None listed
Conditions
Brief summary
Stroke is a major public health challenge in New Zealand. As well as the personal burden carried by those with stroke, there is a considerable financial cost to the nation, for hospital, community and institutional care. As the population ages, the number affected by stroke is projected to increase significantly. Two important treatment modalities for maximising function after stroke is Mirror therapy and FES. Mirror therapy takes advantage of visual stimuli to regain function through motor imagery. Participants observe their unaffected limb performing a functional task while attempting to mimic that task on their affected side. FES is a relatively new treatment option for adults after stroke. FES involves electrical stimulation whilst undertaking specific tasks, such as applying electrical stimulation to an impaired arm, whilst attempting to lift a cup. Despite the encouraging results, FES does not form part of a standardised approach as evidence is incomplete and no protocols are available that allow FES to be readily employed by therapists and nurses. Further, there are no studies that evaluate the impact of using FES in people in the acute stages following stroke. This randomised controlled trial will seek to compare the impact between early intervention FES, Mirror Therapy and combined FES with Mirror therapy on 100 adults with impaired upper limbs following stroke. The study will explore the effect of these interventions on activities of daily living (such as writing letters, making a cup of tea and getting washed and dressed) as well as hospital length of stay. This study will not only allow a thorough and robust exploration of FES and Mirror Therapy, but moreover if successful allow the development of protocols to be used nationally and internationally and build capacity within the unit in both clinical skills and research.
Interventions
Participants will be randomly assigned to the FES group, Mirror Therapy group or the combined FES with Mirror therapy group.
The FES group will involve individually tailored progressive programmes beginning with a session of 20 minutes and progressing each day as tolerated. At the same time the participants will receive two half hour sessions of task specific training each day. The goal will be to have 30-minute FES sessions twice daily, concurrently with two 30 minute sessions of task-specifi
Participants will be randomly assigned to the FES group, Mirror Therapy group or the combined FES with Mirror therapy group. The FES group will involve individually tailored progressive programmes beginning with a session of 20 minutes and progressing each day as tolerated. At the same time the participants will receive two half hour sessions of task specific training each day. The goal will be to have 30-minute FES sessions twice daily, concurrently with two 30 minute sessions of task-specific exercise, and the rest of the daily sessions will be limited to FES without specific exercises. The FES parameters will be set to run at a rate of 45Hz with a pulse width of 200 micro seconds using a synchronous current. The ramp up time of 1sec, ramp down time of 0.8sec and overall work:rest ratio of 8sec:8sec will be fixed throughout the study however session times will progress as tolerated. Surface electrode placement is reproducible using known landmarks of motor point anatomy used in EMG practical manuals. The mirror therapy group will be provided with 30-minute mirror therapy sessions twice daily, in addition to two half hour sessions daily of task specific exercises. The mirror therapy sessions will involve progressively difficult functional tasks performed by the unaffected upper limb while attempting to mimic these tasks with the affected upper limb within the mirror-box. The FES & Mirror therapy combined group will undergo 30-minute sessions twice daily, in addition to two half hour sessions daily of task specific exercises. These sessions will replicate the tasks performed within the mirror therapy group and the FES electrode placement will mimic that of the FES alone group. The duration of treatment for each participant will continue throughout their stay within the Comprehensive Stroke Unit - approximately 4-6 weeks. FES and Mirror Therapy will be administered by a research physiotherapist in a group setting (one physiotherapist with up to four participants), while the two half hour sessions daily of task specific exercises will be administered by ward based allied health staff.
Sponsors
Dr John Parsons
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a) Over 18 years; (b) Admitted to Waikato Hospital with a confirmed diagnosis of stroke; (c) Living in the community within the Hamilton area on admission to hospital; (d) Has a score of greater than 16/30 on Montreal Cognitive Assessment; and (e) Has an Action Research Arm Test (ARAT) score of <30/57
Exclusion criteria
Clinicians may consider a patient unsuitable to enroll if they have any of the following: (a) Severe cognitive impairment (<16/30 on the Montreal Cognitive Assessment); (b) Severe or unstable cardiovascular disease (i.e. unstable angina, pacemaker fitted, dysrhythmia other than controlled atrial fibrillation); (c) Near-terminal disease (including advanced lung, heart, kidney, liver failure resistant to medical management); (d) Acute Musculoskeletal Disorder
Outcome results
None listed