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On-Track Feasibility Study of a Rehabilitation System for Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944486
Recruitment Status : Completed
First Posted : May 9, 2019
Results First Posted : March 29, 2022
Last Update Posted : October 5, 2022
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: Feasibility of OnTrack Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
On-Track
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.




Primary Outcome Measures :
  1. Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews [ Time Frame: 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.

  2. Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews [ Time Frame: 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.


Secondary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 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.

  2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [ Time Frame: 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.


  3. Montreal Cognitive Assessment (MoCA) [ Time Frame: 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.

  4. Albert's Test - Unilateral Spatial Neglect (USN) [ Time Frame: 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.


  5. System Usability Scale (SUS) [ Time Frame: 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.

  6. Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions [ Time Frame: 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.


  7. Motor Assessment Log (MAL) - Questionnaire [ Time Frame: 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.

  8. Visual Analogue Scale for Pain - Question [ Time Frame: 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)

  9. Friends and Family Test [ Time Frame: 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.

  10. EQ 5D 5L (Health Related Quality of Life) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944486


Locations
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United Kingdom
Imperial Collage NHS Healthcare Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Ara Darzi, MD Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03944486    
Other Study ID Numbers: 19SM5146
First Posted: May 9, 2019    Key Record Dates
Results First Posted: March 29, 2022
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Cerebrovascular Accident
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases