StrokeT-ChairNCT04467554
Providing Sitting Balance Training With a Newly Developed Rehabilitation Device
A study testing T-chair in people with Stroke, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Stroke
- What is being tested?
- T-chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jul 2020to 13 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First major stroke event, a transient ischemic attack or a previous stroke with full recovery is allowed.
- Impairment of the trunk function, with a maximum score of 19 on the trunk impairment scale .
- Able to maintain seated position for more than 10 seconds.
- Able to come to the rehabilitation ward as a chronic patient.
- More than six months after a stroke event.
- Older than 18 years.
- With no comorbidities other than stroke affecting trunk function. Comorbidities could be musculoskeletal problems or other neurological diseases.
- With sufficient cognitive and language capacity to perform the assessment.
Who cannot join
- Not able to give informed consent.
- Not approved informed consent.
- Subject does not understand the study procedures.
- Subject has any history of another major neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- The T-chair is a safe and feasible training device, to train trunk function in the subacute and chronic phase after stroke.
- Training on the T-chair has a positive effect on trunk function and strength compared to conventional therapy.
- 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
- Being tested
- T-chair
- Keywords
- Stroke, Rehabilitation, Chronic phase, feasibility, randomized controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-chairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Measurements and T-chair training | Experimental | This group will receive three measurements sessions and training with a new developed device (15 therapy sessions in total). Receives: Device: T-chair |
| Measurements | No intervention | This group will receive three measurements sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment is characterized by the number of possible participants divided by the number of participants actually participated in the trial.
Measured: Through study completion, an average of 1.5 months.
Retention
Retention is the number of participants that complete the whole trial divided by the number of participants that are included in the study.
Measured: Through study completion, an average of 1.5 months.
Participation
During each therapy the therapist evaluates the participation of each candidate.
Measured: Through study completion, an average of 1.5 months.
Adherence
After each therapy session the therapist evaluates the adherence using the Clinician Rating of Compliance Scale. This is a seven point ordinal scale which assesses the level of adherence of the patient. A higher score represent better adherence. A score lower than five is defined as non-adherent.
Measured: Through study completion, an average of 1.5 months.
Acceptability and enjoyment
The level of enjoyment during the training will be assessed using the physical activity enjoyment scale. This scale contains 18 items, during the training participants have to score how they feel about the training on a seven-point bipolar scale. The lowest score stands for less enjoyment or acceptance, a higher score stands for maximum enjoyment or acceptance.
Measured: Through study completion, an average of 1.5 months.
Safety and Adverse events
Safety is evaluated by retaining all adverse events during the therapy sessions.
Measured: Through study completion, an average of 1.5 months.
Device development or modifications
Feedback from the participants and therapists to improve the device are noted after every session. Each patient and therapist who came in contact with the device received an experience questionnaire. The questionnaire contains 16 questions, 3 questions and 13 categorical questions on 5 or 7 point Likert scale.
Measured: Through study completion, an average of 1.5 months.
Fatigue
After each training session fatigue will be evaluated using Visual Analog Fatigue Scale.This scale consists of a 10 cm horizontal line with written description at each end of the line. The written description varies from no fatigue to Very Severe Fatigue on top of the 10 cm line.
Measured: Through study completion, an average of 1.5 months.
Patient Global Impression of Change
The patient Global impression of change is a one single question to rate their condition after the therapy sessions compared to the rate of their condition at the start of the therapy session. This scale will be evaluated twice. One time after two weeks of intervention and once after the four weeks of intervention.
Measured: Through study completion, an average of 1.5 months.
Secondary outcomes (11)
Trunk function
The trunk impairment scale evaluates static and dynamic sitting balance and trunk coordination. The trunk impairment scale scores the trunk function based on 17 items on an ordinal scale. A higher score indicates a better trunk function. The maximum score on this scale is 23 points.
Measured: Through study completion, an average of 1.5 months.
Trunk stability
This will be done by performing the modified functional reaching task. More distance is a better outcome.
Measured: Through study completion, an average of 1.5 months.
Trunk strength
We measure strength in Newton with a hand-held dynamometer (MicroFet 2) of a variety of trunk muscle groups. A higher values stands for a better outcome.
Measured: Through study completion, an average of 1.5 months.
Sitting balance
The limits of stability will be evaluated using the balance platform BioRescue or similar measurement.
Measured: Through study completion, an average of 1.5 months.
Walking speed
Walking at comfortable speed and at maximum speed. Each condition will be performed three times. Patient safety will be guaranteed by a therapist walking next to the patient. Walking speed will also be registered using the GAITRite, which is a CE-marked rehabilitation device.
Measured: Through study completion, an average of 1.5 months.
Walking capacity
The functional ambulation categories examines the level of walking capacity. This test is a six-point scale. It ranges from non-functional walking to walking independently on an unstable surface. At first, we evaluate in this test if the participant is able to walk with or without aid or supervision of two or one therapists. If this is possible, then the assessor evaluates if walking is possible only on an even (indoor) or uneven (outdoor) surface. In this test, the participants will be allowed to use a walking aid. A higher level stands for better walking abilities.
Measured: Through study completion, an average of 1.5 months.
Walking endurance
We evaluate the endurance of walking by using the two-minute walk test (2MWT). The participants walk for two minutes at a standardized indoor walking track and may use a walking aid.
Measured: Through study completion, an average of 1.5 months.
Lower extremities strength
We measure strength in Newton with a hand-held dynamometer (MicroFet 2) of a variety of lower limb muscle groups.
Measured: Through study completion, an average of 1.5 months.
Selective movements of the lower extremities and coordination
We utilize the Fugl-Meyer assessment scale to evaluate selective movements of both the lower extremities.The motor score for the extremities includes assessment of reflex reactions, coordination as well as movements of the shoulder, elbow, wrist, hip, knee and ankle joint. The scoring ranges from 0-34 for selective movements and coordination of the lower extremities and 66 for selective movements and coordination of the upper extremities. A higher score represents a better motor function. We collect the total score and sub scores.
Measured: Through study completion, an average of 1.5 months.
Balance
The Berg Balance scale scores sitting and standing balance based on 14 items. The score ranges from 0 to 56. For each item, the scoring is possible on a 4-point ordinal scale. A higher score represents a better outcome.
Measured: Through study completion, an average of 1.5 months.
Number of falls
Participants in this study all receive an agenda to note the number of falls and the circumstances of the falls. During the four study weeks they have to fill in the agenda when a fall or an almost fall incident occurs.
Measured: Through study completion, an average of 1.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start17 Jul 2020
- Primary completion18 Dec 2020
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467554
- Sponsor's protocol ID
- T-Chair
- Acronym
- T-Chair
- Status last verified
- Jan 2022
- First submitted
- 29 Jun 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34321042
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04467554
- Acronym / sponsor ID
- T-Chair / T-Chair
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Chronic phase, feasibility, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The T-chair is a safe and feasible training device, to train trunk function in the subacute and chronic phase after stroke.
- Training on the T-chair has a positive effect on trunk function and strength compared to conventional therapy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Measurements and T-chair training | Experimental | Device: T-chairThis group will receive three measurements sessions and training with a new developed device (15 therapy sessions in total). |
| Measurements | No intervention | –This group will receive three measurements sessions. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- First major stroke event, a transient ischemic attack or a previous stroke with full recovery is allowed.
- Impairment of the trunk function, with a maximum score of 19 on the trunk impairment scale .
- Able to maintain seated position for more than 10 seconds.
- Able to come to the rehabilitation ward as a chronic patient.
- More than six months after a stroke event.
Key exclusion criteria (4 listed)
- Not able to give informed consent.
- Not approved informed consent.
- Subject does not understand the study procedures.
- Subject has any history of another major neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-chairParticipants 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. | Device | Measurements and T-chair training |
Primary outcome
Recruitment
Time frame: Through study completion, an average of 1.5 months.
Recruitment is characterized by the number of possible participants divided by the number of participants actually participated in the trial.
Retention
Time frame: Through study completion, an average of 1.5 months.
Retention is the number of participants that complete the whole trial divided by the number of participants that are included in the study.
Participation
Time frame: Through study completion, an average of 1.5 months.
During each therapy the therapist evaluates the participation of each candidate.
Adherence
Time frame: Through study completion, an average of 1.5 months.
After each therapy session the therapist evaluates the adherence using the Clinician Rating of Compliance Scale. This is a seven point ordinal scale which assesses the level of adherence of the patient. A higher score represent better adherence. A score lower than five is defined as non-adherent.
Acceptability and enjoyment
Time frame: Through study completion, an average of 1.5 months.
The level of enjoyment during the training will be assessed using the physical activity enjoyment scale. This scale contains 18 items, during the training participants have to score how they feel about the training on a seven-point bipolar scale. The lowest score stands for less enjoyment or acceptance, a higher score stands for maximum enjoyment or acceptance.
Safety and Adverse events
Time frame: Through study completion, an average of 1.5 months.
Safety is evaluated by retaining all adverse events during the therapy sessions.
Device development or modifications
Time frame: Through study completion, an average of 1.5 months.
Feedback from the participants and therapists to improve the device are noted after every session. Each patient and therapist who came in contact with the device received an experience questionnaire. The questionnaire contains 16 questions, 3 questions and 13 categorical questions on 5 or 7 point Likert scale.
Fatigue
Time frame: Through study completion, an average of 1.5 months.
After each training session fatigue will be evaluated using Visual Analog Fatigue Scale.This scale consists of a 10 cm horizontal line with written description at each end of the line. The written description varies from no fatigue to Very Severe Fatigue on top of the 10 cm line.
Patient Global Impression of Change
Time frame: Through study completion, an average of 1.5 months.
The patient Global impression of change is a one single question to rate their condition after the therapy sessions compared to the rate of their condition at the start of the therapy session. This scale will be evaluated twice. One time after two weeks of intervention and once after the four weeks of intervention.
11 secondary outcomes
Trunk function
Time frame: Through study completion, an average of 1.5 months.
Trunk stability
Time frame: Through study completion, an average of 1.5 months.
Trunk strength
Time frame: Through study completion, an average of 1.5 months.
Sitting balance
Time frame: Through study completion, an average of 1.5 months.
Walking speed
Time frame: Through study completion, an average of 1.5 months.
Walking capacity
Time frame: Through study completion, an average of 1.5 months.
Walking endurance
Time frame: Through study completion, an average of 1.5 months.
Lower extremities strength
Time frame: Through study completion, an average of 1.5 months.
Selective movements of the lower extremities and coordination
Time frame: Through study completion, an average of 1.5 months.
Balance
Time frame: Through study completion, an average of 1.5 months.
Number of falls
Time frame: Through study completion, an average of 1.5 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 34321042Thijs 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.
- Open accessLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-chair in people with Stroke, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Through study completion, an average of 1.5 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.