Augmented Upper Limb Physiotherapy for Acute Stroke Survivors Undergoing Inpatient Stroke Rehabilitation; a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Adherence to augmented web-base physiotherapy programme
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stroke survivors
- •moderate to severe upper limb functional limitation due to stroke (score 0-39 in the Action Research Arm Test (ARAT))
- •shoulder subluxation who scored less than grade 3 (less than 1 1∕2 fingerbreadth gap) in the measure of shoulder subluxation
- •diagnosed with first stroke and admitted to the rehabilitation unit
- •able to sit in a chair or a bed
- •able to use computer or tablet with or without help from carers
- •able to understand the English language
- •able to provide informed written consent
- •able to support the patient in the augmented programme (intervention group)
- •able to understand and speak the English language
- •Physiotherapy staff
- •able to deliver and monitor the augmented programme
Exclusion Criteria
- •Stroke survivors
- •significant cardiorespiratory, orthopaedic, neurological or other condition that would preclude them from taking part in an exercise programme
- •moderate to severe cognitive impairment (score less than 25 in the Mini Mental State Examination (MMSE)
- •current participation in another project
- •No exclusion criteria for carers and physiotherapists
Arms & Interventions
Upper limb physiotherapy programme
A progressive, individualised four week upper limb physiotherapy intervention programme delivered via web-based physiotherapy lasting up to 30 minutes/session, five times per week + usual care.
Intervention: Upper limb physiotherapy programme (Other)
Upper limb physiotherapy programme
A progressive, individualised four week upper limb physiotherapy intervention programme delivered via web-based physiotherapy lasting up to 30 minutes/session, five times per week + usual care.
Intervention: Usual care (Other)
Usual care
An average of 4 to 5 physiotherapy sessions per week, lasting approximately 45 minutes each.
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Adherence to augmented web-base physiotherapy programme
Time Frame: 4 weeks
Number of completed exercise sessions
Feasibility of recruitment strategy
Time Frame: 11 month recruitment period
Number meeting the inclusion criteria invited/agreeing to participate
Participant attrition
Time Frame: 1 year study period
Number of participants dropping out of the study
Participant safety - adverse events
Time Frame: 1 year study period
Number of Adverse Events
Secondary Outcomes
- Upper limb function(Baseline to week 4)
- Trunk Function(Baseline to week 4)
- Spasticity (MAS)(Baseline to week 4)
- Spasticity (MTS)(Baseline to week 4)
- Participant feedback(Week 4)
- Stroke severity(Baseline to week 4)
- Post-stroke function(Baseline to week 4)