StrokeNCT06296069
Exergames on an Unstable Surface in Stroke Inpatients
A study testing exergame-based cognitive-motor training on an unstable surface and exergame-based cognitive-motor training on an stable surface in people with Stroke, run by Eleftheria Giannouli at 1 site in Switzerland.
Trial summary
Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients. This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- exergame-based cognitive-motor training on an unstable surface and exergame-based cognitive-motor training on an stable surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2024to 17 Sep 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescription for inpatient rehabilitation due to a stroke
- Ability to provide a signed informed consent
- Mini-Mental State Examination (MMSE) score ≥ 20
- Physically able to stand for at least 3 minutes without external support (self-report)
Who cannot join
- Insufficient knowledge of the German language to understand the instructions and the games
- Conservatively treated osteoporotic fractures in the last 16 weeks
- Depending on assistance for ambulation (Functional Ambulation Categories <2),
- Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities which impair the ability to play the exergames and/or conduct the pre-/post assessments
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehaklinik Zihlschlacht
Zihlschlacht-Sitterdorf, Thurgau, 8588
About this study
Official title: Cognitive-motor Training on a Labile Surface in Stroke Inpatients: Feasibility and Preliminary Effects
Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.
Read the detailed description
As a result of the impairment in cognitive and motor functioning after a stroke, the balance ability worsens and gait becomes unsteady. Of all complications following a stroke, falls are one of the most prevalent and the frequency of total fall events is rising with time after the stroke. Since falls are in general the leading reason for injuries in older adults and about a third of persons older than 65 years fall once a year, there is an overall need for interventions.
Balance training is an established form of exercise in people suffering from stroke and other neurological disabilities. However, cognitive-motor training is superior to single physical training in improving motor functioning e.g. gait speed and walking endurance in stroke patients. More specifically, compared to sequential (e.g. cycling followed by cognitive training) and simultaneous-additional (e.g. cycling while solving an arithmetical task), simultaneous-incorporated motor-cognitive training (e.g. any type of training in which the cognitive task is "incorporated" into the motor task, i.e. the cognitive task is a relevant prerequisite to successfully solve the motor-cognitive task) seems to be the most promising training type for improving gait speed and potentially other functions in stroke patients.
Exergames (interactive (cognitive) games which are played by body movements) are an excellent tool for the delivery of simultaneous-incorporated cognitive-motor training and they have already been used in the context of several frail and neurologic populations, including stroke patients.
Proprioception is used to stabilize the body by sensing its position in space via the sense of joint and limb positioning. Proprioception training addresses the balance and somatosensory stimulation and can therefore build a possible prevention strategy for further falls and of managing ADLs. Combining proprioceptive training with simultaneous cognitive tasks could have additional positive outcomes in stroke rehabilitation. Indeed, a recent systematic review concluded that proprioceptive and dual-task exercises stimulate and promote postural balance, gait, and quality of life and reduce the risk of falls in stroke patients compared with traditional rehabilitation programs.
There is currently just one study that has looked into the effects of exergame-based cognitive-motor training with the additional proprioceptive stimulation (by playing the exergames on a labile platform). They found that compared to the training on a stable platform and to a passive control group, training on an instable platform is more effective for the improvement of reactive balance and functional mobility under dual-task conditions in healthy, community-dwelling older adults. The feasibility and effects of this type of training (exergame training on labile surface and thus rich in proprioceptive stimulation) in stroke patients remains unknown.
Therefore, the aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
The investigators hypothesize that exergame-based cognitive-motor on a labile surface will be feasible within the context of inpatient rehabilitation of stroke patients. In addition, the investigators hypothesize that compared to training on stable surface, training on a labile platform will be more effective for the improvement of motor and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.
- Conditions
- Stroke
- Being tested
- exergame-based cognitive-motor training on an unstable surface, exergame-based cognitive-motor training on an stable surface
- Keywords
- exergames, cognitive-motor, proprioception, stroke, motor-cognitive, inpatient rehabilitation, neurologic patients, cognition, balance, gait, technology-based training, exercise, serious games, active video games
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergame-based cognitive-motor training on an unstable surfaceOther
The intervention group will receive an exergame-based cognitive-sensorimotor intervention on an unstable surface (by placing the exergame device (Senso) on an unstable surface).
The Senso is a platform for the dynamic recording of steps, weight shifts and other body movements producing forces. For the labile condition, the Senso is mounted on steel balls, allowing the platform to swing freely along the horizontal plane. There is no movement induced by the platform itself. Sway is only induced when the participant steps and shifts the center of pressure. The degree of instability and movement of the platform can be adjusted by inducing a dampening. The dampening can be set manually, either to on or off. When damping is on, the movement can be reduced by predefined percentages. The maximum displacement of the platform is thereby 100 mm to each side.
exergame-based cognitive-motor training on an stable surfaceOther
The control group will receive an exergame-based cognitive-motor intervention on an stable surface using the exergame device Senso.
The Senso is a platform for the dynamic recording of steps, weight shifts and other body movements producing forces.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will conduct an exergame-based cognitive-motor intervention on a unstable surface (on top of their standard inpatient treatment).
Intervention duration will be tailored to the stay in the inpatient rehabilitation clinic (3-4 weeks). Training sessions will last 20-28 minutes (progressive increase). Receives: Other: exergame-based cognitive-motor training on an unstable surface |
| Control group | Active comparator | The intervention group will conduct an exergame-based cognitive-motor intervention on a stable surface (on top of their standard inpatient treatment).
Intervention duration will be tailored to the stay in the inpatient rehabilitation clinic (3-4 weeks). Training sessions will last 20-28 minutes (progressive increase). Receives: Other: exergame-based cognitive-motor training on an stable surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security incidents
Total number of (Serious) Adverse Events (SAE/AE)
Measured: through study completion, an average of 6 months (over all training sessions)]
Attrition rate
Number of Drop-outs as percentages of patients included in the study
Measured: through study completion, an average of 6 months
Adherence rate
Number of attended training sessions as percentages of total possible training sessions
Measured: through study completion, an average of 6 months (over all training sessions)]
Usability
Usability will be assessed on basis of the validated German version of the System Usability Scale (SUS-DE). The SUS-DE is assessed in week 6 of the exergame-based intervention. It consists of ten items that are rated on a five-point Likert scale (i.e. ranging from 1 - "strongly disagree" to 5 - "strongly agree"). A total score will be calculated according to the scoring guidelines of the SUS. The total SUS score ranges between 0 and 100, whereas higher scores indicate better usability. A total SUS score of at least 70 will be considered an "acceptable" solution (i.e. 52 = ok, 73 = good, 85 = excellent, 100 = best imaginable).
Measured: The System Usability Scale is recorded at the end of the training period and as part of the T2 measurements, through study completion (max. 6 months)
Training Load
The NASA-Task Load Index (TLX) is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload. For this study only the 2 subscales "Mental Demand" and "Physical Demand" will be used.
Measured: The 2 questions of the Nasa-TLX will be asked after each training session, through study completion (about 6 months). Answers will be presented descriptively for each training session as well as aggregated by averaging values across all training sessions
Enjoyment
Enjoyment of the exergame-based intervention concept will be assessed on basis of the Exergame Enjoyment Questionnaire (EEQ) that will be translated to German according to the guidelines for the process of cross-cultural adaptation of self-report measures. It consists of 20 statements corresponding to four categories of questions: (1) immersion, (2) intrinsically rewarding activity, (3) control, and (4) exercise. Each statement will be responded to on a five-point Likert scale (i.e. strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). The EEQ will be analyzed by calculating the average overall score as well as an average score for each category of questions.
Measured: The EEQ is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
User experience
Several questions specifically tailored to this study regarding perceived safety, perceived positive effects, intention to recommend etc. will be used. Most questions will have a 7step Likert Scale answers. However, there will also be two open ended questions asking for any positive/negative feedback and other general remarks by the participants.
Measured: The User Experience questions is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Training Goals
Personal goals regarding rehabilitation/training will be assessed with the Goal Attainment Scale (GAS). The GAS is an individual approach to defining and evaluating personal rehabilitation goals. The scale consists of a five-point rating of the achievement of the specified goals. A score of 0 corresponds to the expected improvement or achievement of the predefined goal. A negative score of -1 or -2 is considered worse than expected. A positive score of 1 and 2 is given when the goal is achieved even better than expected. Interpersonal scores for the three time-points will be evaluated descriptively for each participant separately.
Measured: The GAS will be defined at T1 (baseline) and will be reevaluated in the middle (after 8 trainings) and T2 (post assessments), through study completion (about 6 months)
Secondary outcomes (12)
Changes in cognitive flexibility
Cognitive flexibility will be assessed using the Trail making test (TMT): The TMT is a widely used neuropsychological test only requiring paper and pencil and has two parts, TMT.A and TMT.B. Circled numbers from 1 to 25 are allocated randomly on a sheet which participants have to connect in the right order (TMT.A). At TMT-B, circled numbers and letters are randomly allocated on a sheet and the participants have to connect circled numbers and letters in the right order and in alternating manner. The required time to complete each task as well as the difference between the scores TMT.B-TMT.A measured in both parts will be evaluated.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in psychomotor speed
The Step Reaction Time Test measures psychomotor speed in terms of reaction to visual stimuli using the lower extremities in 6 directions (front right, front left, right, left, back right \& back left). There are six light grey triangles on the screen and each time one of then turns black, participants need to step as quickly as possible in the respective direction. Average reaction time across all stimuli will be used for analyses.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in selective attention
The Go/No-Go test measures selective attention and inhibition. Participants fixate on a small grey dot in the middle of the screen. Crosses (+) and Xs (x) appear on the right and left side of the grey dot in a randomised order. The task is to ignore the + and just conduct a step as quickly as possible in the direction that an (x) appears.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in inhibition and brain activity
The Stroop Test assesses inhibition. A computer-based version of the Stroop Colour-Word will be conducted. Participants are instructed to press a button corresponding to the ink or colour of the ink/color of the word/stimuli that appears on the screen as quickly as possible. Reaction time in ms on response-correct trials and accuracy in % is extracted separately for compatible and incompatible trials. The Stroop Test will be coupled with functional a near-infrared spectroscopy (fNIRS) system (NIRx Medical Technologies, NIRSport2, Berlin, Germany) to assess which brain regions are active during the cognitive test. Outcomes are the average change from baseline concentration of Oxyhaemoglobin (HbO2) and haemoglobin (HHb) with no cognitive task in comparison to conducting a cognitive test (Stroop). Another outcome builds the difference from the peak concentration of HbO2 to the baseline with no cognitive task.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in functional mobility
Functional mobility will be measured using the instrumented version of the Timed Up and Go Test (iTUG). Four inertial sensor units (Opal, APDM, Oregon USA) are attached to the participant's body. At the start signal participants must stand up from a chair, walk 3 meters at a comfortable walking speed, come back and sit down on the chair again. A dual-task condition will also be conducted. In the dual-task condition participants have to count backwards in steps of three from a random given number while they are performing the test. Following outcome measures will be used for further analyses for the single task and the dual-task conditions respectively: total duration, sit-to-stand duration, turn velocity, turn-to-sit velocity. Additionally, relative dual task costs (DTC) of walking as percentage of loss relative to the single-task walking performance, according to the formula DTC [%] = 100 * (single-task score - dual-task score)/single-task score will be calculated.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in coordination
Motor coordination is assessed using the 4 Step Square test (4SST). The 4SST assess a person's ability to step as quickly as possible in all 4 directions: forward, backward and sidewards. At the start, the participant stands in Square 1, facing Square 2 and will step clockwise over every Square until Square 4 and anti- clockwise back to Square 1. Time is measured to complete this task.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in dynamic balance
Dynamic balance is assessed with the Shape Tracking Test. Participants are asked to move their center of pressure (COP) displacement by bending or rotating their body without moving the feet, so that they remain within the track that is shown on the screen.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in static balance
Postural Sway will be assessed with the iSway test of the APDM inertial sensor system. One inertial sensor unit (Opal, APDM, Oregon USA) is attached to the participant's body (lower back) with an elastic strap. Participants are required to stand as still as possible for 30 seconds. Several center of pressure (COP) displacement measures are computed with the Software "Mobility Lab 2®; Oregon", that comes along with the inertial sensor system. Mean displacement velocity and sway area will be used for further analyses.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in gait
Gait Analysis will be conducted with the iWalk test of the APDM inertial sensor system. Four inertial sensor units (Opal, APDM, Oregon USA) (two at the feet, one at the lower back and one on the chest) are attached to the participant's body with elastic straps. Participants are required to walk for 2 minutes. Two trials will be conducted for each participant: on in their preferred walking speed and one in which participants are asked to walk as fast as possible (but without running). Several gait performances metrics are computed with the software "Mobility Lab 2®; Oregon, that comes along with the inertial sensor system. Stride length, stride velocity, and gait variability will be used for further analyses.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in leg proprioception
Leg proprioception will be assessed using the ProMeTo-System. In this test, the examiner will move participants joints into several positions. Participants will be asked to memorize and replicate exactly the position that the examiner specified without visual control. Average angle differences for each joint will be used for further analyses.
Because there are currently no reference values and/or standard error measurement values for this population, this test will be repeated twice before the onset of the intervention (once during the pre-assessment, together with all the rest of the pre-port assessments and once again one day later, just before starting the first training session) in order to calculate its test-retest reliability and assessment error (minimum detectable difference) for this population.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in balance confidence
The German version of the Activity- specific balance confidence scale (ABC-D) will be used to assess balance confidence in various activities in older people. The questionnaire uses a scale from 0 to 100% about the confidence of maintaining balance by activities. In total sixteen questions will be asked, and the total mean scores will be calculated.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in gait confidence
The German version of the Modified gait efficacy scale (mGES-D) will be used to assess perception of confidence in walking under challenging circumstances. It is a 10-item questionnaire on a 10- point Likert scale. 1 means no confidence; 10 means full confidence. 100 points means complete confidence in every task.
Measured: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start28 Feb 2024
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleftheria Giannouli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleftheria Giannouli, Swiss Federal Institute of Technology
- Investigators
- Eleftheria Giannouli, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296069
- Sponsor's protocol ID
- SwingIT-stroke
- Status last verified
- Oct 2024
- First submitted
- 20 Feb 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abbott RD, Curb JD, Rodriguez BL, Masaki KH, Popper JS, Ross GW, Petrovitch H. Age-related changes in risk factor effects on the incidence of thromboembolic and hemorrhagic stroke. J Clin Epidemiol. 2003 May;56(5):479-86. doi: 10.1016/s0895-4356(02)00611-x.
PubMed 12812823Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
PubMed 29791947Chen X, Liu F, Lin S, Yu L, Lin R. Effects of Virtual Reality Rehabilitation Training on Cognitive Function and Activities of Daily Living of Patients With Poststroke Cognitive Impairment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2022 Jul;103(7):1422-1435. doi: 10.1016/j.apmr.2022.03.012. Epub 2022 Apr 10.
PubMed 35417757Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
PubMed 30143002Chiaramonte R, Bonfiglio M, Leonforte P, Coltraro GL, Guerrera CS, Vecchio M. Proprioceptive and Dual-Task Training: The Key of Stroke Rehabilitation, A Systematic Review. J Funct Morphol Kinesiol. 2022 Jul 7;7(3):53. doi: 10.3390/jfmk7030053.
PubMed 35893327Mura G, Carta MG, Sancassiani F, Machado S, Prosperini L. Active exergames to improve cognitive functioning in neurological disabilities: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Jun;54(3):450-462. doi: 10.23736/S1973-9087.17.04680-9. Epub 2017 Oct 25.
PubMed 29072042Wuest S, van de Langenberg R, de Bruin ED. Design considerations for a theory-driven exergame-based rehabilitation program to improve walking of persons with stroke. Eur Rev Aging Phys Act. 2014;11(2):119-129. doi: 10.1007/s11556-013-0136-6. Epub 2013 Dec 7.
PubMed 25309631Jaggi S, Wachter A, Adcock M, de Bruin ED, Moller JC, Marks D, Schweinfurther R, Giannouli E. Feasibility and effects of cognitive-motor exergames on fall risk factors in typical and atypical Parkinson's inpatients: a randomized controlled pilot study. Eur J Med Res. 2023 Jan 16;28(1):30. doi: 10.1186/s40001-022-00963-x.
PubMed 36647177Altorfer P, Adcock M, de Bruin ED, Graf F, Giannouli E. Feasibility of Cognitive-Motor Exergames in Geriatric Inpatient Rehabilitation: A Pilot Randomized Controlled Study. Front Aging Neurosci. 2021 Nov 29;13:739948. doi: 10.3389/fnagi.2021.739948. eCollection 2021.
PubMed 34912206Subramaniam S, Wang S, Bhatt T. Dance-based exergaming on postural stability and kinematics in people with chronic stroke - A preliminary study. Physiother Theory Pract. 2022 Nov;38(13):2714-2726. doi: 10.1080/09593985.2021.1994072. Epub 2021 Dec 2.
PubMed 34852719Morat M, Bakker J, Hammes V, Morat T, Giannouli E, Zijlstra W, Donath L. Effects of stepping exergames under stable versus unstable conditions on balance and strength in healthy community-dwelling older adults: A three-armed randomized controlled trial. Exp Gerontol. 2019 Nov;127:110719. doi: 10.1016/j.exger.2019.110719. Epub 2019 Sep 9.
PubMed 31513877Brooke, J., SUS: A quick and dirty usability scale. Usability Eval. Ind., 1995. 189.
Lohmann, K. and J. Schäffer, System Usability Scale (SUS)-An Improved German Translation of the Questionnaire, 2013. URL https://minds. coremedia. com/2013/09/18/sus-scale-an-improved-german-translation-questionnaire, 2015.
Bangor, A., P. Kortum, and J. Miller, Determining What Individual SUS Scores Mean: Adding an Adjective Rating Scale. J. Usability Stud., 2009. 4: p. 114-123.
Hart, S., Nasa-task load index (Nasa-TLX); 20 years later. Vol. 50. 2006.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-motor Training on a Labile Surface in Stroke Inpatients: Feasibility and Preliminary Effects
- ClinicalTrials.gov ID
- NCT06296069
- Acronym / sponsor ID
- SwingIT-stroke
- Conditions
- Stroke
- Keywords
- exergames, cognitive-motor, proprioception, stroke, motor-cognitive, inpatient rehabilitation, neurologic patients, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eleftheria GiannouliUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 6 Mar 2024 (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.
Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.
Detailed description
As a result of the impairment in cognitive and motor functioning after a stroke, the balance ability worsens and gait becomes unsteady. Of all complications following a stroke, falls are one of the most prevalent and the frequency of total fall events is rising with time after the stroke. Since falls are in general the leading reason for injuries in older adults and about a third of persons older than 65 years fall once a year, there is an overall need for interventions.
Balance training is an established form of exercise in people suffering from stroke and other neurological disabilities. However, cognitive-motor training is superior to single physical training in improving motor functioning e.g. gait speed and walking endurance in stroke patients. More specifically, compared to sequential (e.g. cycling followed by cognitive training) and simultaneous-additional (e.g. cycling while solving an arithmetical task), simultaneous-incorporated motor-cognitive training (e.g. any type of training in which the cognitive task is "incorporated" into the motor task, i.e. the cognitive task is a relevant prerequisite to successfully solve the motor-cognitive task) seems to be the most promising training type for improving gait speed and potentially other functions in stroke patients.
Exergames (interactive (cognitive) games which are played by body movements) are an excellent tool for the delivery of simultaneous-incorporated cognitive-motor training and they have already been used in the context of several frail and neurologic populations, including stroke patients.
Proprioception is used to stabilize the body by sensing its position in space via the sense of joint and limb positioning. Proprioception training addresses the balance and somatosensory stimulation and can therefore build a possible prevention strategy for further falls and of managing ADLs. Combining proprioceptive training with simultaneous cognitive tasks could have additional positive outcomes in stroke rehabilitation. Indeed, a recent systematic review concluded that proprioceptive and dual-task exercises stimulate and promote postural balance, gait, and quality of life and reduce the risk of falls in stroke patients compared with traditional rehabilitation programs.
There is currently just one study that has looked into the effects of exergame-based cognitive-motor training with the additional proprioceptive stimulation (by playing the exergames on a labile platform). They found that compared to the training on a stable platform and to a passive control group, training on an instable platform is more effective for the improvement of reactive balance and functional mobility under dual-task conditions in healthy, community-dwelling older adults. The feasibility and effects of this type of training (exergame training on labile surface and thus rich in proprioceptive stimulation) in stroke patients remains unknown.
Therefore, the aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
The investigators hypothesize that exergame-based cognitive-motor on a labile surface will be feasible within the context of inpatient rehabilitation of stroke patients. In addition, the investigators hypothesize that compared to training on stable surface, training on a labile platform will be more effective for the improvement of motor and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: exergame-based cognitive-motor training on an unstable surfaceThe intervention group will conduct an exergame-based cognitive-motor intervention on a unstable surface (on top of their standard inpatient treatment). Intervention duration will be tailored to the stay in the inpatient rehabilitation clinic (3-4 weeks). Training sessions will last 20-28 minutes (progressive increase). |
| Control group | Active comparator | Other: exergame-based cognitive-motor training on an stable surfaceThe intervention group will conduct an exergame-based cognitive-motor intervention on a stable surface (on top of their standard inpatient treatment). Intervention duration will be tailored to the stay in the inpatient rehabilitation clinic (3-4 weeks). Training sessions will last 20-28 minutes (progressive increase). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prescription for inpatient rehabilitation due to a stroke
- Ability to provide a signed informed consent
- Mini-Mental State Examination (MMSE) score ≥ 20
- Physically able to stand for at least 3 minutes without external support (self-report)
Key exclusion criteria (4 listed)
- Insufficient knowledge of the German language to understand the instructions and the games
- Conservatively treated osteoporotic fractures in the last 16 weeks
- Depending on assistance for ambulation (Functional Ambulation Categories <2),
- Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities which impair the ability to play the exergames and/or conduct the pre-/post assessments
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 |
|---|---|---|
| exergame-based cognitive-motor training on an unstable surfaceThe intervention group will receive an exergame-based cognitive-sensorimotor intervention on an unstable surface (by placing the exergame device (Senso) on an unstable surface). The Senso is a platform for the dynamic recording of steps, weight shifts and other body movements producing forces. For the labile condition, the Senso is mounted on steel balls, allowing the platform to swing freely along the horizontal plane. There is no movement induced by the platform itself. Sway is only induced when the participant steps and shifts the center of pressure. The degree of instability and movement of the platform can be adjusted by inducing a dampening. The dampening can be set manually, either to on or off. When damping is on, the movement can be reduced by predefined percentages. The maximum displacement of the platform is thereby 100 mm to each side. | Other | Intervention group |
| exergame-based cognitive-motor training on an stable surfaceThe control group will receive an exergame-based cognitive-motor intervention on an stable surface using the exergame device Senso. The Senso is a platform for the dynamic recording of steps, weight shifts and other body movements producing forces. | Other | Control group |
Primary outcome
Security incidents
Time frame: through study completion, an average of 6 months (over all training sessions)]
Total number of (Serious) Adverse Events (SAE/AE)
Attrition rate
Time frame: through study completion, an average of 6 months
Number of Drop-outs as percentages of patients included in the study
Adherence rate
Time frame: through study completion, an average of 6 months (over all training sessions)]
Number of attended training sessions as percentages of total possible training sessions
Usability
Time frame: The System Usability Scale is recorded at the end of the training period and as part of the T2 measurements, through study completion (max. 6 months)
Usability will be assessed on basis of the validated German version of the System Usability Scale (SUS-DE). The SUS-DE is assessed in week 6 of the exergame-based intervention. It consists of ten items that are rated on a five-point Likert scale (i.e. ranging from 1 - "strongly disagree" to 5 - "strongly agree"). A total score will be calculated according to the scoring guidelines of the SUS. The total SUS score ranges between 0 and 100, whereas higher scores indicate better usability. A total SUS score of at least 70 will be considered an "acceptable" solution (i.e. 52 = ok, 73 = good, 85 = excellent, 100 = best imaginable).
Training Load
Time frame: The 2 questions of the Nasa-TLX will be asked after each training session, through study completion (about 6 months). Answers will be presented descriptively for each training session as well as aggregated by averaging values across all training sessions
The NASA-Task Load Index (TLX) is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload. For this study only the 2 subscales "Mental Demand" and "Physical Demand" will be used.
Enjoyment
Time frame: The EEQ is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Enjoyment of the exergame-based intervention concept will be assessed on basis of the Exergame Enjoyment Questionnaire (EEQ) that will be translated to German according to the guidelines for the process of cross-cultural adaptation of self-report measures. It consists of 20 statements corresponding to four categories of questions: (1) immersion, (2) intrinsically rewarding activity, (3) control, and (4) exercise. Each statement will be responded to on a five-point Likert scale (i.e. strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). The EEQ will be analyzed by calculating the average overall score as well as an average score for each category of questions.
User experience
Time frame: The User Experience questions is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Several questions specifically tailored to this study regarding perceived safety, perceived positive effects, intention to recommend etc. will be used. Most questions will have a 7step Likert Scale answers. However, there will also be two open ended questions asking for any positive/negative feedback and other general remarks by the participants.
Training Goals
Time frame: The GAS will be defined at T1 (baseline) and will be reevaluated in the middle (after 8 trainings) and T2 (post assessments), through study completion (about 6 months)
Personal goals regarding rehabilitation/training will be assessed with the Goal Attainment Scale (GAS). The GAS is an individual approach to defining and evaluating personal rehabilitation goals. The scale consists of a five-point rating of the achievement of the specified goals. A score of 0 corresponds to the expected improvement or achievement of the predefined goal. A negative score of -1 or -2 is considered worse than expected. A positive score of 1 and 2 is given when the goal is achieved even better than expected. Interpersonal scores for the three time-points will be evaluated descriptively for each participant separately.
12 secondary outcomes
Changes in cognitive flexibility
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in psychomotor speed
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in selective attention
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in inhibition and brain activity
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in functional mobility
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in coordination
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in dynamic balance
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in static balance
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in gait
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in leg proprioception
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in balance confidence
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
Changes in gait confidence
Time frame: Both, the pre- and the post-measurements of all secondary outcome measurements will take place within 2 days prior to starting or after completing the intervention
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 23 Oct 2024.
- Background: PubMed 12812823Abbott RD, Curb JD, Rodriguez BL, Masaki KH, Popper JS, Ross GW, Petrovitch H. Age-related changes in risk factor effects on the incidence of thromboembolic and hemorrhagic stroke. J Clin Epidemiol. 2003 May;56(5):479-86. doi: 10.1016/s0895-4356(02)00611-x.
- Background: PubMed 29791947Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
- Background: PubMed 35417757Chen X, Liu F, Lin S, Yu L, Lin R. Effects of Virtual Reality Rehabilitation Training on Cognitive Function and Activities of Daily Living of Patients With Poststroke Cognitive Impairment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2022 Jul;103(7):1422-1435. doi: 10.1016/j.apmr.2022.03.012. Epub 2022 Apr 10.
- Background: PubMed 30143002Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
- Background: PubMed 35893327Chiaramonte R, Bonfiglio M, Leonforte P, Coltraro GL, Guerrera CS, Vecchio M. Proprioceptive and Dual-Task Training: The Key of Stroke Rehabilitation, A Systematic Review. J Funct Morphol Kinesiol. 2022 Jul 7;7(3):53. doi: 10.3390/jfmk7030053.
- Background: PubMed 29072042Mura G, Carta MG, Sancassiani F, Machado S, Prosperini L. Active exergames to improve cognitive functioning in neurological disabilities: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Jun;54(3):450-462. doi: 10.23736/S1973-9087.17.04680-9. Epub 2017 Oct 25.
- Background: PubMed 25309631Wuest S, van de Langenberg R, de Bruin ED. Design considerations for a theory-driven exergame-based rehabilitation program to improve walking of persons with stroke. Eur Rev Aging Phys Act. 2014;11(2):119-129. doi: 10.1007/s11556-013-0136-6. Epub 2013 Dec 7.
- Background: PubMed 36647177Jaggi S, Wachter A, Adcock M, de Bruin ED, Moller JC, Marks D, Schweinfurther R, Giannouli E. Feasibility and effects of cognitive-motor exergames on fall risk factors in typical and atypical Parkinson's inpatients: a randomized controlled pilot study. Eur J Med Res. 2023 Jan 16;28(1):30. doi: 10.1186/s40001-022-00963-x.
- Background: PubMed 34912206Altorfer P, Adcock M, de Bruin ED, Graf F, Giannouli E. Feasibility of Cognitive-Motor Exergames in Geriatric Inpatient Rehabilitation: A Pilot Randomized Controlled Study. Front Aging Neurosci. 2021 Nov 29;13:739948. doi: 10.3389/fnagi.2021.739948. eCollection 2021.
- Background: PubMed 34852719Subramaniam S, Wang S, Bhatt T. Dance-based exergaming on postural stability and kinematics in people with chronic stroke - A preliminary study. Physiother Theory Pract. 2022 Nov;38(13):2714-2726. doi: 10.1080/09593985.2021.1994072. Epub 2021 Dec 2.
- Background: PubMed 31513877Morat M, Bakker J, Hammes V, Morat T, Giannouli E, Zijlstra W, Donath L. Effects of stepping exergames under stable versus unstable conditions on balance and strength in healthy community-dwelling older adults: A three-armed randomized controlled trial. Exp Gerontol. 2019 Nov;127:110719. doi: 10.1016/j.exger.2019.110719. Epub 2019 Sep 9.
- BackgroundBrooke, J., SUS: A quick and dirty usability scale. Usability Eval. Ind., 1995. 189.
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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.
Eleftheria Giannouli, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exergame-based cognitive-motor training on an unstable surface and exergame-based cognitive-motor training on an stable surface in people with Stroke, run by Eleftheria Giannouli at 1 site in Switzerland.
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 4 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 23 Oct 2024. 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 Switzerland. 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?
Security incidents (time frame: through study completion, an average of 6 months (over all training sessions)]). The study lists 8 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 NCT06296069, which also lists 30 linked publications.
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 23 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.