Research With Clinical Staff in Stroke RehabilitationNCT05330234

Usability Study of OnTrack Tools

A study testing OnTrack Tools in people with Research With Clinical Staff in Stroke Rehabilitation, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Aims: Assess the usability of OnTrack Tools, a clinician facing interface to manage stroke survivors using the OnTrack rehabilitation system. Background: Arm disability is a common problem after stroke that can lead to loss of independence, it affects ~450,000 people in the UK. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Research With Clinical Staff in Stroke Rehabilitation
What is being tested?: OnTrack Tools
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited Kingdom
Study dates: 12 May 2022to 30 Jun 2022
Phase: Interventional
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult (18 years old or over) Occupational Therapists and Physiotherapists (Band 4 to Band 8) working in the stroke wards at ICHT.

Who cannot join

No exclusion criteria has been defined.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College Healthcare NHS Trust
London, W2 1NY

Other trials in United Kingdom

About this study

Official title: Usability Study of OnTrack Tools: a Study to Assess the Usability of a Clinician-facing Software Application to Support Arm Rehabilitation After Stroke.

~450,000 people in the UK. Repetitive activity is critical for recovery but research shows people can struggle with intensity and keeping track of progress. The OnTrack system being developed at Imperial College London is a potential solution to this problem. Intervention: The OnTrack system consists of two software applications, OnTrack App - used by patients, and OnTrack Tools - used by clinicians. OnTrack Tools pulls data generated by the OnTrack App and enables the monitoring of clients' arm activity, and management of goals and educational content. The software is used to inform selfmanagement coaching by helping therapists understand more about how and when patients use their affected arm between treatment sessions. Design and methods: This study will assess the usability of the OnTrack Tools component of the system. The study will recruit stroke therapists from Imperial College Healthcare NHS Trust to provide feedback on the experience and usability of OnTrack Tools' graphical user interface (GUI). The study will be divided into three progressive cycles of testing, feedback and iteration. Each cycle will see participants individually completing specific tasks related to system navigation and the management of patients under simulation. Participants will complete outcome measures and take part in focus groups. Researchers will analyse and use the feedback to improve the GUI ready for the next testing cycle. Patient and public involvement: The project team includes a PPIE group of stroke survivors who oversee the project and help us with public facing documentation. They are members of the research team and are reimbursed for their time and travel, according to INVOLVE guidance. Dissemination: Results of the study will be written-up for technical reporting and publication. Participants will be provided with a summary of results at the end of the study. The study team will be providing general updates on the progress of the study via their social media channels (e.g. Twitter @OnTrackRehab @ImperialIGHI @HelixCentre).

Conditions: Research With Clinical Staff in Stroke Rehabilitation
Being tested: OnTrack Tools
Keywords: stroke, rehabilitation, neurology, digital health
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OnTrack ToolsDevice
The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:
Phase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management.

Study groups in NCT05330234
Study group	Role	What they receive
Therapists	Other	Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards. Receives: Device: OnTrack Tools

What is being measured

The primary outcome is the main question the study is designed to answer.

System Usability Scale (Phase 1)
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.
The measure is scored on a 0-100 scale, a higher score means a better outcome.
Measured: Up to 60 days.
System Usability Scale (Phase 2)
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.
The measure is scored on a 0-100 scale, a higher score means a better outcome.
Measured: Up to 60 days
System Usability Scale (Phase 3)
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.
The measure is scored on a 0-100 scale, a higher score means a better outcome.
Measured: Up to 60 days.

Secondary outcomes (1)

Post-Study System Usability Questionnaire (PSSUQ)
The PSSUQ (Post-Study System Usability Questionnaire is a 16-item standardized questionnaire. It is widely used to measure users' perceived satisfaction of a website, software, system or product at the end of a study.
PSSUQ follows a 7-point Likert Scale (+ NA option).
1 is "strongly agree" and 7 is "strongly disagree"
Results are calculated by averaging the scores from the 7 points of the scale.
The PSSUQ has one overall score and 3 sub-scales, namely system usefulness, information quality, and interface quality scored as follows:
Overall: the average scores of questions 1 to 16 System Usefulness (SYSUSE): the average scores of questions 1 to 6 Information Quality (INFOQUAL): the average scores of questions 7 to 12 Interface Quality (INTERQUAL): the average scores of questions 13 to 15
The lower the scores, the better the performance and the higher the perceived satisfaction.
Measured: Up to 60 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 202230 Jun 2022

First posted15 Apr 2022
Study start12 May 2022
Primary completion30 Jun 2022
Study completion30 Jun 2022

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 Research With Clinical Staff in Stroke RehabilitationStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: This study aims to assess the usability of the OnTrack Tools GUI under simulation. The study follows up from a study of the OnTrack system that demonstrated the feasibility and acceptability of the patient-facing component of the system by stroke survivors and therapists. The design of this study was developed through a collaborative approach between the study researchers, patients, and front-line therapists. The OnTrack intervention is being developed by Imperial College, this usability study is part of the development process.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05330234
Sponsor's protocol ID: 22CX7578
Status last verified: Mar 2024
First submitted: 1 Apr 2022
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan for individual participant data to be shared.

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usability Study of OnTrack Tools: a Study to Assess the Usability of a Clinician-facing Software Application to Support Arm Rehabilitation After Stroke.
ClinicalTrials.gov ID: NCT05330234
Acronym / sponsor ID: 22CX7578
Conditions: Research With Clinical Staff in Stroke Rehabilitation
Keywords: stroke, rehabilitation, neurology, digital health
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: Imperial College Healthcare NHS Trust
Study start: 12 May 2022 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 15 Apr 2022 (actual)
Results: Posted 11 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study aims to assess the usability of the OnTrack Tools GUI under simulation. The study follows up from a study of the OnTrack system that demonstrated the feasibility and acceptability of the patient-facing component of the system by stroke survivors and therapists. The design of this study was developed through a collaborative approach between the study researchers, patients, and front-line therapists. The OnTrack intervention is being developed by Imperial College, this usability study is part of the development process.

Arm	Type	Receives
Therapists	Other	Device: OnTrack ToolsSingle arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult (18 years old or over) Occupational Therapists and Physiotherapists (Band 4 to Band 8) working in the stroke wards at ICHT.

Key exclusion criteria (1 listed)

No exclusion criteria has been defined.

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
OnTrack ToolsThe intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below: Phase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management.	Device	Therapists

Primary outcome

System Usability Scale (Phase 1)
Time frame: Up to 60 days.
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome.
System Usability Scale (Phase 2)
Time frame: Up to 60 days
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome.
System Usability Scale (Phase 3)
Time frame: Up to 60 days.
In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke[1] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems. The measure is scored on a 0-100 scale, a higher score means a better outcome.

1 secondary outcome

Post-Study System Usability Questionnaire (PSSUQ)
Time frame: Up to 60 days.

Results and safety

Results posted to the registry on 11 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapists	10	6

Primary outcome: System Usability Scale (Phase 1)

Time frame: Up to 60 days.. Mean (Full Range). Unit: score on a scale

Measure	Therapists (Phase 1) n = 10
Value	73.3 (62.5 to 90)

Primary outcome: System Usability Scale (Phase 2)

Time frame: Up to 60 days. Mean (Full Range). Unit: score on a scale

Measure	Therapists (Phase 2) n = 9
Value	78.3 (72.5 to 92.5)

Primary outcome: System Usability Scale (Phase 3)

Time frame: Up to 60 days.. Mean (Full Range). Unit: score on a scale

Measure	Therapists (Phase 3) n = 6
Value	77.1 (72.5 to 82.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: No adverse event data was collected for this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapists	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan for individual participant data to be shared.

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.

Ara Darzi principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OnTrack Tools in people with Research With Clinical Staff in Stroke Rehabilitation, run by Imperial College London at 1 site in United Kingdom.

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 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 18 Mar 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2024). 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?

System Usability Scale (Phase 1) (time frame: Up to 60 days.). 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?

On the ClinicalTrials.gov record for NCT05330234.

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 18 Mar 2024.