On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
NCT ID: NCT03944486
Last Updated: 2024-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-08-13
2021-03-31
Brief Summary
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Population - stroke patients over 18 years old.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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On-Track
Stroke survivors receiving the OnTrack intervention for 12 weeks consisting of arm activity tracking and self-management coaching. Assessments are done before and after the intervention.
Feasibility of OnTrack
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Interventions
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Feasibility of OnTrack
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Eligibility Criteria
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Inclusion Criteria
* Stroke diagnosis less than 6 months previously (first or recurrent). Some participants will be recruited from an in-patient rehabilitation ward, hence the 6-month poststroke limit.
* Arm impairment of any type or level (including weakness-including dense hemiplegia, neglect and sensory deficits). This enables better understanding of which impairment level groups could benefit or not from using the intervention, especially considering the impact it may have on people's motivation regardless of their level of impairment.
* Ability to provide informed consent.
* Reliability to communicate (verbally or non-verbally) and understand English.
* Ability to read a predefined short message.
Exclusion Criteria
* Self-reported 'severe' pain in the arm affected either at rest or during movement.
* Severe oedema in the arm affected by their stroke, judged by the consenting therapist.
* Known discharge plans to a hospital other than the recruitment site or residential care in less than 7 weeks (a small proportion of patients in in-patient rehab may be in hospital for up to 12 weeks).
* Participants who are unable to engage with the intervention for a period of more than 7 consecutive days will be reviewed in a case-by-case basis by the members of the team responsible for delivering the intervention to determine if study continuation is appropriate.
18 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Ara Darzi, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial Collage NHS Healthcare Trust
London, , United Kingdom
Countries
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References
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Taylor E, Fusari G, Darzi A, Jones F. Is a novel digital system for arm and hand rehabilitation suitable for stroke survivors? A qualitative process evaluation of OnTrack. BMJ Open. 2023 Aug 18;13(8):e062119. doi: 10.1136/bmjopen-2022-062119.
Fusari G, Gibbs E, Hoskin L, Lawrence-Jones A, Dickens D, Fernandez Crespo R, Leis M, Crow J, Taylor E, Jones F, Darzi A. What is the feasibility and patient acceptability of a digital system for arm and hand rehabilitation after stroke? A mixed-methods, single-arm feasibility study of the 'OnTrack' intervention for hospital and home use. BMJ Open. 2022 Sep 28;12(9):e062042. doi: 10.1136/bmjopen-2022-062042.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19SM5146
Identifier Type: -
Identifier Source: org_study_id
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