StrokeNCT02504073
Clinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait
An observational study of Stroke, run by Technical University of Bern.
Trial summary
The goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: physiotherapists working with stroke patients
Who may be able to join
- chartered physiotherapists
- physiotherapists in training
- working with stroke patients
Who cannot join
- other languages than German
About this study
The goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait.
Read the detailed description
Physiotherapists don't usually use any assessments to evaluate gait but observe it without an instrument. The questions in this study are:
- what abnormalities can physiotherapists detect when observing a patient walking?
- what do they consider the main problem that has a negative effect on the patient's walking?
- what hypothesis do they generate?
- how is the inter-rater reliability for the "main problem" and the hypothesis?
- Conditions
- Stroke
- Being tested
- No intervention
- Keywords
- Clinical Reasoning, Physiotherapists
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| PT's working in stroke in NW-Switzerland | 54 Physiotherapists (PT's) working in north-west Switzerland (at Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach) are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.
There is no intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Gait Abnormalities Observed
The questionnaire will be the basis of this study as it will be the basis for open coding. It is handed out to 54 observers (=physiotherapists) and will be filled in 6 times (for 6 patient videos).
The questionnaire consists of 3 main questions:
- what gait abnormalities do you see?
- What do you consider the main problem (1 sentence)
- what is your hypothesis (max. 3) The question one delivers different items (each new observation is a new item) that were determined patient by patient and rater by rater by three independent researchers. They were then listed and categorised by consensus. Finally, the frequency of each item was analysed globally and for each patient.
Measured: up to 2 months
Number of Main Problems Observed
This outcome is a result of the second part of the Questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified the main statements from the sentences written. Items were afterwards categorised. Finally the frequency of each item was analysed globally and for each patient.
Measured: up to 2 months
Number of Hypotheses Observed
This outcome is a result of the third part of the questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified and categorised all the listed hypotheses from question number three of the questionnaire. After that the use frequency of each item was analysed globally and for each patient.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clare Maguire, Technical University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504073
- Sponsor's protocol ID
- EKNZ08/12/14
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2015
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait
- ClinicalTrials.gov ID
- NCT02504073
- Acronym / sponsor ID
- EKNZ08/12/14
- Conditions
- Stroke
- Keywords
- Clinical Reasoning, Physiotherapists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Technical University of BernUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait.
Detailed description
Physiotherapists don't usually use any assessments to evaluate gait but observe it without an instrument. The questions in this study are:
- what abnormalities can physiotherapists detect when observing a patient walking?
- what do they consider the main problem that has a negative effect on the patient's walking?
- what hypothesis do they generate?
- how is the inter-rater reliability for the "main problem" and the hypothesis?
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PT's working in stroke in NW-Switzerland | – | Other: No intervention54 Physiotherapists (PT's) working in north-west Switzerland (at Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach) are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced. There is no intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- physiotherapists working with stroke patients
Key inclusion criteria (3 listed)
- chartered physiotherapists
- physiotherapists in training
- working with stroke patients
Key exclusion criteria (1 listed)
- other languages than German
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 |
|---|---|---|
| No interventionNo intervention | Other | PT's working in stroke in NW-Switzerland |
Primary outcome
Number of Gait Abnormalities Observed
Time frame: up to 2 months
The questionnaire will be the basis of this study as it will be the basis for open coding. It is handed out to 54 observers (=physiotherapists) and will be filled in 6 times (for 6 patient videos). The questionnaire consists of 3 main questions: 1. what gait abnormalities do you see? 2. What do you consider the main problem (1 sentence) 3. what is your hypothesis (max. 3) The question one delivers different items (each new observation is a new item) that were determined patient by patient and rater by rater by three independent researchers. They were then listed and categorised by consensus. Finally, the frequency of each item was analysed globally and for each patient.
Number of Main Problems Observed
Time frame: up to 2 months
This outcome is a result of the second part of the Questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified the main statements from the sentences written. Items were afterwards categorised. Finally the frequency of each item was analysed globally and for each patient.
Number of Hypotheses Observed
Time frame: up to 2 months
This outcome is a result of the third part of the questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified and categorised all the listed hypotheses from question number three of the questionnaire. After that the use frequency of each item was analysed globally and for each patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Technical University of Bern.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Gait Abnormalities Observed (time frame: up to 2 months). The study lists 3 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 2 Aug 2017.