StrokeNCT05674162
Observer Reactivity During Gait Measurements in a Clinical Setting
A study testing Unobserved, Observed and Unobserved & Measured in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. Although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Unobserved, Observed and Unobserved & Measured
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute or chronic stroke (>3 months ago)
Who cannot join
- Not able to walk 50 meters without resting.
- Not able to understand instructions given by the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. Although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that are performed as part of clinical care. Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes and most studies examined the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking, and observed walking combined with awareness of measurement, in a within-subjects repeated measures design.
Read the detailed description
Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration in behaviour as a consequence of observation or awareness of measurement. It is believed that this could influence research outcomes in prospective experimental and observational studies. However, as described in a recent systematic review, the extend of the effect on research outcomes is still debated. The available studies on observer reactivity with various populations and tasks generate contradicting findings and conclusions. Especially within the health sciences, more research is necessary as observer reactivity may confound study results in the direction of better health outcomes.
Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes. For example, some studies showed a higher walking velocity and better gait symmetry under observation, while others showed an opposite effect. This may be caused by the variation in diagnosis group between the studies or small sample sizes. Because of these mixed results and the low number of studies available on this topic, there is yet no consensus on a generalizable effect of observation during gait measurements. Furthermore, most studies examine the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals.
For clinical decision making, it is essential to investigate whether gait measurements are representative for the actual gait pattern of the patient. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking by a researcher, and observed walking combined with awareness of measurement by sensors.
- Conditions
- Stroke
- Being tested
- Unobserved, Observed, Unobserved & Measured
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnobservedBehavioural
Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher.
ObservedBehavioural
Participants walk a distance of 40 meters wearing the sensors, observed by the researcher.
Unobserved & MeasuredRadiation
Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher and aware of the gait measurement by the sensors.
| Study group | Role | What they receive |
|---|---|---|
| Gait measurement | Experimental | Use of four accellerometers/sensors (1 on each foot, one on the lumbar area and one on the sternum) that measure gait parameters during walking. Receives: Behavioral: Unobserved; Behavioral: Observed; Radiation: Unobserved & Measured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
Mean walking speed (meters/second)
Measured: 5 minutes
Secondary outcomes (8)
Stride length
Mean stride length (meters)
Measured: 5 minutes
Cadance
Cadance (steps/minute)
Measured: 5 minutes
Stance time symmetry
Symmetry in stance time between paretic and non-paretic leg
Measured: 5 minutes
Swing time symmetry
Symmetry in swing time between paretic and non-paretic leg
Measured: 5 minutes
percent single leg stance
percent single leg stance of the total gait cycle of the paretic leg
Measured: 5 minutes
percent single leg stance symmetry
Symmetry in percent single leg stance between paretic and non-paretic leg
Measured: 5 minutes
Stride length variability
Variability in stride length
Measured: 5 minutes
Swing time variability
Variability in swing time of the paretic leg
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jan 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, repeated measures model.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël LW Keijsers, PhD, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674162
- Sponsor's protocol ID
- 1042_TZO_Observer Reactivity
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer Reactivity During Gait Measurements in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05674162
- Acronym / sponsor ID
- 1042_TZO_Observer Reactivity
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Jan 2023 (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.
Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. Although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that are performed as part of clinical care. Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes and most studies examined the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking, and observed walking combined with awareness of measurement, in a within-subjects repeated measures design.
Detailed description
Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration in behaviour as a consequence of observation or awareness of measurement. It is believed that this could influence research outcomes in prospective experimental and observational studies. However, as described in a recent systematic review, the extend of the effect on research outcomes is still debated. The available studies on observer reactivity with various populations and tasks generate contradicting findings and conclusions. Especially within the health sciences, more research is necessary as observer reactivity may confound study results in the direction of better health outcomes.
Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes. For example, some studies showed a higher walking velocity and better gait symmetry under observation, while others showed an opposite effect. This may be caused by the variation in diagnosis group between the studies or small sample sizes. Because of these mixed results and the low number of studies available on this topic, there is yet no consensus on a generalizable effect of observation during gait measurements. Furthermore, most studies examine the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals.
For clinical decision making, it is essential to investigate whether gait measurements are representative for the actual gait pattern of the patient. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking by a researcher, and observed walking combined with awareness of measurement by sensors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, repeated measures model.
| Arm | Type | Receives |
|---|---|---|
| Gait measurement | Experimental | Behavioral: Unobserved, Behavioral: Observed, Radiation: Unobserved & MeasuredUse of four accellerometers/sensors (1 on each foot, one on the lumbar area and one on the sternum) that measure gait parameters during walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subacute or chronic stroke (>3 months ago)
Key exclusion criteria (2 listed)
- Not able to walk 50 meters without resting.
- Not able to understand instructions given by the researcher.
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 |
|---|---|---|
| UnobservedParticipants walk a distance of 40 meters wearing the sensors, unobserved by the researcher. | Behavioural | Gait measurement |
| ObservedParticipants walk a distance of 40 meters wearing the sensors, observed by the researcher. | Behavioural | Gait measurement |
| Unobserved & MeasuredParticipants walk a distance of 40 meters wearing the sensors, unobserved by the researcher and aware of the gait measurement by the sensors. | Radiation | Gait measurement |
Primary outcome
Gait velocity
Time frame: 5 minutes
Mean walking speed (meters/second)
8 secondary outcomes
Stride length
Time frame: 5 minutes
Cadance
Time frame: 5 minutes
Stance time symmetry
Time frame: 5 minutes
Swing time symmetry
Time frame: 5 minutes
percent single leg stance
Time frame: 5 minutes
percent single leg stance symmetry
Time frame: 5 minutes
Stride length variability
Time frame: 5 minutes
Swing time variability
Time frame: 5 minutes
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 13 Dec 2023.
- 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.
Noël LW Keijsers, PhD principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unobserved, Observed and Unobserved & Measured in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
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 1 inclusion and 2 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 13 Dec 2023. 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?
Gait velocity (time frame: 5 minutes). 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 13 Dec 2023.