Trial · NCT03847545
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in GPS. GPS is a summary measure of kinematic data. The GPS evaluates the overall quality of gait by comparing nine kinematic variables, described as Gait Variable Scores (GVS), relative to normative data. GPS is the root mean square (RMS) difference between the data of relevant kinematic variables of an individual patient and the averaged data from a reference group comprised of people without gait impairments. Originally we had registred that we would use the Gait Deviation Index (GDI). GDI is a unitless value from 0 to 100. It is based upon kinematic data and is an overall quantitative index that summarises the overall gait pathology into a single score for each patient by comparison with non-pathological gait. The GDI and GPS is highly correlated. We chose to use the GPS due to the inclusion of the GVS. |
| Secondary | Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in GVS. GVS refers to the Root Mean Square difference between the data of the following kinematic variables of an individual patient and the averaged data from a reference group comprised of people without gait impairments: Pelvic tilt, obliquity and rotation; hip flexion-extension, adduction-abduction, and rotation; knee flexion-extension; ankle dorsiflexion; and foot progression. |
| Secondary | Functional test - 6 Spot Step Test (SSST) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in time it takes the participant to walk through a rectangular area of 1x 5 meters while 5 cylinder blocks must be kicked out of 5 circles marked on the floor. |
| Secondary | Functional test - Timed 25 Footwalk (T25-FW) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in time it takes the participant to walk as safe and as quickly as possible through a straight clearly marked lane of 7.62 meters (25 feet). |
| Secondary | Functional test - 2-minute Walk Test (2MWT) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in distance that the participant is able to walk in 2 minutes. |
| Secondary | Walking speed - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in walking speed (m/s) |
| Secondary | Step length - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in step length (m) |
| Secondary | Step width - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in step width (m) |
| Secondary | Stride length - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in stride length (m) |
| Secondary | Cadence - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in cadence (steps/min.) |
| Secondary | Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in MSWS-12. Data is converted to a scale from 0 to 100, where 0 represents the best and 100 the worst. A change score of at least -4 represents a clinically meaningful improvement in the gait function. |
| Other | Neurological examination - Expanded Disability Status Scale (EDSS) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in EDSS. The scale ranges from 0 to 10, where 0 indicates that the patient is unaffected by the disease, while 10 indicates death by MS. |
| Other | Neurological examination - Multiple Sclerosis Impairment Scale (MSIS) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in MSIS. Normal examination corresponds to the value 0 and the theoretical maximum score is 204. |
| Other | Functional test - Nine Hole Peg Test (9HPT) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in time it takes the participant to collect 9 sticks individually by hand and put them in 9 holes and then to remove them again. The test is performed with each hand. |
| Other | Peak range of motion (kinematic) - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (follow-up from baseline), 52 weeks (follow-up from "baseline" and "14 days") | Change in peak range of motion (degrees) for ankle, knee and hip in sagittal, frontal and transverse plane. Measures are captured during a 3D Vicon gait analysis. |
| Other | Peak and mean joint moments (kinetic) - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in peak and mean joint moments (Nm · BW-1) for ankle, knee and hip in sagittal, frontal and transverse plane. Measures are captured during a 3D Vicon gait analysis. relevant kinetic measures using a 3D Vicon motion capture analysis. |
| Other | Single support - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in single support (percentage of stride) |
| Other | Single Limp Index - (subgroup of 30 allocated to 3D gait analysis) | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change Limp Index (left vs. right in %) |
| Other | Questionnaire - Oxford Shoulder Score (OSS), Danish version | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in OSS. Symptoms are rated between 1 (minimal symptoms) and 5 (severe symptoms). The total score of the 12 questions combined is minimum 12 and maximum 60. |
| Other | Questionnaire - UCLA Activity Scale, Danish version | Baseline, 14 days (Change from baseline to 14 days follow-up) | Change in the University of California Los Angeles activity-level rating (UCLA activity scale), Danish version. On a 10-point scale, the option is marked that matches the level of intensity and frequency of physical activity best, where 1 ="Wholly inactive: depend on others, cannot leave residence, and 10 =" Regularly participates in impact sports". |
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/NCT03847545/registered