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

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ClinicalTrials.gov Identifier: NCT03944486
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : August 15, 2019
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 Other: Feasibility of On-Track 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)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
On-Track
One arm feasibility study
Other: Feasibility of On-Track
Patients to use digital application- study assessed the feasibility of the application for patients and therapists.




Primary Outcome Measures :
  1. Feasibility of On-Track to patients assessed by semi structured interviews [ Time Frame: 12 months ]
    Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of On-Track


Other Outcome Measures:
  1. Feasibility of On-Track to therapists assessed by semi structured interviews [ Time Frame: 12 months ]
    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.

  2. Fugl-Meyer - a physical test of a stroke patients functional arm ability e.g. their strength and coordination. [ Time Frame: 12 months ]
    This outcome measure assesses physical function of a stroke patients arm

  3. Patient Activation and Motivation (PAM) - questionnaire 10-13 short questions [ Time Frame: 12 months ]
    PAM assesses a patient activation and motivation

  4. Motor Assessment Log (MAL) - questionnaire [ Time Frame: 12 months ]
    MAL - ask patients questions on their opinion about how much and how well they are using their stroke affected arm

  5. Visual Analogue Scale for pain - question [ Time Frame: 12 months ]
    Ask patients to rate their arm pain on a scale of 0-10

  6. Friends and Family test = a question [ Time Frame: 12 months ]
    Asks patient if they would recommend the service they have just received to friends/family

  7. EQ 5D 5L - questionnaire [ Time Frame: 12 months ]
    Asks approx. 5 short questions to patients assessing their quality of life



Information from the National Library of Medicine

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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:

  • Adult Stroke Survivor with arm impairment from the stroke.
  • Able to give informed consent and communicate reliably.
  • Able to read

Exclusion Criteria:

  • Patients with severe arm pain or swelling.

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


Contacts
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Contact: Gianpaolo Fusari 07767786778 gianpaolo@helixcentre.com

Locations
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United Kingdom
Imperial Collage NHS Healthcare Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Ara Darzi       a.darzi@nhs.net   
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Ara Darzi, MD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03944486     History of Changes
Other Study ID Numbers: 19SM5146
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
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