None listed
Conditions
Brief summary
A large proportion of stroke survivors experience loss of arm and communication functions at 3 months post-stroke. These effects are extremely debilitating and can result in long term disability. The aim of this study is to identify the most promising model of arm and communication rehabilitation for people 3 to 24 months after stroke who are living in the community. It is hypothesised that at least one promising UPLIFT model of rehabilitation combining upper limb and language rehabilitation can be identified and taken forward to further clinical trials and translation into the clinic. Participants shall complete some baseline assessments to determine their level of disability, then undertake a 4 week intervention program. The intervention will be intensive daily training (2 or 4 hours/day), either in person or via telerehabilitation, involving both arm training and communication training. Rehabilitation focuses on combining impairment and functional training for tasks such as reaching to pick up a cup of coffee, with contextual everyday communication such as asking for a cup of coffee, and integration of the two, i.e. reaching to pick up a cup of coffee and saying ‘thank you’ while doing it. Baseline assessments will be repeated at the conclusion of the 4 week intervention period. Participants shall be closely monitored for adverse events throughout the intervention program.
Interventions
A 4 week intervention program involving intensive daily training sessions (5 days per week for 2 or 4 hours/day), either in person or via telehealth, incorporating both upper limb (arm) training and language (communication) training. Participants will be randomly allocated to one of four intervention groups, depending upon their degree of stroke-related disability.
Participants shall be assessed to determine their baseline severity of impairment, then assigned to either:
-telerehabilitation
A 4 week intervention program involving intensive daily training sessions (5 days per week for 2 or 4 hours/day), either in person or via telehealth, incorporating both upper limb (arm) training and language (communication) training. Participants will be randomly allocated to one of four intervention groups, depending upon their degree of stroke-related disability. Participants shall be assessed to determine their baseline severity of impairment, then assigned to either: -telerehabilitation at home (if both arm and communication impairments are mild or moderate severity), or - in-person intervention in the clinic (if at least one of arm or communication impairment is severe). Participants will subsequently be stratified by time post stroke (either 3-12 months or 12-24months), then randomised to either 2 or 4 hours of intervention/day for 4 weeks. Upper limb training will focus on impairment and functional training of the arm and hand. Impairment training will target strength, control, coordination and flexibility. Functional training will target reaching, grasping, manipulating and releasing an object to maximise function and transition to use in real-world tasks. For people with severe impairment, electrical stimulation will be used to make practice possible. Language training will target both language impairment and everyday communication in context.Training will target deficits at the word, sentence, and conversational level in comprehension and production. Communication in context will focus on communicative effectiveness in relevant everyday situations through multiple modalities (ie, gestures, speech, writing). All training will be delivered one-on-one by qualified Physiotherapists, Occupational Therapists, Speech Pathologists and Allied Health Assistants that have undergone study specific training. To monitor adherence to the intervention, for each training session, a detailed record of dose and intervention content will be recorded.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People with stroke will be screened against the following inclusion criteria: • Adults greater than or equal to 18 years with a clinical diagnosis of hemispheric stroke (ischaemic/haemorrhagic) between 3 to 24 months prior to recruitment • First stroke, or if repeat stroke, no residual arm or language deficit from prior stroke(s) • Presence of upper limb impairment (at minimum, must have at least a flicker of movement somewhere) and language impairment (aphasia; at minimum, must have at least single interpretable word output) after stroke • Appropriate candidate for therapy in the home if required, and willingness to use the required technology (or assistance available at home to help) • Able to follow single stage commands, provide informed consent, or medical decision maker can if required
Exclusion criteria
People will be excluded if they have: • Baseline scores that prevent achieving required change on at least one priority outcome • No residual upper limb and language deficits from a previous stroke • Severe comorbid medical illness, neurological condition, psychiatric illness or other medical diagnosis deemed by the investigator to make a participant unlikely to be able to fully participate in all study procedures including attendance at a site for baseline and post-intervention assessments • Life expectancy less than 3 months
Outcome results
None listed