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Video Guided Exercise After Stroke

Primary Purpose

Cerebral Stroke ,Cerebrovascular Accident, Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
experimental
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke ,Cerebrovascular Accident, Stroke

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Adults aged 18 or over with capacity to give informed consent (according to the mental capacity act 2005) Clinically diagnosed with a first time stroke (To reduce the impact of previous training and rehabilitation interventions) (Stroke physician, from medical notes) Hospitalised patient, staying on a stroke rehabilitation ward. Moderate or mild unilateral upper limb paresis, with minimal inattention.(Therapist assessment)(Mild MSS15-29, Moderate MSS scale ≥30 ) Medically stable and physically capable of participating in active rehabilitation (Ward Doctor) Able to understand consent process and communicate such i.e. minimal aphasic symptoms, able to understand English language enough to consent. (Ward therapists with advice from speech and language therapist where appropriate) No previous significant upper limb pathology that may impact on the participants ability to complete activities Discussion with patient and medical notes review) No Hemi-paretic shoulder pain. (Therapist assessment) Signed informed consent to participate in the trial Active rehabilitation goals, and deemed fit and appropriate for rehabilitation by the therapy team.

Exclusion Criteria:

- Second or more stroke (Stroke physician, from medical notes) Likely to be discharged within two weeks of commencement of trial (It is not always apparent how long someone will remain an in-patient and depends not only on disability, but also social circumstances and patient wishes- therapists judgement for this.(MDT assessment) Age below 18 years Unable to give informed consent. Psychiatric or depressive symptoms that may affect the participants ability to consent or complete the intervention activities(ward Dr) Participation in another clinical trial. Significant apraxia making independent exercise practice difficult (Occupational therapist /physiotherapist judgement) Visual impairment impacting on ability to observe video (Ward team)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Video Guided Group

    Treatment as usual

    Arm Description

    Participants receive standard care physiotherapy for their upper limb rehabilitation, with exercises given either verbally or in writing as decided by the prescribing clinician. In addition the participants will receive a personalised video guide of their exercises, filmed during their therapy session to use for independent practice when back on the ward.

    Participants receive standard care physiotherapy for their upper limb rehabilitation, with exercises given either verbally or in writing as decided by the prescribing clinician

    Outcomes

    Primary Outcome Measures

    Motor status score (MSS)
    Measures shoulder, elbow wrist hand and finger movements.

    Secondary Outcome Measures

    Leeds Movement performance Index
    Measures quality of movement
    Time
    Time spent exercising out of therapy
    Generalised self efficacy score (GSE)
    Measures self - efficacy

    Full Information

    First Posted
    August 18, 2017
    Last Updated
    August 18, 2017
    Sponsor
    University of Leeds
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03260686
    Brief Title
    Video Guided Exercise After Stroke
    Official Title
    The Effectiveness of Video Guided Exercise After Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 28, 2016 (Actual)
    Primary Completion Date
    April 30, 2017 (Actual)
    Study Completion Date
    April 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leeds

    4. Oversight

    5. Study Description

    Brief Summary
    People who have had a stroke benefit from opportunities to practice the activities they need to re-learn. It is common practice to give patients written exercises to guide their practice out of therapy session. Whilst more practice is better, it is important that the activities are practiced accurately, to ensure that the right movement patterns are re-learned. The aim of this study, is to evaluate whether an intervention providing in-patients who have had a stroke an opportunity to use a simple video guide to help them perform their exercises accurately would improve clinical outcomes. Watching an activity being performed helps you to learn the activity more effectively. The focus of this study is arm rehabilitation. The participants will be adult in-patients in Leeds Teaching Hospitals Trust, and will have had a first time stroke that has left them with some arm weakness. The participants will be matched according to the severity of their weakness, then randomly allocated to either a treatment as usual group, or an intervention group. Those in the intervention group will have their exercises for their arm and hand recorded onto a tablet during their normal therapy session. They will then be lent the tablet for the duration of the trial, so they can have a visual guide to help them throughout the trial period. Ward staff will be shown how to use the tablet to help any participants who struggle with the technology. Measurements will be made before and after the trial period to look at ability to move the arm and hand, quality of movement, self-efficacy and time spent exercising. Participants and staff will be asked for their experiences of the intervention or normal practice. This is a feasibility study with an embedded process evaluation.
    Detailed Description
    This is a small single blind RCT. The outcome assessor will be blinded to the participants status as either in the treatment as usual group or the intervention group. As a feasibility study conducted as part of the development, and planned larger evaluation, of a complex intervention we have drawn heavily on the MRC guidance on complex interventions and process evaluation. All participants will have the capacity to make an informed decision to consent. The participants who are suitable to be included in the study will be consented by the student researcher (with support from the Speech and language therapist if needed). This will be done in accordance with the process described in section A27-1. To reduce the possibility of patients who have severe impairment or other excluding factors being approached an initial screening will have occurred by the direct clinical care team of the potential participants medical notes. This occurs as part of their normal initial assessment of the patient. Eight patients with mild upper limb impairment will be recruited and eight with moderate upper limb impairment. (Three of each category for both treatment as usual and intervention group). A tally will be kept of those with mild and moderate weakness in their upper limb, and recruitment will cease once eight participants of each category have been consented. The trial period will commence as a rolling start, with each person starting the trial period as soon as their 'matched pair' has been recruited. Each of the matched pair will be randomly allocated into either control or intervention group. Once the participants have been consented, they will undergo their baseline assessments. This will be carried out by an experienced neurological physiotherapist from another ward (Blinded to the randomisation into the control or intervention group). The assessment session will be carried out in one of the ward rehabilitation rooms, and is predicted to take no more than half an hour, though more time will be allowed should the participant have further questions. The patients in the control group will then have their therapy programme as normal for the next four weeks, or until discharge, whichever comes sooner. The patients in the intervention group will have their next therapy session in the normal manner, but during or at the end of the session,(whichever is most appropriate) the exercises prescribed by the therapist will be filmed onto a tablet. It will consist of the therapist performing the exercise three times to allow the participant to get the idea of the correct movement, and then the participant performing the action three times with the therapist giving verbal prompts to correct the movement.For the intervention group the therapist will be asked to film any upper limb exercises prescribed onto an i-pad, which will provided (one for each patient). Filming will be from two to three feet away, and from whatever angle the physiotherapist feels is most appropriate. The video need not include all of the patient or physiotherapist demonstrator, but should include as much of their body as the therapist feels is needed for guidance. The i-pad can then be taken by the patient to be used by their bedside. Participants will be given a prompt sheet for playing back their exercises, and the I-pad interface will have been developed with The University of Leeds School of Medicine technology department to make it as intuitive as possible. For both patient groups, if the therapist would normally provide a written exercise sheet this will also be provided. The exercises prescribed will be updated by the therapist as deemed appropriate according to the participants needs, either by re-recording them in a subsequent session, and/or updating written exercise sheets. The participants in the intervention group will have access to the tablet they are using for the duration of the study, labelled and kept in their private bedside locker. Ward staff will be prompted to ensure that during the day if a patient wishes to do their exercises they are 'set up' to do so, either by ensuring exercise sheets are to hand, or the tablet is within reach, and if necessary switched on and opened, with prompts how to start the video (as the technology may be unfamiliar to the patients.) Ward staff will also ensure the tablets are regularly charged. At the end of the four week period, or up to 72 hours before discharge, the baseline assessment barrage will be repeated by the baseline assessor (still blinded, participants prompted not to divulge group allocation) In order to evaluate the experience of exercising out of therapy sessions, the research physiotherapist will conduct a one to one interview with some of the patient participants. They will be selected via purposive sampling, accounting for initial weakness category and previous experience of using tablet technology. Open ended questions will be used to find out how easy they found it to exercise their affected arm out of therapy time. Questions asked will be: What factors made it difficult to exercise out of therapy time? How did you cope using the tablet? (intervention group only) Did the video guide influence how you performed the exercises?(intervention group only) What suggestions do you have to make using the tablet or video guide better? Therapy staff will be asked in a focus group setting: How useful do you think the video guide was in helping your patients carry out practice out of therapy sessions? How did filming the exercises impact on their normal therapy sessions? Do they think this intervention could work in practice? What would need to change to make it work? Interviews with patient participants will be carried out in the treatment rooms or by the patients bed if this is their preference. The Physiotherapy team focus group will be carried out in one of the available treatment rooms. Patient participants will be asked if they wish to have feedback on the study, and if so home or discharge destination contact details will be recorded, and kept securely, so the participants can receive a written summary of the outcome after the student write up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Stroke ,Cerebrovascular Accident, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Video Guided Group
    Arm Type
    Experimental
    Arm Description
    Participants receive standard care physiotherapy for their upper limb rehabilitation, with exercises given either verbally or in writing as decided by the prescribing clinician. In addition the participants will receive a personalised video guide of their exercises, filmed during their therapy session to use for independent practice when back on the ward.
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Participants receive standard care physiotherapy for their upper limb rehabilitation, with exercises given either verbally or in writing as decided by the prescribing clinician
    Intervention Type
    Other
    Intervention Name(s)
    experimental
    Intervention Description
    video guide for upper limb exercise
    Primary Outcome Measure Information:
    Title
    Motor status score (MSS)
    Description
    Measures shoulder, elbow wrist hand and finger movements.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Leeds Movement performance Index
    Description
    Measures quality of movement
    Time Frame
    4 weeks
    Title
    Time
    Description
    Time spent exercising out of therapy
    Time Frame
    4 weeks
    Title
    Generalised self efficacy score (GSE)
    Description
    Measures self - efficacy
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Adults aged 18 or over with capacity to give informed consent (according to the mental capacity act 2005) Clinically diagnosed with a first time stroke (To reduce the impact of previous training and rehabilitation interventions) (Stroke physician, from medical notes) Hospitalised patient, staying on a stroke rehabilitation ward. Moderate or mild unilateral upper limb paresis, with minimal inattention.(Therapist assessment)(Mild MSS15-29, Moderate MSS scale ≥30 ) Medically stable and physically capable of participating in active rehabilitation (Ward Doctor) Able to understand consent process and communicate such i.e. minimal aphasic symptoms, able to understand English language enough to consent. (Ward therapists with advice from speech and language therapist where appropriate) No previous significant upper limb pathology that may impact on the participants ability to complete activities Discussion with patient and medical notes review) No Hemi-paretic shoulder pain. (Therapist assessment) Signed informed consent to participate in the trial Active rehabilitation goals, and deemed fit and appropriate for rehabilitation by the therapy team. Exclusion Criteria: - Second or more stroke (Stroke physician, from medical notes) Likely to be discharged within two weeks of commencement of trial (It is not always apparent how long someone will remain an in-patient and depends not only on disability, but also social circumstances and patient wishes- therapists judgement for this.(MDT assessment) Age below 18 years Unable to give informed consent. Psychiatric or depressive symptoms that may affect the participants ability to consent or complete the intervention activities(ward Dr) Participation in another clinical trial. Significant apraxia making independent exercise practice difficult (Occupational therapist /physiotherapist judgement) Visual impairment impacting on ability to observe video (Ward team)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Video Guided Exercise After Stroke

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