Exergames on an Unstable Surface in Stroke Inpatients

Stroke Clinical Trial

Official title:

Cognitive-motor Training on a Labile Surface in Stroke Inpatients: Feasibility and Preliminary Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296069
• Other study ID #: SwingIT-stroke
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Swiss Federal Institute of Technology
• Contact: Eleftheria Giannouli, PhD
• Phone: +41 44 633 90 58
• Email: eleftheria.giannouli[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• exergame-based cognitive-motor training on an unstable surface
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 surface
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.

Locations

Country	Name	City	State
Switzerland	Rehaklinik Zihlschlacht	Zihlschlacht-Sitterdorf	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Eleftheria Giannouli

Country where clinical trial is conducted

Switzerland, 

References & Publications (29)

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Morat 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. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Security incidents	Total number of (Serious) Adverse Events (SAE/AE)	through study completion, an average of 6 months (over all training sessions)]
Primary	Attrition rate	Number of Drop-outs as percentages of patients included in the study	through study completion, an average of 6 months
Primary	Adherence rate	Number of attended training sessions as percentages of total possible training sessions	through study completion, an average of 6 months (over all training sessions)]
Primary	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).	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)
Primary	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.	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
Primary	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.	The EEQ is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
Primary	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.	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)
Primary	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.	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	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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