Patients in the chronic stage after a stroke
Conditions
Interventions
The treatment concept investigated in this RCT is the so-called ReHab-TOAT (Remote Handling Based Task-Oriented Arm Training). The remote handling device which is used within this treatment, i.e. the
Sponsors
Adelante Zorggroep
Eligibility
Inclusion criteria
Inclusion criteria: For the chronic stroke patients (n=30) to be eligible to participate in this study, they must meet all of the following criteria: - An unilateral stroke (ischemic or haemorrhagic) confirmed by brain imaging; - Post-stroke time larger than 12 months; - Hemiplegic pattern of arm motor impairment with UAT score 1-3 [41]; - Age 18 years or more; - Sufficient cognitive level, i.e. being able to understand the questionnaires and measurement instructions. Patients' caregivers (n=30) should meet the following inclusion criteria: - Age 18 years or older; - providing informal care to stroke patients from the group mentioned above.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in this study: - Severe non-stroke related co-morbidity that may interfere with arm-hand function. - Additional complaints that may interfere with the execution of the measurements. - Spasticity in the affected upper limb, i.e. a Modified Ashworth Scale (MAS) score = 1+ [65]. - Severe cognitive problems that prevent the patient from understanding the tasks. - Prior participation in the ReHab-TOAT pilot study (CCMO code: NL70014.015.19). - No informed consent. Exclusion criteria for patients' caregivers are: - No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brunnstrom-Fugl Meyer Test: The BFMT consists of various separate sections. For this study only the section assessing motor function of the arm, wrist and hand is used. The 33 items assess movements, reflexes and coordination of the shoulder, elbow, wrist and hand. | — |
Secondary
| Measure | Time frame |
|---|---|
| Action Research Arm Test (ARAT): The ARAT consists of four subtests comprising 16 grasp movements and three reaching movements to be performed by the patient. Motor Activity Log (MAL): The MAL is a semi-structured interview to assess frequency of use (AU) (“How often did you actually use your affected arm for this activity ?”, 6 point likert scale: 0= not used/ 5=same as pre-stroke) and quality of use (QU) (“How useful was the contribution of your affected arm during this activity?”, 6 point likert scale: 0=no contribution/5=same as pre-stroke) of the affected limb for skill performance. Accelerometry: As to actual arm-hand skill performance, wrist-watch-like activity monitors (3D accelerometers/gyroscopes, AX6, Axivity Ltd, UK) (dimensions: 23 x 32.5 x 8.9 mm; weight: 11 gram) will be worn around both wrists for a period of 5 consecutive days. Signals from these sensors will be analysed to gauge the actual amount of arm-hand use during daytime. EuroQoL-5D: The EuroQol-5D (EQ-5D) is a broad generic assessment tool for quality of life[83]. It includes a Visual Analogue Scale (VAS) (0-100) to indicate the perceived health-state, as well as scoring of 5 sub-items (0-2 score) (mobility, self-care, usual activities, pain, and anxiety). CarerQoL: The care-related Quality of Life instrument (CarerQoL) is a questionnaire which measures the subjective burden of providing informal care. It combines a subjective burden measure of the caregivers situation with a valuation of personal well-being on a VAS. Single question for caregivers on amount of support provided: In addition to the CarerQoL one single question will be asked to measure the amount of support the caregiver has to provide. Single question for patients: A single question gauging the occurrence of any event over the last 2 weeks that may influence the results of the treatment or the measurements (e.g. the patient having had the flu in the past 2 weeks) will be posed. Single question for caregivers: | — |
Contacts
Public ContactHenk Seelen
Adelante Zorggroep
Outcome results
None listed