On-Track Feasibility Study of a Rehabilitation System for Stroke Patients

NCT ID: NCT03944486

Last Updated: 2024-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2021-03-31

Brief Summary

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Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.

Population - stroke patients over 18 years old.

Detailed Description

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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

Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

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.

Group Type OTHER

Feasibility of OnTrack

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 18 or over).
* 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

* Unstable medical condition.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 37597873 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36171046 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32205375 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19SM5146

Identifier Type: -

Identifier Source: org_study_id

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