On-Track Feasibility Study of a Rehabilitation System for Stroke Patients
- Conditions
- Cerebrovascular Accident
- Interventions
- Device: Feasibility of OnTrack
- Registration Number
- NCT03944486
- Lead Sponsor
- Imperial College London
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description On-Track Feasibility of OnTrack 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.
- Primary Outcome Measures
Name Time Method Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews 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.
Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews Week 13 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.
- Secondary Outcome Measures
Name Time Method Motor Assessment Log (MAL) - Questionnaire 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.
Friends and Family Test 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.
System Usability Scale (SUS) 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.
Visual Analogue Scale for Pain - Question 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)
EQ 5D 5L (Health Related Quality of Life) 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.
Modified Rankin Scale 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.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Baseline, follow-up (week 7), follow-up (week 13) 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.Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions 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.Montreal Cognitive Assessment (MoCA) 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.
Unilateral Spatial Neglect (USN) (Aka Albert's Test) 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.
Trial Locations
- Locations (1)
Imperial Collage NHS Healthcare Trust
🇬🇧London, United Kingdom