Trial Outcomes & Findings for On-Track Feasibility Study of a Rehabilitation System for Stroke Patients (NCT NCT03944486)

Last Updated: 2024-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Week 13

Results posted on

2024-03-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	OnTrack One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Overall Study STARTED	24
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some data was not collected before participant was withdrawn

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	On-Track n=24 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=24 Participants
Age, Categorical >=65 years	8 Participants n=24 Participants
Age, Continuous	61.133 years n=21 Participants • Some data was not collected before participant was withdrawn
Sex: Female, Male Female	12 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants
Region of Enrollment United Kingdom	24 participants n=24 Participants
Patient Activation Measure (PAM)	69.7 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
Motor Activity Log (MAL) MAL (How much)	2.0 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
Motor Activity Log (MAL) MAL (How well)	2.26 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
Montreal Cognitive Assessment (MoCA) pre-Covid 19 restrictions	22.6 units on a scale n=8 Participants • 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)
Montreal Cognitive Assessment (MoCA) post-Covid 19 restrictions	17.75 units on a scale n=4 Participants • 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)
Albert's Test	2 Participants n=12 Participants • Only measuring participants who completed the intervention.
Visual Analog Scale for Pain	0.8 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
EQ 5D 5L (Health related quality of life)	0.462 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
mRankin	2.8 units on a scale n=12 Participants • Only measuring participants who completed the intervention.
Fugl-Meyer Assessment for upper extremity (FMA-UE)	37.7 units on a scale STANDARD_DEVIATION 17.2 • n=12 Participants • Only measuring participants completing the intervention

PRIMARY outcome

Timeframe: Week 13

Population: Semi-structured interviews on participants who finished the intervention

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study 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	12 Participants

PRIMARY outcome

Timeframe: Week 13

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.

Outcome measures

Outcome measures
Measure	OnTrack n=13 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews	6 Participants

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Modified Rankin Scale Baseline	2.8 units on a scale Standard Deviation 1.1
Modified Rankin Scale Follow-up 1 (week 7)	2.5 units on a scale Standard Deviation 0.8
Modified Rankin Scale Follow-up 2 (week 13)	1.9 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	OnTrack n=7 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Baseline	37.7 units on a scale Standard Deviation 17.2
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Follow up 1 (week 7)	39 units on a scale Standard Deviation 20.1
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Follow up 2 (week 13)	36.4 units on a scale Standard Deviation 22.4

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Montreal Cognitive Assessment (MoCA) Full test cohort - Baseline	22.6 units on a scale Standard Deviation 6.9
Montreal Cognitive Assessment (MoCA) Full test cohort - Follow up 1 (week 7)	24 units on a scale Standard Deviation 5.1
Montreal Cognitive Assessment (MoCA) Full test cohort - Follow up 2 (week 13)	25.3 units on a scale Standard Deviation 1
Montreal Cognitive Assessment (MoCA) Remote test cohort - Baseline	17.8 units on a scale Standard Deviation 3.4
Montreal Cognitive Assessment (MoCA) Remote test cohort - Follow up 1 (week 7)	19 units on a scale Standard Deviation 1.9
Montreal Cognitive Assessment (MoCA) Remote test cohort - Follow up 2 (week 13)	18.3 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Unilateral Spatial Neglect (USN) (Aka Albert's Test) Baseline	2 Participants
Unilateral Spatial Neglect (USN) (Aka Albert's Test) Follow up 1 (week 7)	1 Participants
Unilateral Spatial Neglect (USN) (Aka Albert's Test) Follow up 2 (week 13)	1 Participants

SECONDARY outcome

Timeframe: Week 13

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
System Usability Scale (SUS)	84.6 score on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions Baseline	69.7 units on a scale Standard Deviation 17.8
Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions Follow up 1 (week 7)	65.8 units on a scale Standard Deviation 14.8
Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions Follow up 2 (week 13)	68.1 units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Motor Assessment Log (MAL) - Questionnaire Follow up 2 (week 13) - How Well Scale	3.17 score on a scale Standard Deviation 1.2
Motor Assessment Log (MAL) - Questionnaire Baseline - How Well Scale	2.26 score on a scale Standard Deviation 1.5
Motor Assessment Log (MAL) - Questionnaire Baseline - Amount Scale	2.00 score on a scale Standard Deviation 1.4
Motor Assessment Log (MAL) - Questionnaire Follow up 1 (week 7) - How Well Scale	3.09 score on a scale Standard Deviation 1.2
Motor Assessment Log (MAL) - Questionnaire Follow up 1 (week 7) - Amount Scale	2.94 score on a scale Standard Deviation 1.2
Motor Assessment Log (MAL) - Questionnaire Follow up 2 (week 13) - Amount Scale	3.24 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, follow-up (week 7), follow-up (week 13)

Ask patients to rate their arm pain on a scale of 0-10 (0 = no pain; 10 = unbearable pain)

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Visual Analogue Scale for Pain - Question Baseline	0.8 score on a scale Standard Deviation 1.0
Visual Analogue Scale for Pain - Question Follow up 1 (week 7)	2.5 score on a scale Standard Deviation 1.9
Visual Analogue Scale for Pain - Question Follow up 2 (week 13)	2.8 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 13

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
Friends and Family Test	4.7 score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Baseline, week 7, week 13

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.

Outcome measures

Outcome measures
Measure	OnTrack n=12 Participants One arm feasibility study Feasibility of OnTrack: Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
EQ 5D 5L (Health Related Quality of Life) Baseline	0.462 score on a scale Interval -0.186 to 0.768
EQ 5D 5L (Health Related Quality of Life) Follow-up 1 (week 7)	0.585 score on a scale Interval 0.263 to 0.837
EQ 5D 5L (Health Related Quality of Life) Follow-up 2 (week 13)	0.606 score on a scale Interval 0.375 to 0.879

Adverse Events

OnTrack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Integrity Officer

Imperial College London

Phone: +44 (0)20 7594 1872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place