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

NCT04440748 | Completed

• 1 other identifier: T-Chair 2.0
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation; Novel Technology; Trunk Control; Sitting Balance

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to two hours after treatment

Secondary Outcomes (8)

• Trunk Impairment Scale

  Baseline and through study completion, on average after 28 days.

• Muscle Strength of the lower extremity muscles and trunk muscles

  Baseline and through study completion, on average after 28 days.

• Fugl-Meyer Assessment of the lower extremities

  Baseline and through study completion, on average after 28 days.

• Sitting balance: Limits of stability

  Baseline and through study completion, on average after 28 days.

• Functional Ambulation Categories

  Baseline and through study completion, on average after 28 days.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will perform additional high-intensity therapy on the T-Chair 2.0, which is a newly developed non-CE-marked prototype to train trunk control and sitting balance. This they will do in addition to their normal rehabilitation program.

Device: T-Chair 2.0 Prototype; Other: General Rehabilitation Programme

Control Group

ACTIVE COMPARATOR

Participants in the control group will execute their normal rehabilitation program.

Other: General Rehabilitation Programme

Interventions

T-Chair 2.0 Prototype DEVICE

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.

Experimental Group

General Rehabilitation Programme OTHER

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Kool: lead
• KU Leuven: collaborator
• ZHAW School of Health Professions, Institute of Physiotherapy: collaborator
• ZHAW School of Engineering: collaborator

Study Sites (1)

Klinik Valens

Valens, 7317, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jan Kool, PhD

  Klinik Valens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcome Assessor will be blinded for the allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. PhD

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 22, 2020
• Study Start: April 8, 2021
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)