Clinical trial NCT04440748: Feasibility Study and Pilot RCT Into the Use of a Novel Technology to Train Sitting Balance and Trunk Control
Official title: Feasibility Study and Pilot Randomized Controlled Trial Into the Use of a Novel Technology to Train Sitting Balance and Trunk Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Novel Technology
Trunk Control
Sitting Balance
Lead sponsor: Klinik Valens
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: ZHAW School of Health Professions, Institute of Physiotherapy
name: ZHAW School of Engineering
First posted: 2020-06-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility Parameters
timeFrame: Up to two hours after treatment
Secondary outcomes:
measure: Trunk Impairment Scale
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Muscle Strength of the lower extremity muscles and trunk muscles
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Fugl-Meyer Assessment of the lower extremities
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Sitting balance: Limits of stability
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Functional Ambulation Categories
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Timed Up and Go Test
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Montreal Cognitive Assessment (MoCa)
timeFrame: Baseline and through study completion, on average after 28 days.
measure: Star cancellation test
timeFrame: Baseline and through study completion, on average after 28 days.
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Klinik Valens
Study officials:
affiliation: Klinik Valens
name: Jan Kool, PhD
role: STUDY_DIRECTOR
References: