Providing Sitting Balance Training With a Newly Developed Rehabilitation Device

NCT ID: NCT04467554

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-07-13

Brief Summary

This clinical study is being conducted to evaluate a new training device, the T-CHAIR, for trunk rehabilitation and post-stroke balance. The investigators would like to study three objectives. First, the investigators want to examine whether training with a new training device is feasible and safe during rehabilitation in the later phase, more than six months after a stroke. The investigators also evaluate whether training with a new training device has an effect on the sitting balance and the function and strength of the trunk. Finally, the investigators examine whether training with a new training device has an effect on walking, standing and activities of daily life and self-care.

Detailed Description

The primary goal of this study is to evaluate safety, acceptance and feasibility when participants in the chronic phase after a stroke train with this newly developed trainings device. Secondly, the investigators will evaluate the effect of training with this device on secondary outcome parameters such as trunk function, standing and sitting balance, gait and selective movement. The investigators compare the effect on secondary outcomes of the experimental intervention with a control intervention using a randomized controlled trial. Both groups include participants in the chronic phase post-stroke.

TRIAL OBJECTIVES AND PURPOSE

The primary objective of the proposed project is to investigate the feasibility and safety of sitting balance training on the T-chair, in the chronic phase (>6 months) after stroke.

The second objective of the study is to investigate if utilizing the T-chair has an effect on sitting balance, trunk function and trunk strength in participants post stroke, in comparison to conventional therapy.

Thirdly, the investigators will examine if training on the T-chair has an effect on other parameters, such as gait, balance, activities of daily living and reintegration in community.

TYPE AND DESIGN OF THE TRIAL WITH HYPOTHESIS

This study is a monocenter randomized controlled trial, evaluating participants in the chronic phase (>6 months) after stroke. This study will be performed in a rehabilitation center (outpatient department) in Belgium. In this study two groups will be included; the experimental group will receive usual therapy plus additional training on the T-chair, the control group will receive usual therapy only. The investigators believe this is feasible to provide only additional therapy in the experimental group, as our trial is designed to examine the effect of a specific type of additional therapy (independent sitting balance training), and not to compare the effect of one therapy over another kind of therapy.

Hypotheses:

1. The T-chair is a safe and feasible training device, to train trunk function in the subacute and chronic phase after stroke.

2. Training on the T-chair has a positive effect on trunk function and strength compared to conventional therapy.

3. Training on the T-chair has a positive effect on balance, gait, walking endurance, walking speed, activities of daily living, level of disability and change in patient status compared to conventional therapy.

ASSESSMENT

Data such as age, date of stroke, type of stroke, localization of stroke, comorbidities, dominant hand, educational level and gender are registered. Testing will be performed three times.

Two test moments at baseline, with an interval of 2 weeks. The third test moment will be conducted after the after the four weeks intervention.

The investigators evaluate feasibility and effect of sitting balance training with different standardized measures. All the outcome measures will be assessed using clinical measurement tools, whereby the investigators evaluated trunk selectivity and strength, leg selectivity and strength, walking abilities, level of functional performance and balance. Trunk strength will be assessed with a hand dynanometer and trunk stability with a balance platform BioRescue (RM Ingénierie, France).

The psychometric properties of the majority of the measurement tools were evaluated through a literature search. The investigators found a high interrater reliability, ranging from 0.74 to 0.99 and an excellent test-retest reliability, ranging from 0.90 to 0.99.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Measurements and T-chair training

This group will receive three measurements sessions and training with a new developed device (15 therapy sessions in total).

Group Type: EXPERIMENTAL

T-chair

Intervention Type: DEVICE

Participants will receive 15 sessions of intervention, four weeks in total with a duration of one hour for each session. The focus of the intervention will be trunk rehabilitation.

Measurements

This group will receive three measurements sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

T-chair

Participants will receive 15 sessions of intervention, four weeks in total with a duration of one hour for each session. The focus of the intervention will be trunk rehabilitation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. First major stroke event, a transient ischemic attack or a previous stroke with full recovery is allowed.

2. Impairment of the trunk function, with a maximum score of 19 on the trunk impairment scale .

3. Able to maintain seated position for more than 10 seconds.

4. Able to come to the rehabilitation ward as a chronic patient.

5. More than six months after a stroke event.

6. Older than 18 years.

7. With no comorbidities other than stroke affecting trunk function. Comorbidities could be musculoskeletal problems or other neurological diseases.

8. With sufficient cognitive and language capacity to perform the assessment.

Exclusion Criteria

1. Not able to give informed consent.

2. Not approved informed consent.

3. Subject does not understand the study procedures.

4. Subject has any history of another major neurological disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liselot Thijs

Leuven, , Belgium

Countries

Belgium

References

Thijs L, Voets E, Wiskerke E, Nauwelaerts T, Arys Y, Haspeslagh H, Kool J, Bischof P, Bauer C, Lemmens R, Baumgartner D, Verheyden G. Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2021 Jul 28;18(1):120. doi: 10.1186/s12984-021-00910-7.

Reference Type: DERIVED

PMID: 34321042 (View on PubMed)

Related Links

https://doi.org/10.1186/s12984-021-00910-7

Open access

Other Identifiers

T-Chair

Identifier Type: -

Identifier Source: org_study_id