Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke
Phase: NA
Conditions: Cerebrovascular Accident
Sponsor: Imperial College London

OnTrack Feasibility Study 
 
 
 
Feasibility study of OnTrack - a digital system for 
upper limb rehabilitation after stroke  
 
 
 
 
 
V 1.3  
19-06-2019 
 
 
 
 
MAIN SPONSOR: Imperial College London  
FUNDERS: Helix Centre – Institute of Global Health Innovation & NIHR Imperial Biomedical 
Research Council 
STUDY COORDINATION CENTRE: Helix Centre – Institute of Global Health Innovation  
NRES reference:  
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

V 1.3 19-06-2019 IRAS Project ID 257058 
 
1 
Study Management Group 
 
Chief Investigator: Professor the Lord Ara Darzi 
Co-investigators: Professor Fiona Jones, Gianpaolo Fusari, Ella Gibbs, Lily Hoskin 
Statistician: Melanie Leis  
Study Management: Gianpaolo Fusari 
 
Study Coordination Centre  
 
Helix Centre within the Institute of Global Health Innovation, Imperial College London. 
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: Mr Gianpaolo Fusari 
Address: 3rd Floor, Paterson Building, St Mary's Hospital, Praed Street, London.  
 
Tel: 07767 792770  
 
 
 
 
 
 
 
E-mail: gianpaolo@helixcentre.com  
 
 
 
 
 
Web address: www.helixcentre.com 
 
Clinical Queries 
 
Clinical queries should be directed to Gianpaolo Fusari (gianpaolo@helixcentre.com / 07767 
792 770) who will direct the query to the appropriate person 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
Funder 
 
This project is funded by the Helix Centre and NIHR Imperial Biomedical Research Council 
 
This protocol describes a feasibility study for the OnTrack intervention and provides 
information about procedures for entering participants.  Every care was taken in its drafting, 
but corrections or amendments may be necessary. These will be circulated to investigators 
in the study.  Problems relating to this study should be referred, in the first instance, to the 
Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance 
Framework for Health and Social Care (2nd edition). It will be conducted in compliance with 
the protocol, the Data Protection Act and other regulatory requirements as appropriate.  
 

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Table of Contents 
 
1. INTRODUCTION  
4 
1.1. BACKGROUND 
4 
1.2. RATIONALE FOR CURRENT STUDY 
4 
2. STUDY OBJECTIVES 
5 
3. STUDY DESIGN 
5 
4. PARTICIPANT ENTRY  
9 
4.1 PRE-REGISTRATION EVALUATIONS  
9 
4.2 INCLUSION CRITERIA 
9 
4.3 EXCLUSION CRITERIA 
10 
4.4 WITHDRAWAL CRITERIA 
10 
4.5 DISTRESS PROTOCOL 
 
5. ASSESSMENT AND FOLLOW-UP  
10 
6. STATISTICS AND DATA ANALYSIS 
10 
7. REGULATORY ISSUES 
11 
7.1 ETHICS APPROVAL 
11 
7.2 CONSENT  
11 
7.3 CONFIDENTIALITY 
12 
7.4 INDEMNITY 
12 
7.5 SPONSOR 
12 
7.6 FUNDING 
12 
7.7 AUDITS  
12 
8. STUDY MANAGEMENT 
12 
9. PUBLICATION POLICY 
12 
10. REFERENCES 
12 
 
 
 
 
 
 
 
 
 

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KEYWORDS 
Stroke, Upper Limb Rehabilitation, Sensors, Behaviour 
 
STUDY SUMMARY 
 
TITLE Feasibility study of OnTrack - a digital system for upper limb 
rehabilitation after stroke  
DESIGN & METHODS Mixed methods 
AIMS Assess the feasibility of ‘OnTrack’ (a new arm rehabilitation system), 
for use by patients, and frontline staff in stroke rehabilitation services. 
OUTCOME 
MEASURES 
Various. (Including but not exclusive to: interviews; focus groups; 
usability questionnaires e.g. system usability scale; functional 
outcome measures e.g Fugl-Meyer; self-reported outcome 
measures e.g Motor Activity Log; motivational outcome measures 
e.g. Patient Activation Measure; and others such as e.g. Friends & 
Family Test, EQ-5D-5L, Modified Rankin Scale, Montreal 
Cognitive Assessment, etc.) 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. INTRODUCTION  
 
1.1. 
BACKGROUND 
 
There are over 100,000 strokes per year in the UK, and nearly 1.2 million stroke survivors, of 
these 25% occur in people under 65 years of age. Stroke is the leading cause of disability in 
the UK, and almost two thirds of stroke survivors leave hospital with a disability. Upper-limb 
weakness is the main cause of impairment, and significantly contributes to the loss of 
independence and isolation stroke survivors feel. Stroke is estimated to cost the NHS and 
social care in England as much as £1.7 billion per year (Stroke Association, 2017).  
Repetitive rehabilitation techniques are widely accepted as the ‘gold-standard’ for regaining 
ability after stroke (Kwakkel, 2004). Nonetheless, studies suggest that the actual time 
patients spend exercising is minimal (Kunkel, 2014). Many current approaches to solving 
this problem focus on improving the prescribed rehabilitation sessions, often employing 
gamification techniques (Laver, 2017 and Loureiro, 2011). Whilst this is important, there is 
untapped potential to increase repetitive rehabilitation by targeting the 90% of the day where 
patients are going about life’s daily activities.  
 
1.2 
RATIONALE FOR CURRENT STUDY 
 
During the ULRAS ethnographic study we identified that patients struggle to see and keep 
track of improvements, this impacts their motivation and leaves them dependent on a 
therapist for feedback. Patient often reported they felt unsupported after leaving hospital and 
didn’t know how to best help themselves improve their arm function. The feedback gathered 
from patients and clinicians during the ULRAS study was the basis for developing the 
OnTrack intervention.  
OnTrack is a rehabilitation system that uses smart-devices to track arm movement through 
accelerometry. It combines principles of behaviour change with data on arm movement to 
provide actionable insights and motivate individuals to increase their arm activity. OnTrack 
therapists provide regular follow-up consultations to support individuals.  
A proof-of-concept has been developed and tested with 10 individuals. A 20% mean 
increase of activity was observed, with one participant achieving 55% over seven weeks. 
Participants reported that after using OnTrack they were more aware of their impaired arm 
and had increased confidence in using it for new tasks.  
The proof-of-concept has been developed further through a process co-design with users; 
therapists and stroke survivor feedback has continued to be incorporated to define the 
intervention.  
OnTrack has the potential to be a scalable solution requiring minimal training that could be 
used in conjunction with NHS services to help increase the overall amount of arm 
rehabilitation received.  
A study to assess the feasibility of conducting a definitive randomised trial of the OnTrack 
rehabilitation system is now warranted. 
 
2. STUDY OBJECTIVES 
 
Objective 1: To assess the feasibility of the study design and procedures 
Objective 2. To explore implementation fidelity and acceptability of OnTrack 
 

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The feasibility study will enable the design of a definitive randomised controlled trial testing 
the effectiveness of OnTrack.   
 
3. STUDY DESIGN 
 
Feasibility study of OnTrack 
A 12-15 month study to assess the feasibility of conducting a definitive randomised trial of 
the OnTrack rehabilitation system. 
Study Design  
A feasibility study and nested process evaluation. The study will be non-randomised; this is 
a pragmatic solution to set-up, recruitment and delivery across one site within the specified 
timeframe. The purpose of the study is not to measure clinical effectiveness of the 
intervention, this will be addressed in a future study if the system proves to be clinically 
feasible. The design of the study was developed through a collaborative approach between 
the study researchers, patients, front-line therapists, and the NIHR RDS. 
A process evaluation will be completed in parallel to learn about usage and engagement 
mechanisms of participants, therapists and other frontline staff, providing critical information 
for implementation fidelity and impact mechanisms necessary for scale-up. 
Outcomes 
Feasibility outcomes including the percentage of patients eligible, recruited and completing 
the 14-week intervention.  
Clinical outcomes (such as Fugl-Meyer, Motor Activity Log, Patient Activation Measure, EQ-
5D-5L, Friends & Family test, Montreal Cognitive Assessment, Visual Analog Scale Pain, 
Rankin Scale, etc.) will be collected to identify an appropriate primary outcome, and to 
estimate parameters for a sample size calculation. 
Feasibility assessment criteria:  
1. ≥50% recruitment rate of eligible population 
2. ≥50% adherence 
3. ≥80% usability, measured by the System Usability Scale (SUS) 
4. ≥80% implementation fidelity of OnTrack 
5. Sample size estimate for a definitive RCT 
6. Indication of the best way to integrate OnTrack into the current rehabilitation environment 
Intervention  
The OnTrack system consists of smart-devices (smartphone and smartwatch) and therapist 
support. Smart-devices are used to track arm movement, receive motivational messages 
and provide a real-time display of completed arm activity. Therapist support is provided 
through fortnightly consultations. Additionally, OnTrack helps therapists understand more 
about how and when patients use their affected arm between treatments.   
 

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Recruitment 
Therapists will be responsible for identifying suitable patients. They will introduce the study 
to potential participants and provide information documents. Therapist will allow enough time 
(minimum 24 hours) for potential participants to think about the pros and cons of 
participating and to formulate questions. Therapists will be able to answer questions or will 
liaise with the research team to provide an answer. Once all questions are answered and a 
potential participant is happy to participate, consent will be taken by the therapist. Only at 
this stage will limited patient information be shared with the research team. There may be 
situations where a therapist is only able to take verbal consent from a participant due to time 
or material constraints, in such cases the researchers will be able to take written consent 
from the participant upon first meeting them.  
We plan to recruit 50% of the total eligible stroke population at Charing Cross. Aiming for 24-
38 patients to start the intervention, as advocated by feasibility literature (4). A 50% drop out 
rate is expected.  
Participants who are subsequently discharged home will be able to continue in the study. 
Frontline healthcare workers involved with patients that take part will be invited to take part 
in interviews and focus groups to discuss their feedback. 
Inclusion: Adult stroke survivors (< 6 months) with arm impairment (including weakness, 
neglect, sensory deficits), who can:  
● Provide informed consent 
● Reliably communicate (this could be verbal or non-verbal) 
● Read a short message (this is necessary as the intervention partly relies on the 
participants’ ability to read short messages) 
Exclusion: We are unable to recruit participants who at the time of recruitment are 
experiencing severe pain or oedema in the arm affected by their stroke. This is because 
their course of rehabilitation is different from a stroke survivor who isn’t affected by these 
conditions, hence a comparison between samples would be impossible.  
Dose 
Participants will be involved in the study for 14 weeks.  
Participants will be loaned equipment needed for the study. 
Week 0: Participants will wear activity trackers on both arms to gather a baseline of activity 
allowing left-to-right comparison and complete outcome measures.  
Weeks 1-12: Participants will wear a smartwatch on their impaired arm only. They will 
receive real-time feedback on the amount of movement completed (measured in minutes) 
and daily motivational messages. Participants will receive regular consultations 
(approximately every two weeks) with an OnTrack researcher. During the consultation any 
problems will be addressed and feedback gained.  
At the start of week 13 patients will be given two activity trackers to wear again for 1 week to 
reassess their amount of movement.  
Weeks 7 and 13: Repeat outcome measures. 
Week 14: Usability questionnaires and semi-structured interviews administered. 

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Example messages include: 
• 
“Hello, it’s the start if a new week, let’s continue to track your arm activity. If you 
haven’t already, put on the watch and press the blue START button to begin tracking. 
Are you ok to do this now?” 
• 
“Hi, did you know about the Stroke Association? They have a wealth of resources for 
you, check them out by following this link” 
• 
“Hello, let’s keep it simple during the weekend and stick to focusing on reaching your 
60 minutes of activity” 
Therapist involvement 
Additionally, at the start of the participant’s involvement with the study, the therapists will 
provide information on their goals. Therapists will also have a ‘check-in’ call or email with 
researchers every 1-2 weeks to update the researchers on the participant’s progress. 
Additionally they will be invited to take part in an interview/focus group to discuss their 
experience of OnTrack. 
Other frontline healthcare staff 
Will be invited to take part in interviews and or focus groups to discuss their experience of 
OnTrack. 
Patients family/carer 
These individuals will be invited to share their thoughts and experiences of OnTrack with the 
researchers.   
For all participants 
Sessions, interviews and focus groups may be audio recorded. Data will be anonymised as 
far as possible and sent to a transcription service. There may be instances where 
interviewees and/or session participants use someone’s name and this could be difficult to 
anonymise. 
Analysis  
Analysis will be completed on the parameters and implementation of the study in addition to 
the usability of OnTrack.  
Data collected for the process evaluation will capture changes over time and will be a 
combination of qualitative data from interviews with stroke participants, physiotherapists and 
frontline staff to explore their experiences of using OnTrack, as well as quantitative data on 
usage of OnTrack and the self-reported SUS. OnTrack therapy support sessions will be 
monitored through a fidelity checklist and observations. Interview data will undergo thematic 
analysis. 
Data will be analysed for any association between the feasibility of the intervention and 
stroke subtype, patient demographics, stroke disability, and the amount of physiotherapy 
patients receive during the intervention period. 
 
Other 
The list of outcome measures provided is not exhaustive and others may be used instead or 
in addition to the ones listed above.  

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Participants, with their consent, may be videoed or photographed at any point during the 
study. This data may be used for further development and/or dissemination (anonymised 
images/videos). 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
 
There will be no pre-registration evaluations necessary for eligible participants to be included 
in the study. 
 
4.2 
INCLUSION CRITERIA 
 
Adult stroke survivors with arm impairment (including weakness, neglect, sensory deficits), 
who can:  
﹣ 
Cognitively able to provide informed consent (advice will be gained from the patients 
therapy team if researchers are in any doubt) 
﹣ 
Reliably communicate (advice will be gained from the patients therapy team if 
researchers are in any doubt) 
﹣ 
Read a short message 
Equipment will be loaned and previous smart-device experience isn’t needed. 
Therapists and other frontline healthcare staff involved with patients that take part will be 
invited to take part in interviews and focus groups to share their thoughts. Additionally, 
therapists will be asked to liaise with the researchers once every 1-2 weeks via phone or 
email to update researchers on the patients progress (anticipated phone call duration 5-15 
minutes). They may also be asked to provide researchers with the results of any outcome 
measures that have been completed.  
Patients carers/family members will be invited to share their thoughts.   
 
4.3 
EXCLUSION CRITERIA 
 
We are unable to recruit participants who at the time of recruitment are experiencing severe 
pain or oedema in the arm affected by their stroke. This is because their course of 
rehabilitation is different from a stroke survivor who isn’t affected by these conditions, hence 
a comparison between samples would be impossible.  
 
4.4 
WITHDRAWAL CRITERIA 
 
● Participants are free to withdraw from the study at any time. However, anonymised 
activity data collected may still be used for data analysis as this is unlinked of any 
patient identifiable information. 
● Participants will be withdrawn from the study if  
o they develop ongoing arm pain scoring 3/10 or more on the VAS or swelling 
in the affected arm during the study that is reported to be negatively impacted 
by wearing the tracker and taking part in the study.  
o Their treating therapist/medical professional in concerned about them 
participating. 
o Are not engaging with the process. 

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o They become unable to participate due to a change in their health or any 
other force majeure circumstances. 
● If at any point the researchers become concerned about a participant’s cognition or 
communication then the researchers will, in the first instance, discuss this with the 
participant’s therapist, or if this is not possible, the participant will be withdrawn from 
the study.  
 
Participants will be responsible for reporting a change in symptoms (pain, swelling, etc.) to 
researchers during the study.  
 
4.5 
DISTRESS PROTOCOL 
 
Users (patients, staff, family/carer) 
 
• In the event that a participant communicates (verbally or body language) that 
they are becoming distressed the session will be temporarily stopped and 
participant given a moment and then asked if they would like to continue.  
o If the response is that they would like the session to finish it will stop 
immediately. The researchers will ask the participant what they would 
like to do. (e.g. If they would like to be left alone, have a family/friend 
called, or stay with the researchers or in the case of staff have a 
colleague or manager contacted.)  
o If the response is that they would like the session to continue it will do 
so. However, if on a second occasion the participant becomes 
distressed the session will stop immediately. At this point the 
participant will be asked what they would like the researchers to do. 
(e.g. If they would like to be left alone, have a family/friend called, or 
stay with the researchers or in the case of staff have a colleague or 
manager contacted.) 
 
Researchers 
 
• The researchers will consider the number of patient facing sessions that they 
complete per day/week to take into consideration the exposure to potentially 
distressing information.  
• 
If the researchers at any point become distressed during a session then they 
will look to stop the interview and seek the necessary support (discussion with 
a colleague, line manager, etc.). 
 
5. ASSESSMENT AND FOLLOW-UP  
 
Participants will be involved in the study described above, their involvement lasting typically 
14 weeks. No follow up after this point is planned.  
 
 
6. 
STATISTICS AND DATA ANALYSIS 
 
Sample Size 
 
24-38 patients. 
 

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Literature advocates a sample size of 12-30 participants at the completion of a feasibility 
study. A 50% drop out rate is expected. We have taken these two points into consideration 
in addition to what is realistic within our time frame/budget to come to our current sample 
size.  
 
Data Analysis 
Analysis will be completed on the parameters and implementation of the study in addition to 
the usability of OnTrack. 
 
Data collected for the process evaluation will capture changes over time and will be a 
combination of qualitative data from interviews with stroke participants, therapists and 
frontline staff to explore their experiences of using OnTrack, as well as quantitative data on 
usage of OnTrack and the self-reported SUS. OnTrack therapy support sessions will be 
monitored through a fidelity checklist and observations. Interview data will undergo thematic 
analysis. 
 
Data will be analysed for any association between the feasibility of the intervention and 
stroke subtype, patient demographics, stroke disability, and the amount of physiotherapy 
patients receive during the intervention period. 
 
7. 
REGULATORY ISSUES 
 
7.1 
ETHICS APPROVAL 
The Chief Investigator will seek ethical approval from the NHS Research Ethics Committee 
and the Health Research Authority. The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 
18th World Medical Assembly, Helsinki 1964 and later revisions. 
7.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.   
For patients: 
Verbal consent will be provided to the therapists and then the researchers will obtain written 
consent. 
For family/carer: Written consent will be sought. 
For therapist and frontline healthcare staff: Written consent will be sought.  
The right of the participant to refuse to participate without giving reasons must be respected.  
After the participant has entered the study the clinician remains free to give alternative 
treatment to that specified in the protocol at any stage if he/she feels it is in the participant’s 
best interest, but the reasons for doing so should be recorded.  In these cases the 
participants remain within the study for the purposes of follow-up and data analysis.  All 
participants are free to withdraw at any time from the protocol treatment without giving 
reasons and without prejudicing further treatment. 
7.3 
CONFIDENTIALITY 
The Chief Investigator is responsible for preserving the confidentiality of participants taking 
part in the study.  
Researchers will have patients' names, contact numbers, emails and home addresses for 
the purposes of arranging visits. This information will be stored securely on Imperial College 
computers. 

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Participants will be assigned a participant identification number that will be used in place of 
their name wherever possible. 
The documents that links the patient's name to the ID number will be stored on a password 
protected university computer. 
Images, videos and audio recordings may be taken at any stage of the study with the 
participants consent. Media will be stored securely on a password protected device. Audio 
recordings maybe transcribed by an external service - with patient identifiable information 
removed ahead of this. Photographs taken will be anonymised as soon as possible. Videos 
will exclude participants' faces.  
Direct quotes may be used alongside a participant characteristic (e.g. Patient (M/F) had a 
stroke 6 weeks ago and could not use his arm) however participant identifiable information 
will not be used alongside quotes.  
There will be a combination of patient information stored on paper (e.g. consent forms) and 
electronically (e.g. patients address). Paper documentation will be stored in a locked 
cupboard inside a locked office at Imperial College London only accessible to the 
researchers. Electronic information will be stored on University computers that are also 
password protected.  
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study in line with Imperial College London policy.  
7.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
that apply to this study.  
7.5 
SPONSOR 
Imperial College London will act as the main Sponsor for this study.  Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
7.6 
FUNDING 
This project is funded by the Helix Centre and NIHR Imperial Biomedical Research Council 
No participant payments or incentives will be given. 
7.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition).  
 
8. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be coordinated through the Helix Centre by My 
Gianpaolo Fusari (contact details above). 
 
9. 
PUBLICATION POLICY 
 
The researchers will seek to publish their work through publications in peer-reviewed 
journals. 
 
 
 
 

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10. 
REFERENCES 
 
 
Kunkel, D., Fitton, C., Burnett, M. and Ashburn, A. (2014). Physical inactivity post-stroke: a 
3-year longitudinal study. Disability and Rehabilitation, 37(4), pp.304-310. 
 
Kwakkel, G., van Peppen, R., Wagenaar, R., Wood Dauphinee, S., Richards, C., Ashburn, 
A., Miller, K., Lincoln, N., Partridge, C., Wellwood, I. and Langhorne, P. (2004). Effects of 
Augmented Exercise Therapy Time After Stroke. Stroke, 35(11), pp.2529-2539. 
 
Laver, K., Lange, B., George, S., Deutsch, J., Saposnik, G. and Crotty, M. (2017). Virtual 
reality for stroke rehabilitation. Cochrane Database of Systematic Reviews. 
 
Loureiro, R., Harwin, W., Nagai, K. and Johnson, M. (2011). Advances in upper limb stroke 
rehabilitation: a technology push. Medical & Biological Engineering & Computing, 49(10), 
pp.1103-1118. 
 
Stroke Association (2017). State of the Nation – Stroke Statistics. London.