Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2023
INTERVENTION: Participants will complete upper‐limb sensorimotor rehabilitation addressing identified impairments to improve upper‐limb function. Individualised programs will be based on initial assessments and rehabilitation goals. All participants will complete a 5‐week program delivering 90 hours of therapy (18h per week) comprising: 1) An upper‐limb group exercise class (ratio 4:1), 2) Rehabilitation technologies (for example, robotics, virtual reality, EEG EMG biofeedback, non‐immersive gaming, functional electrical stimulation and interactive multisensory gaming technologies, 3) task‐specific training (1:1), 4) A home exercise program based on the Graded Repetitive Arm Supplementary Program (GRASP) or pre‐recorded videos such as Different Strokes UK YouTube (informed by impairment level and patient preference). The 18h per week will be achieved by 13h delivered in person (based on tasks above) and 5h of home exercises (1h per weekday, recorded in an activity log). Adherence to both the in person and home program will be recorded. Each 5 week program will have a maximum of 4 patients. All therapy sessions will be delivered by a Physiotherapist and supported by Physiotherapy and Occupational Therapy students. There will be a minimum of 5 week washout between arms of the trial. CONDITION: Physical Medicine / Rehabilitation ‐ Physiotherapy Stroke ‐ Haemorrhagic Stroke ‐ Ischaemic stroke; ; stroke PRIMARY OUTCOME: Feasibility of delivering an intensive rehabilitation program. This will be assessed against the following criteria. If all 4 criteria are met, this program will be considered feasible.; 1) greater than 50% of eligible participants who express interest in this project go on to consent to participate (determined from recruitment and consent rates in recruitment logs); 2) greater than 80% of participants achieve 18h of therapy a week (determined from exercise logs); 3) greater than 80% of participants complete 5 weeks of the program (determined from attendance logs) and ; 4) greater than 80% of participants report the program was useful, helpful and acceptable (Likert scales at least =4/5, determined at end of intervention).[End of intervention] INCLUSION CRITERIA: People with chronic stroke (greater than 3 months post ictus) will be recruited. INCLUSION CRITERIA: Aged at least 18 years, discharged from rehabilitation, any upper‐limb sensorimotor impairment (determined by Fugl‐Meyer Upper Limb assessment, scoring less than or equal to 62/66). SECONDARY OUTCOME: Safety ; Treatment‐emergent adverse events will be defined as any event not present prior to initiation of the treatment, or any event already present that worsens in either intensity or frequency following initiation of treatment. ; Determined by participant report at end of intervention and observations by clinicians. [End of intervention] Stroke Self‐Efficacy Questionnaire[Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).] Stroke‐Specific Quality of Life Scale[Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).] Upper Limb Activity (Action Research Arm Test)[Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).] Upper limb motor impairment (Fugl‐Meyer)[Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).]
Epistemonikos ID: b8d32cc756d504485b2786ff720243ddde2a2c7c
First added on: Feb 20, 2024