Trial · NCT07901855
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Eye-Hand Coordination Assessed Using the Rapid Assessment of Eye-Hand Coordination Test | Baseline (before the intervention) and Day 11 (after completion of the 10-day intervention programme). | Eye-hand coordination is assessed using finger-to-nose, finger-to-knee, and finger-chase tasks, with five trials per testing condition. Each upper limb is assessed separately.. Recorded measures include completion time in seconds, movement speed and coordination categories, reaching accuracy, and error type |
| Primary | Change in Fugl-Meyer Assessment of Upper Extremity Function (FMA-UE) scores. | Baseline and day 11 | Change from baseline to Day 11 in upper extremity motor function assessed using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score. The assessment covers arm movements, wrist and hand function, coordination, sensation, passive joint motion, joint pain. Scores range from 0 to 126 points per assessed upper limb, with higher scores indicating better motor function. |
| Primary | Changes in Motor Assessment Scale Upper Limb (UL-MAS). Time frame: Baseline and day 11 | Baseline and day 11 | Upper limb motor function assessed using the three upper limb sections of the Motor Assessment Scale: upper arm function, hand movements, and advanced hand activities (items 6-8). Each section is scored from 0 to 6, giving a total score from 0 to 18 points per assessed upper limb. |
| Primary | Changes in Box and Block Test scores | Baseline (Before the intervention) and day 11 (After completion of the 10-day intervention) | The Box and Block Test assesses unilateral gross manual dexterity. Participants transfer blocks one at a time over a partition between two compartments of a box for 60 seconds. Multiple blocks carried at the same time count as a single block. Each hand is assessed seperately. The score is the number of blocks successfully transferred within the 60 sec, with a minimum of 0 blocks and a maximum of 150. Higher scores indicate better gross manual dexterity. Change is calculated, for each hand, as the difference of score between day 11 and baseline score. |
| Primary | Changes in Motor-FreeVisualPerceptionTEST-4 (MVPT-4) scores | Baseline (before the intervention) and day 11 (after completion of the 10-day programme) | The Motor-Free Visual Perception Test (MVPT-4) is a performance based measure comprised of 45 items presented on separated cards in one spiral bound book. The test assesses domains of visual discrimination, spatial relationships, visual memory, figure ground perception and visual closure. Answers are presented on a multiple choice format with no motor ability needed. Higher scores indicating better visuo-perceptual skills. Administration and scoring following the test manual. |
| Secondary | Changes in Suitability Evaluation Questionnaire (SEQ) | Day 11, after completion of the 10-day virtual reality intervention programme. | Participants in the virtual reality group complete the Suitability Evaluation Questionnaire (SEQ) after the intervention programme. Thirteen items are rated seperately from 1 to 5 and a 14th which is an open ended question. For items 1-11 scores answers range from 1 (not at all) to 5 (very much). Higher scores on 1-6 and 11 show greater enjoyment, presence, perceived performance, realism, clarity of instructions and perceived rehabilitation benefit. For items 7- 10 higher scores show greater discomfort, dizziness/nausea, eye discomfort and disorientation. For items 12 and 13 answers range from 1 (very easy) to 5 (very) difficult with higher scores indicating more difficulty of the application and device. Item 14 asks if participants felt comfortable during the vr sessions (yes/no) and if the answer is no, participants asked to explain the reasons. |
| Secondary | Changes in handgrip strength using the Jamar hydraulic hand dynamometer | Baseline and day 11 | Grip strength is recorded in kilograms (kg) for each tested hand. Higher values indicate greater grip strength |
| Secondary | Changes in Oxford Muscle Scale | Baseline and day 11 | Each tested muscle group is graded from 0 (no contraction) to 5 (normal muscle strength) |
| Secondary | Changes in Motricity Index Upper Extremity score | Baseline and day 11 | The assessment includes pinch grip, elbow flexion, and shoulder abduction. Each component is assigned a score from 0 to 33. The three component scores are summed and one point is added, giving a total score from 1 to 100 for each upper limb. |
| Secondary | Changes in Medical Research Council (MRC) Manual Muscle Testing Scale | Baseline and day 11 | Six muscle groups are tested bilaterally: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors. Each is graded from 0 (no contraction) to 5 (normal muscle strength), giving a total score from 0 to 60 |
| Secondary | Changes in Heart Rate during VR sessions | Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session. | Heart rate is measured in beats per minute in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the heart rate compared to the pre-session value. |
| Secondary | Changes in Systolic blood pressure during VR sessions | Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session. | Systolic blood pressure is measured in millimeters of mercury (mmHg) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the systolic blood pressure compared to the pre-session value. |
| Secondary | Changes in Diastolic blood pressure during VR sessions | Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session. | Diastolic blood pressure is measured in millimeters of mercury (mmHg) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the Diastolic blood pressure compared to the pre-session value. |
| Secondary | Changes in Peripheral Oxygen saturation (SpO2) during VR sessions | Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session. | Changes in Peripheral Oxygen saturation (SpO2) is measured as a percentage (%) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the SpO2 compared to the pre-session value. |
| Secondary | Functional Independence Assessed Using the Barthel Index at Three Months | Three months after completion of the intervention | Functional independence in activities of daily living is assessed using the Barthel Index three months after completion of the intervention programme. The index assesses ten activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility, and stair use. Total scores range from 0 to 100 |
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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