Geriatric PatientsNCT06390800
Personalized Motor Learning in Primary Care Physiotherapy (TREAT)
An observational study of Geriatric Patients and Neurological Disorder, run by Zuyd University of Applied Sciences at 1 site in Netherlands.
Trial summary
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Geriatric Patients, Neurological Disorder
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2023to 15 Mar 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy working physiotherapist will be included for this study to help evaluate the card set and website
Physiotherapists will be eligible for inclusion when they:
- have at least one year of working experience
- are treating neurological and/or geriatric patients
- are able to attend the preparatory training provided by the researchers
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Zuyd University of Applied Sciences
Heerlen, Limburg, 6419 DJ
About this study
Official title: Personalized Motor Learning in Primary Care Physiotherapy; A Prospective Formative Process Evaluation
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed.
The aim of this prospective study is to evaluate the use and experiences of the card set and website designed to aid the physiotherapist in decision making with regards to motor learning. The following research question is central to this evaluation: How are the developed card set and website used and experienced by physiotherapists in primary care during the treatment of patients with neurological or geriatric conditions?
Read the detailed description
Method: Formative process evaluation.
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed. Participating physiotherapists will use the "card set and website" in their daily practice for a period of six months. To assess the usage and experiences of therapists, digital questionnaires will be administered prior to the intervention, at 3 months, and at 6 months, along with bi-weekly monitoring. The quantitative data from the questionnaires and monitoring will be analyzed using descriptive statistics (e.g., frequency tables, means, medians, IQR, and summary figures). Additionally, an interim evaluation will take place where solutions for the main user issues will be collectively brainstormed with the participants. Finally, a consensus meeting will be held to reach the final versions of the card set and website. The nominal group technique will be used to ensure active participation from all participants and to achieve consensus on the definitive list of modifications.
- Conditions
- Geriatric Patients, Neurological Disorder
- Medical subject headings
- Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
A qualitative questionnaire will be filled in three times throughout the study. This questionnaire inquires participants' experience regarding the card set and website.
Measured: Six months
Monitor
A quantitative questionnaire will be filled in biweekly. This questionnaire assesses the frequency of usage of the card set and website
Measured: Six months
Midterm evaluation
This meeting will be held to further specify and solve user problems. During this in-person session, problems that arise during the usage of the material will be discussed in depth under supervision from an experienced researcher. The meeting will be audio recorded whereafter it will be transcribed and analyzed into clusters and themes.
Measured: At three months into the study
Consensus meeting
The goal of this meeting is to reach a final version of the card set and website based on the experiences from the process evaluation. During the in-person session, a nominal group method will ensure consensus regarding possible changes to the material and future directions the material should take e.g., more emphasis on the analogue or digital component or implementation into education. Through communal voting participants will make decisions regarding possible solutions or directions of the material. The session will be audio recorded and transcribed for analysis.
Measured: At six months into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start6 Sep 2023
- Primary completion26 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyd University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Fysio Bunde, Fysio Regtop, Fysiotherapie zesgehuchten, Fysiotherapie Veldhoven zuyd, Fysiotherapie ART-health, Fysio van het Hoof, Fysiotherapie Corine Cuijpers, Frank Helgers, Fysiotherapie Kemps-Rijf, Cerfontaine&vanderLoop, Fysiotherapie Denssana, Maastricht Universitair Medisch Centrum, Regieorgaan SIA, Brunel University London, Fontys Paramedische Hogeschool, Kennisnetwerk CVA Nederland, Koninklijk Nederlands Genootschap voor Fysiotherapie (KNGF)
- Responsible party
- Sponsor
- Investigators
- Li-Juan Jie, PhD, Principal investigator, Zuyd University of Applied SciencesGuus Rothuizen, MSc, Principal investigator, Zuyd University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390800
- Sponsor's protocol ID
- METCZ20230061
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kleynen M, Beurskens A, Olijve H, Kamphuis J, Braun S. Application of motor learning in neurorehabilitation: a framework for health-care professionals. Physiother Theory Pract. 2020 Jan;36(1):1-20. doi: 10.1080/09593985.2018.1483987. Epub 2018 Jun 19.
PubMed 29920128
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Motor Learning in Primary Care Physiotherapy; A Prospective Formative Process Evaluation
- ClinicalTrials.gov ID
- NCT06390800
- Acronym / sponsor ID
- METCZ20230061
- Conditions
- Geriatric Patients, Neurological Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zuyd University of Applied SciencesUniversity, hospital or other
- Collaborators
- Fysio Bunde, Fysio Regtop, Fysiotherapie zesgehuchten, Fysiotherapie Veldhoven zuyd, Fysiotherapie ART-health, Fysio van het Hoof, Fysiotherapie Corine Cuijpers, Frank Helgers, Fysiotherapie Kemps-Rijf, Cerfontaine&vanderLoop, Fysiotherapie Denssana, Maastricht Universitair Medisch Centrum, Regieorgaan SIA, Brunel University London, Fontys Paramedische Hogeschool, Kennisnetwerk CVA Nederland, Koninklijk Nederlands Genootschap voor Fysiotherapie (KNGF)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 30 Apr 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.
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed.
The aim of this prospective study is to evaluate the use and experiences of the card set and website designed to aid the physiotherapist in decision making with regards to motor learning. The following research question is central to this evaluation: How are the developed card set and website used and experienced by physiotherapists in primary care during the treatment of patients with neurological or geriatric conditions?
Detailed description
Method: Formative process evaluation.
Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed. Participating physiotherapists will use the "card set and website" in their daily practice for a period of six months. To assess the usage and experiences of therapists, digital questionnaires will be administered prior to the intervention, at 3 months, and at 6 months, along with bi-weekly monitoring. The quantitative data from the questionnaires and monitoring will be analyzed using descriptive statistics (e.g., frequency tables, means, medians, IQR, and summary figures). Additionally, an interim evaluation will take place where solutions for the main user issues will be collectively brainstormed with the participants. Finally, a consensus meeting will be held to reach the final versions of the card set and website. The nominal group technique will be used to ensure active participation from all participants and to achieve consensus on the definitive list of modifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy working physiotherapist will be included for this study to help evaluate the card set and website
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire
Time frame: Six months
A qualitative questionnaire will be filled in three times throughout the study. This questionnaire inquires participants' experience regarding the card set and website.
Monitor
Time frame: Six months
A quantitative questionnaire will be filled in biweekly. This questionnaire assesses the frequency of usage of the card set and website
Midterm evaluation
Time frame: At three months into the study
This meeting will be held to further specify and solve user problems. During this in-person session, problems that arise during the usage of the material will be discussed in depth under supervision from an experienced researcher. The meeting will be audio recorded whereafter it will be transcribed and analyzed into clusters and themes.
Consensus meeting
Time frame: At six months into the study
The goal of this meeting is to reach a final version of the card set and website based on the experiences from the process evaluation. During the in-person session, a nominal group method will ensure consensus regarding possible changes to the material and future directions the material should take e.g., more emphasis on the analogue or digital component or implementation into education. Through communal voting participants will make decisions regarding possible solutions or directions of the material. The session will be audio recorded and transcribed for analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 29920128Kleynen M, Beurskens A, Olijve H, Kamphuis J, Braun S. Application of motor learning in neurorehabilitation: a framework for health-care professionals. Physiother Theory Pract. 2020 Jan;36(1):1-20. doi: 10.1080/09593985.2018.1483987. Epub 2018 Jun 19.
- The developed website to be evaluated in this projectLink provided by the sponsor.
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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.
Li-Juan Jie, PhD principal investigator
Zuyd University of Applied Sciences
Guus Rothuizen, MSc principal investigator
Zuyd University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Patients and Neurological Disorder, run by Zuyd University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionnaire (time frame: Six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390800, which also lists 1 linked publication.
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 30 Apr 2024.