Feasibility Study and Pilot RCT Into the Use of a Novel Technology to Train Sitting Balance and Trunk Control

The primary outcome of the study is to investigate the feasibility of trunk therapy performed on the T-Chair in persons in the subacute phase post stroke. This will be done through the measurement of demand, safety, handling, acceptance, comfort, exertion of exercises and general feedback. Data will be collected through a therapy diary consisting of various questions regarding feasibility of the device.

Trunk function will be assessed with the Trunk Impairment Scale (TIS). The Trunk Impairment Scale evaluates static and dynamic sitting balance and trunk coordination on a 17-item ordinal scale. The score ranges from 0 to 23 points, a higher score indicates better functioning of the trunk.

Strength will be measured in Newton with a hand-held dynamometer (MicroFet 2). A variety of trunk and lower limb muscle groups will be measured: Trunk Flexion, Trunk Extension, Trunk Lateral flexion bilaterally, Trunk Rotation, bilaterally, Hip Flexion, Hip Extension, Knee Extension and Knee Flexion.

For each muscle group, the patient gets two attempts. The highest value will be recorded.

The Fugl-Meyer assessment scale will be used to evaluate selective movements of the lower extremity. The motor score includes assessment of reflexes, coordination and joint movements of the hip, knee and ankle. The score for the lower-extremity part ranges from 0 to 34 points. A higher score represents a better motor function.

The limits of stability test, is a measurement performed seated on a force platform whereby the maximum centre of pressure displacement during a leaning task is assessed. The participant will be asked through feedback on a screen to lean as far as possible toward eight directions, without loss of balance. The software calculates the maximum centre of pressure displacement, reaction time to start the movement and the direction control.

The Functional Ambulation Categories is a score of how much help the participant needs with his balance and/or carrying its weight while walking. The score ranges from 0 to 5, with 0 meaning not able to ambulate, and 5 meaning able to ambulate without help on uneven grounds and stairs.

Mobility is assessed with the Timed up and Go Test. Hereby the participant has to stand up from a chair, walk 3 meters, make a turn and walk back to the chair. The test stops as soon as the patient is seated back on the chair. The time used to perform the exercise and the type of walking aid are recorded.

The Montreal Cognitive Assessment (MoCa) version 8.0 assesses attention, concentration, executive functions, memory, language, visual-constructional skills, conceptual thinking, calculations and orientation. This questionnaire has been officially translated multiple languages, among which German. It contains 11 items with a maximum score of 30 points. The level of education is taken into account in this test. Scores of 26 points and higher are considered normal.

The star cancellation test is a screening tool to evaluate unilateral spatial neglect, measured in the extra personal space. The test form contains 52 large stars, 13 letters, 10 short words and 56 small stars. The test form is placed in front of the participant on his or her midline. The participant is asked to cross out all of the small stars. Before the start of the test two small stars are crossed out to demonstrate the test. The maximum score of this test is 54 points. A star ratio will be calculated, whereby the total amount of small stars that are crossed out on the left side of the page are divided by the total stars crossed out by the patient on the whole page.