Cerebral PalsyNCT06547762
Hybrid Approach to Pediatric Rehabilitation
A study testing Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis in people with Cerebral Palsy and Traumatic Brain Injury, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Cerebral Palsy, Traumatic Brain Injury, Orthopedic Disorder
- What is being tested?
- Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Aug 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Children who are visually impaired
- Children who are hearing impaired
- Children who receive hydrotherapy every day of their rehabilitation program
Trial locations and contacts
1 site in 1 country.
Israel1 site
Alyn Pediatric and Adolescent Rehabilitation Center
Jerusalem, 91090
About this study
Official title: Hybrid Approach (In-person and Remote) to Pediatric Rehabilitation: A Look Beyond the Corona Crisis 2019
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.
Read more
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.
Read the detailed description
Scientific background: Children and youth recovering from acquired injuries receive therapy via in-patient or outpatient rehabilitation (OPR). Families from the periphery are required to invest time and money to get treatment. In the last decade, evidence for the effectiveness of remote (online) rehabilitation has grown. During the first four months of the COVID-19 pandemic, remote rehabilitation services were provided at Sheba and Alyn Medical Centers with demonstrated feasibility and satisfaction. Nevertheless, most rehabilitation services returned to in-person treatment. Objectives: To develop, implement and evaluate hybrid OPR for youth including a) identification of facilitators and barriers to hybrid service adoption; b) development of a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy; c) compare hybrid rehabilitation to in-person rehabilitation at two rehabilitation centers in Israel in terms of (1) adherence to therapy, (2) therapeutic alliance and (3) perceived quality of care (families and therapists), (4) functional effectiveness as measured by pre-post change in the PEDI, (5) cost-effectiveness of hybrid therapy (by comparing financial versus effectiveness outcomes) in the healthcare system (hospitals, health maintenance organizations), including training requirements, physical space requirements and cost. d) provide best practice recommendations for hybrid rehabilitation in children.
Working hypotheses: 1) Carrying out research at two major rehabilitation centers will enable identification of target populations for hybrid rehabilitation programs, assessment of the required resources and provision of solutions to identified barriers; 2) families and caregivers will express positive attitudes toward hybrid rehabilitation.3) the hybrid program will be cost-effective in terms of direct and indirect costs.
Research Methods: Focus groups of experts will develop a two-month hybrid program offered to all children (~200) in OPR commencing one month after in-person rehabilitation. Therapy adherence, therapeutic alliance and perceived quality of care will be examined monthly and compared to in-person treatment. Insight will be used to formulate best practice guidelines for hybrid telerehabilitation.
Data Collection: Thematic analysis will be used to analyze focus groups information. Data on measures of adherence, therapeutic alliance and perceived quality of care will be compared between hybrid and in-person programs. A difference-in-difference approach will assess differences in function between in-person and remote therapy. Cost estimates will compare direct and indirect services per child for in-person versus remote rehabilitation.
Importance of research: This study will be among the first to examine implementation of a hybrid program as recommended by the Ministry of Health (MOH) 'Remote Medicine' (6/2019, section 4.4). Utilizing the demonstrated benefits and infrastructure developed for remote rehabilitation during Corona pandemic , this research will help to uphold a basic principle in the State Health Insurance Law - ensuring accessible and quality health services throughout the country.
Possible recommendations for policy makers: Best practices for hybrid rehabilitation programs will enable policy makers to make quality rehabilitation services more accessible nationwide.
- Conditions
- Cerebral Palsy, Traumatic Brain Injury, Orthopedic Disorder
- Being tested
- Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis
- Keywords
- Occupational Therapy, Physical Therapy, Speech and Language Pathology, Psychology, Telerehabilitation, Hybrid Rehabilitation
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Traumatic, Musculoskeletal Diseases, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisisOther
Hybrid rehabilitation. Out patients will receive one day a week of remote therapy and the remaining (1-4 days) in person at rehabilitation hospital
| Study group | Role | What they receive |
|---|---|---|
| Hybrid rehabilitation | Experimental | Children will receive one day of remote rehabilitation. All other days children will receive therapy at hospital Receives: Other: Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Aug 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Control group and Intervention group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Naomi Gefen, Alyn Pediatric & Adolescent Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547762
- Sponsor's protocol ID
- 063-22
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Approach (In-person and Remote) to Pediatric Rehabilitation: A Look Beyond the Corona Crisis 2019
- ClinicalTrials.gov ID
- NCT06547762
- Acronym / sponsor ID
- 063-22
- Conditions
- Cerebral Palsy, Traumatic Brain Injury, Orthopedic Disorder
- Keywords
- Occupational Therapy, Physical Therapy, Speech and Language Pathology, Psychology, Telerehabilitation, Hybrid Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scientific background: Children and youth recovering from acquired injuries receive therapy via in-patient or outpatient rehabilitation (OPR). Families from the periphery are required to invest time and money to get treatment. In the last decade, evidence for the effectiveness of remote (online) rehabilitation has grown. During the first four months of the COVID-19 pandemic, remote rehabilitation services were provided at Sheba and Alyn Medical Centers with demonstrated feasibility and satisfaction. Nevertheless, most rehabilitation services returned to in-person treatment. Objectives: To develop, implement and evaluate hybrid OPR for youth including a) identification of facilitators and barriers to hybrid service adoption; b) development of a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy; c) compare hybrid rehabilitation to in-person rehabilitation at two rehabilitation centers in Israel in terms of (1) adherence to therapy, (2) therapeutic alliance and (3) perceived quality of care (families and therapists), (4) functional effectiveness as measured by pre-post change in the PEDI, (5) cost-effectiveness of hybrid therapy (by comparing financial versus effectiveness outcomes) in the healthcare system (hospitals, health maintenance organizations), including training requirements, physical space requirements and cost. d) provide best practice recommendations for hybrid rehabilitation in children.
Working hypotheses: 1) Carrying out research at two major rehabilitation centers will enable identification of target populations for hybrid rehabilitation programs, assessment of the required resources and provision of solutions to identified barriers; 2) families and caregivers will express positive attitudes toward hybrid rehabilitation.3) the hybrid program will be cost-effective in terms of direct and indirect costs.
Research Methods: Focus groups of experts will develop a two-month hybrid program offered to all children (~200) in OPR commencing one month after in-person rehabilitation. Therapy adherence, therapeutic alliance and perceived quality of care will be examined monthly and compared to in-person treatment. Insight will be used to formulate best practice guidelines for hybrid telerehabilitation.
Data Collection: Thematic analysis will be used to analyze focus groups information. Data on measures of adherence, therapeutic alliance and perceived quality of care will be compared between hybrid and in-person programs. A difference-in-difference approach will assess differences in function between in-person and remote therapy. Cost estimates will compare direct and indirect services per child for in-person versus remote rehabilitation.
Importance of research: This study will be among the first to examine implementation of a hybrid program as recommended by the Ministry of Health (MOH) 'Remote Medicine' (6/2019, section 4.4). Utilizing the demonstrated benefits and infrastructure developed for remote rehabilitation during Corona pandemic , this research will help to uphold a basic principle in the State Health Insurance Law - ensuring accessible and quality health services throughout the country.
Possible recommendations for policy makers: Best practices for hybrid rehabilitation programs will enable policy makers to make quality rehabilitation services more accessible nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Control group and Intervention group
| Arm | Type | Receives |
|---|---|---|
| Hybrid rehabilitation | Experimental | Other: Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisisChildren will receive one day of remote rehabilitation. All other days children will receive therapy at hospital |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Children who are visually impaired
- Children who are hearing impaired
- Children who receive hydrotherapy every day of their rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisisHybrid rehabilitation. Out patients will receive one day a week of remote therapy and the remaining (1-4 days) in person at rehabilitation hospital | Other | Hybrid rehabilitation |
Primary outcome
Adherence to therapy
Time frame: 2 months
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.
Therapeutic alliance
Time frame: 2 months
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.
Perceived quality of care- therapists
Time frame: 2 months
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.
Perceived quality of care- families
Time frame: 2 months
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
Cost-effectiveness of hybrid therapy
Time frame: 2 months
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
1 secondary outcome
Improved Function
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis in people with Cerebral Palsy and Traumatic Brain Injury, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to therapy (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.