Exergames on an Unstable Surface in Stroke Inpatients

NCT06296069 | Completed

• 1 other identifier: SwingIT-stroke
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Security incidents

  Total number of (Serious) Adverse Events (SAE/AE)

  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

  through study completion, an average of 6 months

• 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)]

• 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)

• 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

• 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)

• 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)

• 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 Outcomes (12)

• Changes in cognitive flexibility

  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

  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

  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

  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

  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

Study Arms (2)

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).

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).

Other: exergame-based cognitive-motor training on an stable surface

Interventions

exergame-based cognitive-motor training on an unstable surface OTHER

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.

Intervention group

exergame-based cognitive-motor training on an stable surface OTHER

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.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleftheria Giannouli: lead

Study Sites (1)

Rehaklinik Zihlschlacht

Zihlschlacht-Sitterdorf, Thurgau, 8588, Switzerland

Location

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MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Eleftheria Giannouli, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 6, 2024
• Study Start: February 28, 2024
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CH (1)