An interventional study of Feasibility of OnTrack in Cerebrovascular Accident, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Imperial College London · Not applicable, Interventional, and Device feasibility
Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.
Population - stroke patients over 18 years old.
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
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Device: Feasibility of OnTrack
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of OnTrack. Interviews determine whether participants found the intervention easy to use and acceptable and if it is fit for their rehabilitation needs.
Time frame: Week 13
Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
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.
Time frame: Week 13
Modified Rankin Scale
The modified Rankin Scale is the most prevalent functional outcome measure in contemporary stroke trials. The mRS quantifies disability using an ordinal hierarchical grading from 0 (no symptoms) to 5 (severe disability). A lower number indicates lower disability.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The Fugl-Meyer Assessment for upper extremity (FMA-UE) has been tested extensively, and is found to have excellent psychometric properties. It is considered to assess the body function according to the International Classification of Functioning, Disability and Health (ICF). The FMA-UE is scored on a scale 0 - 66 points (a higher score indicates lower arm impairment) and is recommended as core measures to be used in every stroke recovery and rehabilitation trial.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Montreal Cognitive Assessment (MoCA)
The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment. The MoCA uses a 0-30 score scale and defines impairment as follows: score of 18-25=mild, 10-17=moderate and \<10 = severe. A version of the test that can be applied remotely was used after the study went fully remote due to the Coronavirus pandemic; the remote version uses a 0-22 score and impairment as follows: 13-18=mild, 7-12=moderate, and \<7 severe.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Unilateral Spatial Neglect (USN) (Aka Albert's Test)
Albert's Test is a screening tool used to detect the presence of unilateral spatial neglect (USN) in patients with stroke. In this test, a series of 40 black lines, each about 2 cm long, are randomly oriented on a sheet of white A4 size paper in 6 rows. The test sheet is presented to the patient at their midline. The examiner asks the patient to cross out all of the lines, and demonstrates what is required by crossing out the 5 central lines. The patient is encouraged to cross out all the lines until satisfied that they have all been crossed. If any lines are left uncrossed, and more than 70% of uncrossed lines are on the same side as motor deficit, USN is indicated.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
System Usability Scale (SUS)
The test is a simple, 10-item scale covering a variety of aspects of system usability, such as the need for support, training and complexity, and thus have a high level of face validity for measuring the usability of a system. The scale is from 0-100, a higher number signifies better usability.
Time frame: Week 13
Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions
The Patient Activation Measure (PAM) is a 10-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale (0 min - 100 max, a higher score indicates a higher level of activation). Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Motor Assessment Log (MAL) - Questionnaire
Structured interview intended to examine How Much and How Well the subject uses their more-affected arm outside of the laboratory setting. Standardized questions are asked about the amount of use of their more-affected arm (Amount Scale or AS) and the quality of their movement (How Well Scale or HW) during the functional activities. Two scales are printed on sheets of paper and are placed in front of the participant during test administration. Both scales range between 0 and 5 (half scores are possible, i.e. 0.5,1.5,2.5,3.5,4.5). Higher values represent a better outcome.
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Visual Analogue Scale for Pain - Question
Ask patients to rate their arm pain on a scale of 0-10 (0 = no pain; 10 = unbearable pain)
Time frame: Baseline, follow-up (week 7), follow-up (week 13)
Friends and Family Test
Asks patient if they would recommend the service they have just received to friends/family. The NHS Friends and Family Test (FFT) was created to help service providers and commissioners understand whether patients are happy with the service provided, or where improvements are needed. 5 point Likert scale questionnaire ranging from 1-5: 1 "extremely unlikely", 2 "unlikely", 3 "neither likely nor unlikely", 4 "likely", 5 "extremely likely", an "I don't know" option is also provided. Higher values represent better outcomes.
Time frame: Week 13
EQ 5D 5L (Health Related Quality of Life)
Descriptive system using 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 possible values: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems, and 5 extreme problems. Patient is asked to assign a value to each dimension. The digits for the 5 dimensions are combined into a 5-digit number describing the patient's health state. An index value is derived from the health state ranging from -0.285 (value of 5 on all dimensions) to 1 (value of 1 on all dimensions). Higher index values indicate better outcomes.
Time frame: Baseline, week 7, week 13
Recruitment period: August 2019 - December 2020 Participants were identified and screened by therapists at an acute setting. Recruitment followed with participants beginning their participation at the acute setting and followed up in the community. After the start of the Covid-19 pandemic, participants were identified in the acute setting but only started participation once discharged to the community.
| Milestone | OnTrack |
|---|---|
| Started | 24 |
| Completed | 12 |
| Not completed | 12 |
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of OnTrack. Interviews determine whether participants found the intervention easy to use and acceptable and if it is fit for their rehabilitation needs.
| Participants | OnTrack |
|---|---|
| Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews | 12 |
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.
| Participants | Recruiting Therapists |
|---|---|
| Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews | 6 |
The modified Rankin Scale is the most prevalent functional outcome measure in contemporary stroke trials. The mRS quantifies disability using an ordinal hierarchical grading from 0 (no symptoms) to 5 (severe disability). A lower number indicates lower disability.
| units on a scale | On-Track |
|---|---|
| Baseline | 2.8 ± 1.1 |
| Follow-up 1 (week 7) | 2.5 ± 0.8 |
| Follow-up 2 (week 13) | 1.9 ± 0.9 |
The Fugl-Meyer Assessment for upper extremity (FMA-UE) has been tested extensively, and is found to have excellent psychometric properties. It is considered to assess the body function according to the International Classification of Functioning, Disability and Health (ICF). The FMA-UE is scored on a scale 0 - 66 points (a higher score indicates lower arm impairment) and is recommended as core measures to be used in every stroke recovery and rehabilitation trial.
| units on a scale | On-Track |
|---|---|
| Baseline | 37.7 ± 17.2 |
| Follow up 1 (week 7) | 39 ± 20.1 |
| Follow up 2 (week 13) | 36.4 ± 22.4 |
The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment. The MoCA uses a 0-30 score scale and defines impairment as follows: score of 18-25=mild, 10-17=moderate and \<10 = severe. A version of the test that can be applied remotely was used after the study went fully remote due to the Coronavirus pandemic; the remote version uses a 0-22 score and impairment as follows: 13-18=mild, 7-12=moderate, and \<7 severe.
| units on a scale | On-Track |
|---|---|
| Full test cohort - Baseline | 22.6 ± 6.9 |
| Full test cohort - Follow up 1 (week 7) | 24 ± 5.1 |
| Full test cohort - Follow up 2 (week 13) | 25.3 ± 1 |
| Remote test cohort - Baseline | 17.8 ± 3.4 |
| Remote test cohort - Follow up 1 (week 7) | 19 ± 1.9 |
| Remote test cohort - Follow up 2 (week 13) | 18.3 ± 2.4 |
Albert's Test is a screening tool used to detect the presence of unilateral spatial neglect (USN) in patients with stroke. In this test, a series of 40 black lines, each about 2 cm long, are randomly oriented on a sheet of white A4 size paper in 6 rows. The test sheet is presented to the patient at their midline. The examiner asks the patient to cross out all of the lines, and demonstrates what is required by crossing out the 5 central lines. The patient is encouraged to cross out all the lines until satisfied that they have all been crossed. If any lines are left uncrossed, and more than 70% of uncrossed lines are on the same side as motor deficit, USN is indicated.
| Participants | On-Track |
|---|---|
| Baseline | 2 |
| Follow up 1 (week 7) | 1 |
| Follow up 2 (week 13) | 1 |
The test is a simple, 10-item scale covering a variety of aspects of system usability, such as the need for support, training and complexity, and thus have a high level of face validity for measuring the usability of a system. The scale is from 0-100, a higher number signifies better usability.
| score on a scale | On-Track |
|---|---|
| System Usability Scale (SUS) | 84.6 ± 13.1 |
The Patient Activation Measure (PAM) is a 10-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale (0 min - 100 max, a higher score indicates a higher level of activation). Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
| units on a scale | OnTrack |
|---|---|
| Baseline | 69.7 ± 17.8 |
| Follow up 1 (week 7) | 65.8 ± 14.8 |
| Follow up 2 (week 13) | 68.1 ± 10.3 |
Structured interview intended to examine How Much and How Well the subject uses their more-affected arm outside of the laboratory setting. Standardized questions are asked about the amount of use of their more-affected arm (Amount Scale or AS) and the quality of their movement (How Well Scale or HW) during the functional activities. Two scales are printed on sheets of paper and are placed in front of the participant during test administration. Both scales range between 0 and 5 (half scores are possible, i.e. 0.5,1.5,2.5,3.5,4.5). Higher values represent a better outcome.
| score on a scale | OnTrack |
|---|---|
| Baseline - How Well Scale | 2.26 ± 1.5 |
| Baseline - Amount Scale | 2.00 ± 1.4 |
| Follow up 1 (week 7) - How Well Scale | 3.09 ± 1.2 |
| Follow up 1 (week 7) - Amount Scale | 2.94 ± 1.2 |
| Follow up 2 (week 13) - How Well Scale | 3.17 ± 1.2 |
| Follow up 2 (week 13) - Amount Scale | 3.24 ± 1.3 |
Ask patients to rate their arm pain on a scale of 0-10 (0 = no pain; 10 = unbearable pain)
| score on a scale | OnTrack |
|---|---|
| Baseline | 0.8 ± 1.0 |
| Follow up 1 (week 7) | 2.5 ± 1.9 |
| Follow up 2 (week 13) | 2.8 ± 2.3 |
Asks patient if they would recommend the service they have just received to friends/family. The NHS Friends and Family Test (FFT) was created to help service providers and commissioners understand whether patients are happy with the service provided, or where improvements are needed. 5 point Likert scale questionnaire ranging from 1-5: 1 "extremely unlikely", 2 "unlikely", 3 "neither likely nor unlikely", 4 "likely", 5 "extremely likely", an "I don't know" option is also provided. Higher values represent better outcomes.
| score on a scale | OnTrack |
|---|---|
| Friends and Family Test | 4.7 (4 to 5) |
Descriptive system using 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 possible values: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems, and 5 extreme problems. Patient is asked to assign a value to each dimension. The digits for the 5 dimensions are combined into a 5-digit number describing the patient's health state. An index value is derived from the health state ranging from -0.285 (value of 5 on all dimensions) to 1 (value of 1 on all dimensions). Higher index values indicate better outcomes.
| score on a scale | OnTrack |
|---|---|
| Baseline | 0.462 (-0.186 to 0.768) |
| Follow-up 1 (week 7) | 0.585 (0.263 to 0.837) |
| Follow-up 2 (week 13) | 0.606 (0.375 to 0.879) |
Collected over 20 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OnTrack | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | On-Track |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 8 |
| Age, Continuous(years) | On-Track |
|---|---|
| Mean | 61.133 (33.5 to 82.5) |
| Sex: Female, Male(Participants) | On-Track |
|---|---|
| Female | 12 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | On-Track |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | On-Track |
|---|---|
| United Kingdom | 24 |
| Patient Activation Measure (PAM)(units on a scale) | On-Track |
|---|---|
| Mean | 69.7 (42.9 to 100) |
| Motor Activity Log (MAL)(units on a scale) | On-Track |
|---|---|
| MAL (How much) | 2.0 (0.39 to 4.18) |
| MAL (How well) | 2.26 (0.38 to 4.75) |
| Montreal Cognitive Assessment (MoCA)(units on a scale) | On-Track |
|---|---|
| pre-Covid 19 restrictions | 22.6 (10 to 27) |
| post-Covid 19 restrictions | 17.75 (13 to 21) |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Imperial College London