No registrations found.
ID
Source
Brief title
Health condition
Stroke
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Secondary outcome
Action Research Arm Test (ARAT), ABILHAND, Client Sastisfaction Questionnaire (CSQ-8), Physical Enjoyment Scale (PACES-8), NASA-TLX, Visual Analogue Scale (VAS), active minutes (using Actigraph)
Background summary
Background
After stroke, 69 -88% of the patients have upper limb paresis. Task specific training has proven to be effective to increase upper limb function. However providing individual task specific training is time demanding, expensive and mentally demanding for therapists. To lower the pressure for therapists, it has been proposed to train in groups with different work stations, also known as class circuit training (CCT). The therapist has prepared a set of workstations that are used to train activities of daily living (ADL). In the literature, no studies exist that investigate CCT for the upper extremity using ADL activities.
Main research question
The aim of this pilot is to compare the effectiveness of CCT to usual care (UC) on the improvement of arm/hand function in patients in the subacute phase of stroke. Secondary objectives are to investigate the patient satisfaction, therapist load and active time during therapy sessions.
Design (including population)
Subacute stroke patients, admitted to the rehabilitation ward. Patients should be able to perform finger flexion and have movement in the shoulder.
In this non-randomized pilot, patients will train 4 weeks in either the CCT group or the UC group, based on when they enter the study.
Outcomes are arm function tests, questionnaires about the enjoyment, mental and physical load, satisfaction with therapy, perceived improvement and pain. Once a week, activity is monitored in a session.
Expected results
We expect that patients train more different skills at the same time during CCT and therefore we think that the arm function will improve more in comparison to UC.
Study objective
Patients improve more in upper limb function after CCT in comparison to usual care.
Patients are equally satisfied with both CCT and usual care as therapy.
Patients have more active minutes during CCT in comparison to usual care.
Study design
Patients that enter the rehabilitation center will be checked for eligibility. The patient is measured before the start of the intervention (pre) and after 4 weeks of intervention (post). The VAS, containing questions regarding pain and perceived improvement of arm function, will be asked daily. The PACES-8, NASA-TLX and Actigraph are measured once a week on Friday. The CSQ-8 will be asked at the end of the study (post)
Intervention
Class Circuit Training (CCT): The therapist has prepared a set of standardized workstations that are used to train activities of daily living (ADL). During CCT, patients train intensive repetitive task specific activities in small groups at the work stations.
Usual care: The therapist and patient have defined goals that are worked on during group therapy. This can be either alone or together with other patients.
Inclusion criteria
Patients: Adult patients within 4 weeks of first stroke onset, who did not started rehabilitation therapy yet. Patients should be able to perform finger extension 3 times (FMA extension ≥ 1) and shoulder abduction (Motricity Index > 14). Patients should be able to understand and execute simple instructions, understand the Dutch language and be able to provide informed consent.
Exclusion criteria
Patients: Severe aphasia, severe cognitive problems (Montreal Cognitive Assessment≤20), severe neglect (star cancellation test≤44), severe spasticity (Passive Resistive to Passive Movement ≥4), severe pain (VAS≥60) and severe sensory problems (Erasmus modification Notthingham Sensory Assessment≤24). Cannot hold attention to task for 2 minutes.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8844 |
| Other | METC Groningen : METc 2020/413 |