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

Jan Kool32 enrolled

Overview

Additional trunk therapy is proven to be effective for improving trunk function and sitting balance. However, conventional trunk therapy is limited by the needed supervision of a therapist and when using unstable surfaces, only a small patient group can profit from this training. Rehabilitation technologies are considered an effective add-on to conventional therapy in order to improve semi-independent training at a high-intensity for a broad type of patients. For the trunk, only few devices exist, mainly used for research purposes and not adapted to clinical needs. Therefore, a prototype to train the trunk of the patient was developed (T-Chair), in order to train trunk control and sitting balance. After the first usability study with the first T-Chair prototype, it was found that the device was usable and safe but it needed further improvements. Over the past year these improvements have been made. Therefore the goal of this feasibility study is to investigate the usability of the new T-Chair 2.0 prototype, as well as the possible effect the device could have on trunk control and lower extremity function. To do this, 30 persons in the subacute phase post stroke will be included in the study and randomly assigned to the experimental or control group. Participants in the experimental group will perform in addition to their normal general rehabilitation programme, additional therapy with the T-Chair 2.0, three times per week for four weeks. Participants in the control group will perform their normal general rehabilitation programme. Before training at T0, trunk function, trunk muscle strength, lower extremity function, lower extremity muscle strength, sitting balance, general mobility, cognition and level of neglect will be evaluated. Directly after each therapy session feasibility in terms of demand, safety, handling, acceptance, comfort, exertion of exercises and general feedback will be evaluated. After four weeks at T1, all measurements will be repeated.

In 2016, 14.608 people suffered a stroke in Switzerland alone, causing impairment in cognitive, psychological and motor functions. One of the most well-known symptoms is a hemiplegia, causing the patient to lose muscle force and sensibility on one body side. Mostly unknown, is that the trunk is affected bilaterally, causing the patient to have problems with sitting or standing balance and being unable to execute simple tasks in daily life. As trunk function is a strong prognostic factor for independence in daily life, it is a key component in rehabilitation after stroke. Additional trunk therapy is proven to be effective for improving trunk function and sitting balance. However, conventional trunk therapy is limited by the needed supervision of a therapist and when using unstable surfaces, only a small patient group can profit from this training. Rehabilitation technologies are considered an effective add-on to conventional therapy in order to improve semi-independent training at a high-intensity for a broad type of patients. For the trunk, only few devices exist, mainly used for research purposes and not adapted to clinical needs. Therefore, a prototype to train the trunk of the patient was developed (T-Chair), in order to train trunk control and sitting balance. The feasibility of the first prototype was tested in a previous study. Outcomes have been used to improve the prototype in order to produce the final prototype: the T-Chair 2.0. In order to know if this final device suits the needs of patients and therapist and has an effect on trunk and lower extremity function after stroke a feasibility study combined with a pilot randomised controlled trial will be performed.

Interventions

T-Chair 2.0 PrototypeDEVICE

Participants in the experimental group will perform additional therapy with the T-Chair 2.0. Participants can train in two modes. Participants will either train in the active modus, whereby the participant has to move the seat in a certain direction, or in the passive modus, whereby the participant has to stay in a stable position while the seat is moving underneath the participant. The seat is able to move in mediolateral, anteroposterior, and diagonal and combined directions such as circles or eight-figures. The modus, the type of movement, the range of motion and speed of movement are chosen by the therapist according to the patients' abilities.Training will be coupled with a computer based exercise. During the session preparation time, and time for the questionnaires is needed, thus we expect the actual training time to be on average 30 minutes per training.

General Rehabilitation ProgrammeOTHER

The general rehabilitation program that is offered to all patients of Clinic Valens fits the current standards for treatment post-stroke. This program is tailored to the patients needs and consists of a 90 minute so called "focus training" per day, which includes physical therapy, occupational therapy, resistance training and gait training. According to the patient needs, extra therapy will be given such as robotic therapy, speech therapy and aquatic therapy. The general rehabilitation program in both groups is comparable in content, time and intensity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of a recent stroke, a previous stroke is allowed when full recovery was reached * Impairment of trunk function, meaning a Trunk Impairment Scale between 2 and ≤19 points * Able to sit independently for 2 minutes * Being admitted as an inpatient to the Rehabilitation Clinic Valens * Older than 18 years * Language and cognitive functions on such a level that participants are able to understand and execute instructions that are needed to complete the therapy in a satisfying manner. Exclusion Criteria: * Not able to give informed consent * Unable to understand and execute instructions in a satisfying manner. * Other neurological diseases of the central nervous system, such as multiple sclerosis, Parkinson, etc. * Co-Morbidities that influence trunk function and sitting balance, such as other musculoskeletal or other neurological diseases. * Pregnancy

Outcomes

Primary Outcomes

Feasibility Parameters

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.

Time frame: Up to two hours after treatment

Secondary Outcomes

Trunk Impairment Scale

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.