Hybrid Approach to Pediatric Rehabilitation

NCT06547762 | Enrolling By Invitation DMC

• 1 other identifier: 063-22
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Traumatic Brain Injury; Orthopedic Disorder

Keywords

Occupational Therapy; Physical Therapy; Speech and Language Pathology; Psychology; Telerehabilitation; Hybrid Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Improved Function

  2 months

Study Arms (1)

Hybrid rehabilitation

EXPERIMENTAL

Children will receive one day of remote rehabilitation. All other days children will receive therapy at hospital

Other: Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis

Interventions

Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis OTHER

Hybrid rehabilitation. Out patients will receive one day a week of remote therapy and the remaining (1-4 days) in person at rehabilitation hospital

Hybrid rehabilitation

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with physical disability
• Children receiving treatment via the out patient department
• Children who receive more than one day of treatment a week.
• Children who are able to follow instructions
• Families who can interact with a computer and other technologies

You may not qualify if:

• Children who are visually impaired
• Children who are hearing impaired
• Children who receive hydrotherapy every day of their rehabilitation program

Sponsors & Collaborators

• Alyn Pediatric & Adolescent Rehabilitation Hospital: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Alyn Pediatric and Adolescent Rehabilitation Center

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries, Traumatic; Musculoskeletal Diseases; Speech

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Verbal Behavior; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI, PARC ALYN; Deputy Director General

Model Details: Control group and Intervention group

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 9, 2024
• Study Start: August 16, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)