NCT03260686

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

August 18, 2017

Last Update Submit

August 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor status score (MSS)

    Measures shoulder, elbow wrist hand and finger movements.

    4 weeks

Secondary Outcomes (3)

  • Leeds Movement performance Index

    4 weeks

  • Time

    4 weeks

  • Generalised self efficacy score (GSE)

    4 weeks

Study Arms (2)

Video Guided Group

EXPERIMENTAL

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.

Other: experimental

Treatment as usual

NO INTERVENTION

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

Interventions

video guide for upper limb exercise

Video Guided Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Carl Thompson

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 24, 2017

Study Start

November 28, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

August 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share