Stroke Clinical Trial
Official title:
Augmented Upper Limb Physiotherapy for Acute Stroke Survivors Undergoing Inpatient Stroke Rehabilitation; a Feasibility Study
Verified date | December 2019 |
Source | NHS Greater Glasgow and Clyde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 26, 2019 |
Est. primary completion date | August 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Carers - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Lanarkshire | Hamilton |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | Glasgow Caledonian University, NHS Lanarkshire, University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to augmented web-base physiotherapy programme | Number of completed exercise sessions | 4 weeks | |
Primary | Feasibility of recruitment strategy | Number meeting the inclusion criteria invited/agreeing to participate | 11 month recruitment period | |
Primary | Participant attrition | Number of participants dropping out of the study | 1 year study period | |
Primary | Participant safety - adverse events | Number of Adverse Events | 1 year study period | |
Secondary | Upper limb function | Change in score on Action Research Arm Test (ARAT) | Baseline to week 4 | |
Secondary | Trunk Function | Change in score on Trunk Impairment Scale (TIS) The TIS is a 17-item measure for assessing the level of motor impairment of the trunk in stroke survivors e.g. coordination and sitting balance (static and dynamic). The scores range from 0 to 23 with lower scores indicating high levels of motor deficit in the trunk. | Baseline to week 4 | |
Secondary | Spasticity (MAS) | Change in score on Modified Ashworth Scale (MAS) The MAS is a scale used to measure the level of spasticity in people with neurological conditions. The MAS scores range from 0 to 4, with higher scores indicating an increase in muscle tone. | Baseline to week 4 | |
Secondary | Spasticity (MTS) | Change in score on Modified Tardieu Scale (MTS) The MTS is a valid, reliable scale for measure the level of spasticity in patient with neurological conditions. In terms of quality of muscle reaction, the score ranges from 0 to 5, where a score of 0 means that the muscle is not spastic while a score of 5 means that the muscle is spastic and immobile. In terms of angle of muscle reaction, the score is R1 or R2, where R1 means the joint demonstrates limited passive range of motion while R2 means the joint demonstrate full passive range of motion. | Baseline to week 4 | |
Secondary | Participant feedback | Qualitative responses to evaluation questionnaire | Week 4 | |
Secondary | Stroke severity | Change in score on National Institutes of Health Stroke Scale (NIHSS) The NIHSS is a valid and reliable tool to assess the severity of stroke. The NIHSS scale is scored from 0 to 42, with higher scores indicating higher stroke severity. | Baseline to week 4 | |
Secondary | Post-stroke function | Change in score on modified Rankin Scale (mRS) The mRS is a tool to assess level of function after stroke. The highest score is 5 which reflects severe disability and inability to perform daily activities after stroke. The lowest score is 0 which reflect individuals having a normal life with no symptoms of disability after stroke. | Baseline to week 4 |
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