Stroke Clinical Trial
Official title:
Augmented Upper Limb Physiotherapy for Acute Stroke Survivors Undergoing Inpatient Stroke Rehabilitation; a Feasibility Study
Weakness in the arm is common after stroke and can affect stroke survivors' ability to
perform some tasks. Studies show that extra sessions of arm exercise can help them to improve
their arm function and that the first 3 months is the best time to gain these benefits. A
website (www.webbasedphysio.com) has been developed and evaluated for delivering and
monitoring physiotherapy exercise programmes. This website has been modified for people after
stroke.
The purpose of this study is to assess if doing extra physiotherapy for the arm through our
web-based physio website gives any extra benefits to the usual physiotherapy received on the
ward. A total of 30 stroke survivors will be recruited from the acute stroke unit of
Hairmyres Hospital, NHS Lanarkshire, and will be randomised into two groups: intervention
(15) and control (15). The control group will receive usual care and the intervention group
will receive usual care plus an augmented and individualised 4 weeks upper limb exercise
programme delivered by the web-based physio.
The augmented programme will comprise upper limb and trunk exercises. The duration and
intensity of the programme will be based on participants' level of functional ability. For
participants with low exercise capacity, the overall time of the exercise will be less to
begin with and will build up over time to 30 minutes, five sessions per week (including
weekends), in addition to their usual physiotherapy care.
Study assessments will be at baseline, and four weeks post-intervention or just before stroke
survivors are discharged, if earlier.
At the end of the study, the feedback from physiotherapy staff, stroke survivors in the
intervention group and their carer on the augmented web-based physiotherapy will be evaluated
qualitatively and quantitatively by three questionnaires.
Study Design The study design is a randomised controlled feasibility study comparing the
effectiveness of usual care plus an augmented upper limb exercise programme delivered by a
web-based physio website versus usual care only.
Method The study will recruit from the acute stroke unit of Hairmyres Hospital, NHS
Lanarkshire.
Stroke survivors:
Physiotherapy staff in the stroke rehabilitation unit will identify 30 participants from the
stroke ward.
Potential participants will be given a participant information leaflet by a member of the
physiotherapy staff and, in addition, a participant information leaflet for their carers, if
appropriate. Potential participants will contact the Principal Investigator or the
physiotherapy staff themselves if they would like to take part in the study. If they would
like to take part in the study, the Principal Investigator will see them in the stroke
rehabilitation unit, where participants will be assessed for their eligibility to participate
in the study and they and/or their carers will have the opportunity to ask further questions.
If participants then agree to take part in the study, they will be asked to sign a consent
form.
Those who provide their informed consent will undergo baseline measures (week 0). The
following outcome measures will be used:
The Action Research Arm Test (ARAT) Trunk Impairment Scale (TIS) Mini-Mental State
Examination (MMSE) National Institutes of Health Stroke Scale (NIHSS) Modified Rankin Scale
(mRS) Modified Ashworth scale (MAS) Modified Tardieu Scale (MTS). Participants will then be
randomised to either the Intervention or Control group.
The participants in the control group will receive usual physiotherapy care only. Normally,
usual physiotherapy care is provided by physiotherapists and assistant physiotherapists, if
needed, for an average of 4 to 5 sessions per week, each lasting approximately 45 minutes.
Physiotherapists provide one to one rehabilitation session based on the Bobath technique and
the sessions are focused more on the lower limb. A leaflet about recommended upper limb
exercises is provided to stroke survivors who demonstrate an ability to perform exercises
without supervision and do not suffer from shoulder subluxation, as assessed by physiotherapy
staff.
Participants in the intervention group will undertake a progressive, individualised 4 weeks
upper limb physiotherapy intervention delivered via web-based physiotherapy in addition to
usual care. The individualised exercise programme will be provided by a physiotherapist and
will be based on clinical assessment, their goals and level of upper limb function. The
augmented programme will comprise upper limb and trunk exercises. The duration and intensity
of the programme will be based on participants' level of functional ability. For participants
with low exercise capacity, the overall time of the exercise will be less to begin with and
will build up over time to 30 minutes, five sessions per week (including weekends) in
addition to their usual physiotherapy care. All participants in this group will receive an
explanation of how to use the website, and each participant will be given individual log in
details to access his/her exercises and educational section. Physiotherapists will review and
revise the progress of each participant once a week and make any necessary changes to their
programme. Participants may contact the research team at any time during the study to ask any
questions related to the website or contact physiotherapists to request a change in their
programme. If participants have communication difficulties, where appropriate, an explanation
of how to access and use the web-based physio site will be provided to their carers who will
then support the stroke survivors to undertake their exercise programme. In addition, an
aphasia-friendly version of the website will be available to them. Participants in this group
will use their own tablets/laptop to access their programme. However, if they do not have an
internet enabled device, they will be provided with tablets and internet access for the
duration of the study.
Participants in both groups will be assessed post-intervention (week 5) with the ARAT, TIS,
MAS and MTS assessment tools. If stroke survivors in either group are discharged before the
end of the 4 week intervention period, the post-intervention assessment will take place
before their discharge. In addition, stroke survivors in the intervention group will complete
a questionnaire, providing feedback on the augmented web-based physiotherapy intervention.
The number, duration and content of all standard physiotherapy sessions will be recorded for
both groups.
Physiotherapy staff:
The study will recruit up to 5 participants from the acute stroke unit. The Principal
Investigator will identify participants from the stroke rehabilitation unit. The
physiotherapy staff will be informed of the study by the Principal Investigator. If they
would like to take part in the study, there are few things that they will be asked to do,
before, during and at the end of the study.
Before the start of the study, the Principal Investigator will attend to the stroke unit to
explain the study and demonstrate the web-based physiotherapy website
(www.webbasedphysio.com), and they will be given an opportunity to ask questions about the
study. They then will be asked to sign a consent form. After that, they will receive training
in the use of the website.
When the study starts, the physiotherapists will be asked to do the following:
- Approach potential participants (stroke survivors and carers) from the stroke ward by
contacting the researcher and distributing the participant information sheets.
- Assess the stroke survivors who have been allocated to the intervention group and set up
an individualised arm exercise programme for each participant. The rehabilitation
programme needs to build up in a gradual manner to reach a point where the stroke
survivors are able to perform these exercises for 30 minutes each session, 5 times a
week, in addition to the physiotherapy care that they receive while on the ward.
- Review the stroke survivor participants' rehabilitation programmes once a week and
revise as appropriate.
- Respond, as appropriate, to any requests from participants to change to their programme.
At the end of the study, the Principal Investigator will ask them to complete a short
questionnaire related to their experience of monitoring the stroke survivor in the use of the
web-based physiotherapy website.
Carers:
The study will recruit up to 15 participants from the acute stroke unit. The physiotherapy
staff in the stroke rehabilitation unit will identify participants from the stroke ward.
Potential participants will be given a participant information leaflet by a member of the
physiotherapy staff. Potential participants will contact the Principal Investigator or the
physiotherapy staff themselves if they would like to take part in the study. If they would
like to take part in the study, the Principal Investigator will see them in the stroke
rehabilitation unit, where participants will be assessed for their eligibility to participate
in the study and they will have the opportunity to ask further questions. If participants
then agree to take part in the study, they will be asked to sign a consent form.
The physiotherapists will give them an explanation of how to access and use the website to
support the stroke survivor participants.
At the end of the study, the Principal Investigator will ask them to complete a short
questionnaire related to their experience of supporting the stroke survivor participants in
doing their exercises through the web-based physiotherapy website.
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