Trial · NCT06296069
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Security incidents | through study completion, an average of 6 months (over all training sessions)] | Total number of (Serious) Adverse Events (SAE/AE) |
| Primary | Attrition rate | through study completion, an average of 6 months | Number of Drop-outs as percentages of patients included in the study |
| Primary | Adherence rate | through study completion, an average of 6 months (over all training sessions)] | Number of attended training sessions as percentages of total possible training sessions |
| Primary | Usability | 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). |
| Primary | Training Load | 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. |
| Primary | Enjoyment | 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. |
| Primary | User experience | 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. |
| Primary | Training Goals | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Changes in coordination | 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 | 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. |
| Secondary | Changes in dynamic balance | 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 | 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. |
| Secondary | Changes in static balance | 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 | 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. |
| Secondary | Changes in gait | 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 | 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. |
| Secondary | Changes in leg proprioception | 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 | 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. |
| Secondary | Changes in balance confidence | 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 | 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. |
| Secondary | Changes in gait confidence | 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 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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