Clinical trial NCT04467554: Providing Sitting Balance Training With a Newly Developed Rehabilitation Device
Official title: Monocenter Interventional Study: Providing Sitting Balance Training With a Newly Developed Rehabilitation Device in the Chronic Stage After Stroke A Feasibility and Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Chronic phase
feasibility
randomized controlled trial
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment
timeFrame: Through study completion, an average of 1.5 months.
measure: Retention
timeFrame: Through study completion, an average of 1.5 months.
measure: Participation
timeFrame: Through study completion, an average of 1.5 months.
measure: Adherence
timeFrame: Through study completion, an average of 1.5 months.
measure: Acceptability and enjoyment
timeFrame: Through study completion, an average of 1.5 months.
measure: Safety and Adverse events
timeFrame: Through study completion, an average of 1.5 months.
measure: Device development or modifications
timeFrame: Through study completion, an average of 1.5 months.
measure: Fatigue
timeFrame: Through study completion, an average of 1.5 months.
measure: Patient Global Impression of Change
timeFrame: Through study completion, an average of 1.5 months.
Secondary outcomes:
measure: Trunk function
timeFrame: Through study completion, an average of 1.5 months.
measure: Trunk stability
timeFrame: Through study completion, an average of 1.5 months.
measure: Trunk strength
timeFrame: Through study completion, an average of 1.5 months.
measure: Sitting balance
timeFrame: Through study completion, an average of 1.5 months.
measure: Walking speed
timeFrame: Through study completion, an average of 1.5 months.
measure: Walking capacity
timeFrame: Through study completion, an average of 1.5 months.
measure: Walking endurance
timeFrame: Through study completion, an average of 1.5 months.
measure: Lower extremities strength
timeFrame: Through study completion, an average of 1.5 months.
measure: Selective movements of the lower extremities and coordination
timeFrame: Through study completion, an average of 1.5 months.
measure: Balance
timeFrame: Through study completion, an average of 1.5 months.
measure: Number of falls
timeFrame: Through study completion, an average of 1.5 months.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Liselot Thijs
Study officials:
References:
citation: 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.