Clinical trial NCT06296069: Exergames on an Unstable Surface in Stroke Inpatients
Official title: Cognitive-motor Training on a Labile Surface in Stroke Inpatients: Feasibility and Preliminary Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: exergames
cognitive-motor
proprioception
stroke
motor-cognitive
inpatient rehabilitation
neurologic patients
cognition
balance
gait
technology-based training
exercise
serious games
active video games
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Security incidents
timeFrame: through study completion, an average of 6 months (over all training sessions)]
measure: Attrition rate
timeFrame: through study completion, an average of 6 months
measure: Adherence rate
timeFrame: through study completion, an average of 6 months (over all training sessions)]
measure: Usability
timeFrame: 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)
measure: Training Load
timeFrame: 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
measure: Enjoyment
timeFrame: The EEQ is recorded at the end of the training period and as part of the T2 measurements, through study completion (about 6 months)
measure: User experience
timeFrame: 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)
measure: Training Goals
timeFrame: 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:
measure: Changes in cognitive flexibility
timeFrame: 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
measure: Changes in psychomotor speed
timeFrame: 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
measure: Changes in selective attention
timeFrame: 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
measure: Changes in inhibition and brain activity
timeFrame: 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
measure: Changes in functional mobility
timeFrame: 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
measure: Changes in coordination
timeFrame: 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
measure: Changes in dynamic balance
timeFrame: 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
measure: Changes in static balance
timeFrame: 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
measure: Changes in gait
timeFrame: 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
measure: Changes in leg proprioception
timeFrame: 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
measure: Changes in balance confidence
timeFrame: 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
measure: Changes in gait confidence
timeFrame: 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
Other outcomes:
Locations:
city: Zihlschlacht-Sitterdorf
country: Switzerland
facility: Rehaklinik Zihlschlacht
state: Thurgau
Study officials:
affiliation: ETH Zurich
name: Eleftheria Giannouli, PhD
role: PRINCIPAL_INVESTIGATOR
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