Back to resultsOn-Track Feasibility Study of a Rehabilitation System for Stroke Patients
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Feasibility of OnTrack
Sponsored by
About this trial
This is an interventional device feasibility trial for Cerebrovascular Accident focused on measuring Cerebrovascular Accident
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.
Sites / Locations
- Imperial Collage NHS Healthcare Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
On-Track
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Albert's Test - Unilateral Spatial Neglect (USN)
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.
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.
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.
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.
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)
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.
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.
Full Information
NCT ID
NCT03944486
First Posted
April 29, 2019
Last Updated
September 28, 2022
Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03944486
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Cerebrovascular Accident
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
On-Track
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Feasibility of OnTrack
Intervention Description
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Primary Outcome Measure Information:
Title
Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
Description
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
Title
Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
Description
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
Secondary Outcome Measure Information:
Title
Modified Rankin Scale
Description
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)
Title
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Description
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)
Title
Montreal Cognitive Assessment (MoCA)
Description
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)
Title
Albert's Test - Unilateral Spatial Neglect (USN)
Description
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)
Title
System Usability Scale (SUS)
Description
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
Title
Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions
Description
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)
Title
Motor Assessment Log (MAL) - Questionnaire
Description
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)
Title
Visual Analogue Scale for Pain - Question
Description
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)
Title
Friends and Family Test
Description
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
Title
EQ 5D 5L (Health Related Quality of Life)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ara Darzi, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial Collage NHS Healthcare Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36171046
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.
Results Reference
derived
PubMed Identifier
32205375
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.
Results Reference
derived
Learn more about this trial
On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
We'll reach out to this number within 24 hrs