se of an individualised, task-oriented, video-supported home exercise programme in people after subacute stroke with mild to moderate arm paresis: a randomised, single blinded, controlled feasibility study
- Conditions
- I69Sequelae of cerebrovascular disease
- Registration Number
- DRKS00023395
- Lead Sponsor
- Medizinische Universität Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1) People after a first-ever stroke
2) =18 years of age
3) mild to moderate arm paresis, assessed by the Motricity Index [MI]: minimum pinch grip of 19 points, elbow flexion / shoulder abduction of 14 points
4) patients at the subacute phase, from 7 days to 5 months after a stroke
5) patients after discharge from the hospital or living at home
6) sufficient cognitive abilities (Mini Mental Status Test =24)
7) resident of Tyrol
8) written informed consent
1) Stroke in medical history
2) <18 years of age
3) lack of residual motor skills in the shoulder, wrist and fingers
4) modified Rankin Scale (mRS) = 4
5) comorbidity which would restrain participation, e.g. life expectancy of less than 12 months, malignant disease.
6) any physical or mental condition restricting participation in the study, e.g. heart failure, trustee, serious neuropsychological disorders, neglect, severe aphasia, severe cognitive deficits - dementia, psychiatric disorders, hemianopia, severe visual impairment
7) pregnancy
8) military service providers
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of the methods and of a larger randomised controlled trial that will investigate the effects of an individualised, task-oriented, video-supported home exercise programme versus an individualised, task-oriented, paper-based home exercise programme in subacute patients after stroke with mild to moderate arm paresis (evaluated by predefined feasibility criteria: eligibility rate , recruitment rate, retention rate, adherence rate, safety and adverse events).<br>Baseline assessment (T0), Post-intervention assessment (28+/-2 day, T1), Follow-up assessment (1 month after Post-intervention assessment, T2)
- Secondary Outcome Measures
Name Time Method Change in the use of the affected upper extremity in activities of daily living as measured by the Motor Activity Log-30 [MAL-30], arm function as measured by the Action Research Arm Test [ARAT], fine motor skills of the hand as assessed by the Nine Hole Peg Test [NHPT], gross motor skills of the hand as measured by the Box and Block Test [BBT], hand strength as measured by a Jamar hand dynamometer, activity and participation as assessed by the Score of Independence for Neurologic and Geriatric Rehabilitation [SINGER], health-related quality of life as measured by the European Quality of Life-5 Dimensions [EQ-5D-5L], patient-relevant goals at the activity and participation levels as assessed by Goal Attainment Scaling [GAS], and patient satisfaction and acceptance as evaluated by a semi-structured interview.<br>Baseline assessment (T0), Post-intervention assessment (28+/-2 day, T1), Follow-up assessment (1 month after Post-intervention assessment, T2)