Trial · NCT03725982
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Muscular Activity of Erector Spinae Muscle. | Average RMS-value (%MVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition | Root-mean-square (RMS) of the electrical activity of the erector spinae muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a maximal voluntary contraction (%MVE) and averaged over the time period of each experimental condition. |
| Primary | Muscular Activity of Biceps Femoris Muscle. | Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition | Root-mean-square (RMS) of the electrical activity of the biceps femoris muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a reference voluntary contraction (%RVE) and averaged over the time period of each experimental condition. |
| Primary | Posture (Thoracic Kyphosis) | Average thoracic kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition | The posture of the upper spine (thoracic kyphosis) determined using 2D gravimetric position sensors placed on the thoracic vertebrae T1 and lumbar vertebrae L1. The difference value between both sensors reflects the thoracic kyphosis, which was averaged over each experimental condition. |
| Primary | Posture (Lumbar Lordosis) | Average lumbar lordosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition | The posture of the lower spine (lumbar lordosis) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L1 and L5. The difference value between both sensors reflects the lumbar lordosis, which was averaged over each experimental condition. |
| Primary | Posture (Trunk Flexion) | Average trunk flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition | The posture of the trunk determined using a 2D gravimetric position sensor placed on the thoracic vertebrae T10. The flexion angle of the sensor was averaged over each experimental condition. |
| Primary | Posture (Hip Flexion) | Average hip flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition | The posture of the hip (hip flexion) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L5 and the upper leg (femur). The difference value between both sensors reflects the hip flexion, which was averaged over each experimental condition. |
| Primary | Posture (Knee Flexion) | Average knee flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition | The posture of the knee (knee flexion) determined using 2D gravimetric position sensors placed on the upper leg (femur) and lower leg (tibia). The difference value between both sensors reflects the knee flexion, which was averaged over each experimental condition. |
| Primary | Knee Compression Force | Average knee compression force (KCF) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition | The knee compression force (KCF) is calculated using 2D inverse modelling with continuous recordings from 2D gravimetric position sensors (for joint angles) and a force plate (for ground reaction forces). The average knee compression force will be calculated over each experimental condition and summarized for both the left and right knee, since the task is executed in the frontal plane. |
| Secondary | Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles. | Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition. | Root-mean-square (RMS) of the electrical activity of the rectus abdominis, vastus lateralis, gastrocnemius medialis and trapezius descendens muscles using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a refeernce voluntary contraction (%RVE) and averaged over the time period of each experimental condition. |
| Secondary | Rating of Perceived Discomfort (RPD) | Change from baseline (0 min) to directly after (1.5 min) both experimental conditions | Discomfort (RPD) was assessed using an 11-point numeric rating scale (NRS), ranging from 0 (no discomfort at all) to 10 (maximally imaginable discomfort). It was assessed directly before (0 min) and directly after (1.5 min) each experimental condition. The experimental conditions consisted of either static or dynamic tasks, that lasted up to 1.5 minutes. |
| Secondary | Heart Rate | Average heart activity over time period baseline (0 min) to directly after (1.5 min) the experimental condition | Continuous recording electrocardiography allows calculating the heart rate, a parameter reflecting the central stress state of the participant. The average heart rate will be calculated per time period. |
| Secondary | Evaluation of Workload | Directly after the experimental condition during which the exoskeleton was worn (~ 4.5-6.5 min) | The NASA Task Load Index (TLX) of Hart and Staveland (1988) will be used to evaluate workload. This standardized tool contains six dimensions (mental demand, physical demand, temporal demand, own performance, effort, frustration), of which each scale ranges from from 0 (low) to 100 (high). We will include three dimensions of interest, i.e. physical demand, temporal demand, effort, and calculate the unweighted average of the score of these three dimensions (Hoonakker et al. 2011). |
| Secondary | Self-developed Participant Evaluation Questionnaire | Directly after the experiment (~2.5 hours) | This questionnaire will consist of questions about usability and acceptance of the intervention (the Laevo device), stemming from standardized questions from existing questionnaires, including: * the System Usability Scale (SUS): 10 statements about subjective perception of interaction with the Laevo system to be evaluated on a scale ranging from 1 (disagree) to 5 (agree); * the Technology Usage Inventory (TUI): 30 statements on technology-specific and psychological factors with respect to the Laevo to be evaluated on a scale ranging from 1 (not true) to 7 (true); of these 30 questions, the investigators include only 7 statements belonging to the domains 'usability' and 'skepticism'. The questionnaire can only be filled out after the condition within which the technology (here: exoskeleton) was used. That means that results are only provided and, thus, reported from the arm "with exoskeleton". |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03725982/registered