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出境医 / 临床实验 / On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
Study Description
Brief Summary:
Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.
Population - stroke patients over 18 years old.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebrovascular Accident | Other: Feasibility of On-Track | Not Applicable |
Detailed Description:
TITLE Feasibility study of On Track - a digital system for upper limb rehabilitation after stroke
DESIGN & METHODS Mixed methods
Aims Assess the feasibility of 'On-Track' (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services.
OUTCOME MEASURES Various. (including functional and self-reported measures)
POPULATION Stroke survivors, their family/carers, clinicians, professionals and lay people working with stroke survivors.
ELIGIBILITY Participants will be stroke survivors, relatives/carers of stroke survivors, frontline healthcare workers who treat stroke survivors, managers responsible for stroke service provision and lay people with an involvement in stroke care/delivery.
Participants will be over 18.
DURATION 1- 2 years
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke |
| Actual Study Start Date : | August 13, 2019 |
| Estimated Primary Completion Date : | July 2020 |
| Estimated Study Completion Date : | July 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
On-Track
One arm feasibility study
|
Other: Feasibility of On-Track
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
|
Outcome Measures
Primary Outcome Measures :
- Feasibility of On-Track to patients assessed by semi structured interviews [ Time Frame: 12 months ]Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of On-Track
Other Outcome Measures:
- Feasibility of On-Track to therapists assessed by semi structured interviews [ Time Frame: 12 months ]To assess the feasibility of the study design and procedures. Semi structured interviews will aim to collect therapists opinions on the strengths and weaknesses of On-Track.
- Fugl-Meyer - a physical test of a stroke patients functional arm ability e.g. their strength and coordination. [ Time Frame: 12 months ]This outcome measure assesses physical function of a stroke patients arm
- Patient Activation and Motivation (PAM) - questionnaire 10-13 short questions [ Time Frame: 12 months ]PAM assesses a patient activation and motivation
- Motor Assessment Log (MAL) - questionnaire [ Time Frame: 12 months ]MAL - ask patients questions on their opinion about how much and how well they are using their stroke affected arm
- Visual Analogue Scale for pain - question [ Time Frame: 12 months ]Ask patients to rate their arm pain on a scale of 0-10
- Friends and Family test = a question [ Time Frame: 12 months ]Asks patient if they would recommend the service they have just received to friends/family
- EQ 5D 5L - questionnaire [ Time Frame: 12 months ]Asks approx. 5 short questions to patients assessing their quality of life
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult Stroke Survivor with arm impairment from the stroke.
- Able to give informed consent and communicate reliably.
- Able to read
Exclusion Criteria:
- Patients with severe arm pain or swelling.
Contacts and Locations
Contacts
| Contact: Gianpaolo Fusari | 07767786778 | gianpaolo@helixcentre.com |
Locations
| United Kingdom | |
| Imperial Collage NHS Healthcare Trust | Recruiting |
| London, United Kingdom, W12 0HS | |
| Contact: Ara Darzi a.darzi@nhs.net | |
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
| Principal Investigator: | Ara Darzi, MD | Imperial College London |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 9, 2019 | ||||
| Last Update Posted Date | August 15, 2019 | ||||
| Actual Study Start Date ICMJE | August 13, 2019 | ||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility of On-Track to patients assessed by semi structured interviews [ Time Frame: 12 months ] Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of On-Track
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures |
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | On-Track Feasibility Study of a Rehabilitation System for Stroke Patients | ||||
| Official Title ICMJE | Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke | ||||
| Brief Summary |
Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke. Population - stroke patients over 18 years old. |
||||
| Detailed Description |
TITLE Feasibility study of On Track - a digital system for upper limb rehabilitation after stroke DESIGN & METHODS Mixed methods Aims Assess the feasibility of 'On-Track' (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services. OUTCOME MEASURES Various. (including functional and self-reported measures) POPULATION Stroke survivors, their family/carers, clinicians, professionals and lay people working with stroke survivors. ELIGIBILITY Participants will be stroke survivors, relatives/carers of stroke survivors, frontline healthcare workers who treat stroke survivors, managers responsible for stroke service provision and lay people with an involvement in stroke care/delivery. Participants will be over 18. DURATION 1- 2 years |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
| Condition ICMJE | Cerebrovascular Accident | ||||
| Intervention ICMJE | Other: Feasibility of On-Track
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
|
||||
| Study Arms ICMJE | On-Track
One arm feasibility study
Intervention: Other: Feasibility of On-Track
|
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| Publications * | Fusari G, Gibbs E, Hoskin L, Dickens D, Leis M, Taylor E, Jones F, Darzi A. Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke. BMJ Open. 2020 Mar 23;10(3):e034936. doi: 10.1136/bmjopen-2019-034936. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
24 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 2020 | ||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03944486 | ||||
| Other Study ID Numbers ICMJE | 19SM5146 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Imperial College London | ||||
| Study Sponsor ICMJE | Imperial College London | ||||
| Collaborators ICMJE | Imperial College Healthcare NHS Trust | ||||
| Investigators ICMJE |
|
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| PRS Account | Imperial College London | ||||
| Verification Date | August 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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