Clinical trial NCT03944486: On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
Official title: Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Cerebrovascular Accident
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2019-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
timeFrame: Week 13
measure: Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
timeFrame: Week 13
Secondary outcomes:
measure: Modified Rankin Scale
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Unilateral Spatial Neglect (USN) (Aka Albert's Test)
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: System Usability Scale (SUS)
timeFrame: Week 13
measure: Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Motor Assessment Log (MAL) - Questionnaire
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Visual Analogue Scale for Pain - Question
timeFrame: Baseline, follow-up (week 7), follow-up (week 13)
measure: Friends and Family Test
timeFrame: Week 13
measure: EQ 5D 5L (Health Related Quality of Life)
timeFrame: Baseline, week 7, week 13
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Collage NHS Healthcare Trust
Study officials:
affiliation: Imperial College London
name: Ara Darzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.