A single-blind randomized controlled trial will be conducted on two rehabilitation wards of a secondary referral hospital. Participants will be randomly assigned into the JRS WAVE intervention that will last for the duration of the stay on the ward, with a minimum dose of 8 days and maximum of 40 or usual care. All participants will provide written informed consent, and ethical clearance has been received.
Participants
Inclusion
Eligible participants will be adults admitted to the two rehabilitation wards at the Launceston General Hospital with reduced mobility after haemorrhagic or infarct cerebrovascular accident of recent onset (less than 6 months) with a clinician-assessed capacity for improvement in mobility.
Exclusion criteria will be the following: a marked cognitive impairment so that instructions are not able to be carried out (determined by the therapist); insufficient English language skills to participate in rehabilitation and no available interpreter; a medical condition precluding exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm or a weight-bearing restriction); or severe receptive or expressive dysphasia of severe visual impairment.
Sample size and justification
Sample size calculation was based on previously reported clinical trial data and based on the outcome measure of functional reach, that provided baseline mean (standard deviation) data of 25.6 (7.4) cm [14]. Researchers determined that a clinically relevant difference of 3.7 cm would require a sample size of 63 (P <0.05, power 80 %). Seventy-four participants will be recruited to allow for a 15 % dropout rate. The proposed size of this study is comparable to more recently published trial data, which suggest that a clinical difference of 3 cm would require 78 participants [3].
Recruitment
All patients admitted to the two rehabilitation wards during the trial period will be screened for inclusion by a senior neurological physiotherapist. Eligible patients will be given information about the project and if they are interested, a research assistant (physiotherapist) will be contacted to provide further information. Written consent will be obtained before participation in the project. Demographic and background information will be collected. Ethical approval for this study has been received from the Human Research Ethics Committee (Tasmania) Network (approval number H0013769).
Study design
All participants will undergo two measurement sessions by a physiotherapist blinded to group allocation: one on entry into the study (pre-test) and one after the 8-week period (post-test) or prior to discharge if discharged before 8 weeks. All pre-test measures will be completed prior to randomization.
Randomization
Allocation into intervention or control group will be performed by using a computer-generated random number schedule with variable block sizes 2–6. Generation of the randomization sequence will be generated by a researcher not involved in recruitment or assessment. Group allocation will be concealed by using consecutively numbered opaque sealed envelopes, opened in the presence of the participant after completion of assessment.
Intervention and usual care
Participants in both groups will be assessed by a physiotherapist who will deliver individualised targeted therapy to meet their specific needs.
Usual care
In addition to receiving individualised therapy, the usual care group will have a therapist prescribe a series of repetitive exercises (e.g., practice of arm activities, standing up or stepping) in a group setting with physiotherapists or physiotherapy assistants. Usual care varies between the two wards used in this trial. Specific information about usual care for each ward and the delivery plan is provided in Appendix 1.
Intervention group
JRS WAVE technology use will replace group exercise prescribed in the usual care group or allied health assistant sessions which are usual care on ward two. Participants randomly assigned to the intervention group of this trial will receive individualised prescription of appropriate technology-based exercises to enhance physical activity and mobility. In addition to receiving individualised targeted therapy, each participant will be asked to use the intervention technologies for up to 1 hour each day. As such, both groups will be matched for time in rehabilitation to determine the impact of the technology-based intervention compared with group exercise.
Therapy staff will teach participants to use the equipment and develop individualised exercise programs to enable participants to use the equipment safely. To minimise the risk of contamination, use of the technologies will be done out of sight of control group participants where possible.
Quality control and feasibility
Feasibility will be monitored by recording numbers of potential participants who are recruited into the study, the number of sessions undertaken out of the possible number of sessions available during the inpatient stay, and reasons for missed sessions.
Assessment of post-study outcome measures will be performed by a neurological physiotherapist who is not involved in the provision of therapy to that client. This will ensure blinding of assessment and maintain the quality of this project. It is not possible to blind the participant as to the group allocation.
Efficacy
Physical activity
All participants will have their activity monitored for 1 week during the trial by using an accelerometer (ActivPal; PAL Technologies, Glasgow, UK). These devices have been validated in older people with impaired function [18]. Data will be analysed in each group to determine the amount of time spent in activities of low, moderate and high energy expenditure. Energy expenditure during rehabilitation will also be compared between groups.
Upper-limb function
Upper-limb function will be measured by using the Upper Arm Function component of the Modified Motor Assessment Scale. This test uses a six-point scale to measure a progression of proximal arm strength and has been shown to be reliable in this population [12]. The box and block test will also be used to provide quantitative results [8].
Sitting balance
Sitting balance will be measured by using the standardised sitting balance test, which uses a four-point rating scale to measure sitting balance from poor to normal. It correlates significantly with other measures of function [17].
Standing balance
Standing balance in the anterior-posterior direction will be measured by using the Functional Reach test [9], and balance control in the medio-lateral by using the Lateral Reach test [4]. Functional Reach measures dynamic balance control during a self-generated perturbation anteriorly. Participants will stand next to a wall and use their less-affected arm to measure reach distance. Lateral reach measures side-to-side reach ability and will be measured with the participant in an upright position and reaching to the side. The shoulder landmark will be used for each side to ensure that shoulder range does not limit the test. This test can be performed in a seated position if the therapist deems this necessary for safety.
Dynamic balance
Dynamic balance will be assessed by using the step test, which involves tapping the foot on and off a step within a 15-second time frame and recording the number of repetitions [11].
Mobility
Mobility will be measured by using a 10-meter walk test. Participants will be asked to walk 10 meters using their usual gait aid, and measurements of time taken, stride length, cadence and rate will be recorded [7]. Functional mobility will also be recorded by using the “timed up and go” test [15].
Safety
Adverse events during both intervention care and usual care will be recorded. Also, after each session, participants will provide the following data of their experience participating in the group or using the technology:
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Borg rating of perceived exertion scale
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Visual Analogue Scale (VAS) (pain)
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VAS (fatigue)
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5-point Likert Scale (enjoyment)
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5-point Likert Scale (perceived benefit).
Therapists involved in the delivery of the JRS WAVE will be invited to complete an anonymous survey that asks for their feedback on the utility of the system. Perspectives on potential benefits and harm will also be recorded.
Data Collection
Flow through the study is identified in Fig. 1.
Data analysis
Data collected during the trial will allow us to describe the participants’ changes in upper-limb function, balance and mobility by using t tests or Mann–Whitney U tests to compare normally and non-normally distributed data, respectively. Repeated measures analysis of variance will be used to compare changes in the outcome measures over time and between groups (intervention versus control). The level of significance will be set at 0.05.