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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Track | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility of OnTrack | Device | Patients to use digital application- study assessed the feasibility of the application for patients and therapists. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, follow-up (week 7), follow-up (week 13) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ara Darzi, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Collage NHS Healthcare Trust | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37597873 | Derived | 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. | |
| 36171046 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | OnTrack | One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | On-Track | One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Semi-structured interviews on participants who finished the intervention | Posted | Count of Participants | Participants | Week 13 |
|
20 months
Participants in the trial were at zero risk for all-cause mortality and serious adverse events stemming from using the intervention or participating in the trail
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OnTrack | One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Integrity Officer | Imperial College London | +44 (0)20 7594 1872 | e.magnusson@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Sep 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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) | 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. | 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. | Baseline, week 7, week 13 |
| 32205375 | Derived | 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. |
| Participants |
|
| Age, Continuous | Some data was not collected before participant was withdrawn | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Activation Measure (PAM) | 10-item survey assessing underlying knowledge, skills and confidence integral to managing own health and healthcare. PAM segments individuals 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. | Only measuring participants who completed the intervention. | Mean | Full Range | units on a scale |
|
| Motor Activity Log (MAL) | 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. | Only measuring participants who completed the intervention. | Mean | Full Range | units on a scale |
|
| Montreal Cognitive Assessment (MoCA) | Aims to test subjects with Mild Cognitive Impairment irrespective of etiology. Covers most cognitive domains and is available in 3 versions to decrease possible learning effects when the MoCA is administered every 3 months or less. Scores on the MoCA range from 0 to 30, with a score of 26 and higher generally considered normal. | Only measuring participants who completed the intervention. Measure is divided in two groups - 1) participants recruited pre-Covid 19 pandemic restrictions (maximum score of 30), and 2) Participants recruited after Covid 19 restrictions (maximum score of 22) | Mean | Full Range | units on a scale |
|
| 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, patients must cross out lines that are placed in random orientations on a piece of paper. USN is indicated when lines are left uncrossed on the same side of the page as the patients motor deficit or brain lesion is located. Results are based on the number of lines left uncrossed on each side of the test sheet. If any lines are left uncrossed, and more than 70% of uncrossed lines are on the same side as motor deficit, USN is indicated. | Only measuring participants who completed the intervention. | Count of Participants | Participants |
|
| Visual Analog Scale for Pain | Ask patients to rate their arm pain on a scale of 0-10 (0 = no pain; 10 = unbearable pain) | Only measuring participants who completed the intervention. | Mean | Full Range | units on a scale |
|
| 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. | Only measuring participants who completed the intervention. | Mean | Full Range | units on a scale |
|
| mRankin | Modified Rankin Scale for Neurologic Disability (mRankin) measures degree of disability in daily activities of people who have suffered a stroke. Scale ranges from 0-6, where 0=no symptoms at all; 1= No significant disability despite symptoms; 2=Slight disability; unable to do all previous activities, but able to look after own affairs unassisted; 3=Moderate disability; requiring some help, but able to walk unassisted; 4=Moderately severe disability; unable to walk and attend to bodily needs unassisted; 5=Severe disability; bedridden, incontinent and requiring constant nursing care; 6=Dead | Only measuring participants who completed the intervention. | Mean | Full Range | units on a scale |
|
| 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. | Only measuring participants completing the intervention | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Week 13 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Collection of this outcome measure was suspended after the study went to a fully remote delivery method due to the outbreak of the Covid 19 pandemic. This outcome measure is not possible to administer remotely. | Posted | Mean | Standard Deviation | units on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 13 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | Baseline, follow-up (week 7), follow-up (week 13) |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Week 13 |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Baseline, week 7, week 13 |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Remote test cohort - Baseline |
|
| Remote test cohort - Follow up 1 (week 7) |
|
| Remote test cohort - Follow up 2 (week 13) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Follow up 1 (week 7) - Amount Scale |
|
| Follow up 2 (week 13) - How Well Scale |
|
| Follow up 2 (week 13) - Amount Scale |
|
|
| Title | Measurements |
|---|---|
|