metrics: Comparing measures of adherence, therapeutic alliance, and perceived quality of care between hybrid and in-person programs.

Difference-in-Difference Approach: Assessing functional differences between in-person and remote therapy.

Cost Analysis: Estimating direct and indirect costs per child for in-person versus remote rehabilitation.

Primary Outcome Measures: Adherence to therapy, Each child is prescribed a rehabilitation program. This outcome will follow the number of times that the child participated in the sessions- comparing to the prescribed program. For example if the child was supposed to participate in 5 weekly sessions and only participated in 3 sessions. The ratio of number of treatments performed to the number prescribed=adherence. A higher value indicates ahigher adherence level., 2 months|Therapeutic alliance, We will use the Working Alliance Inventory (WAI) (Horvath \& Greenberg, 1989), a self-report questionnaire designed to assess the structure of the therapeutic alliance. The items are rated on a 7-point scale (never to always). A higher scores reflect a higher quality of therapeutic alliance., 2 months|Perceived quality of care- therapists, The Clinician Evaluation of Tele rehabilitation Service (CETS) (Krasovsky et al., 2021) questionnaire for evaluating clinicians' feedback on tele rehabilitation will be completed. The scale is 1-5, with the higher score being better., 2 months|Perceived quality of care- families, For families the System Usability Scale (SUS) will be used, it is a10 item 5-point Likert scale to assess the user experience and perception of quality of care of the hybrid and in-person programs (Brooke, 1996). A higher score is better, 2 months|Cost-effectiveness of hybrid therapy, We will assess direct costs of in-person services, including direct payment schedules per week, for each treatment modality. Additionally, we will ask parents to complete information on travel (time and costs) and related expenses. The costs will be reported in monetary units, 2 months
Secondary Outcome Measures: Improved Function, The child's function will be assessed by the using the Pediatric Evaluation of Disability Inventory (PEDI). The Hebrew PEDI will be used (Elad et al., 2012).

The PEDI is a valid and reliable measure of basic activities of daily living. The scores are on a scale of 0-3, with a higher score indicating higher function., 2 months