Trial · NCT07636538
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | System Usability Scale (SUS) score | at the end of treatment (after 12 sessions) | Usability of the investigational device will be assessed using the System Usability Scale (SUS). Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater perceived usability and therefore a better outcome. |
| Primary | Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Score | At the end of treatment (after 12 sessions) | Participant satisfaction and usability assessment using the QUEST 2.0 questionnaire. Minimum Value: 1 Maximum Value: 5 Interpretation: Higher scores indicate greater user satisfaction with the assistive technology and therefore a better outcome. |
| Primary | Incidence of Adverse Events | Throughout the study period (up to 12 sessions) | Safety assessment based on the frequency of adverse events reported by participants or observed by operators during device use. |
| Primary | State Trait Anxiety Inventory (STAI) score | Baseline and end of treatment | Anxiety associated with device use assessed through self-reported scale, State Trait Anxiety Inventory (STAI). Scale Title: State-Trait Anxiety Inventory (STAI). Minimum Value: 20. Maximum Value: 80. Interpretation: Higher scores indicate greater anxiety and therefore a worse outcome. |
| Primary | Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) Usability Questionnaire Score | At the end of treatment (after 12 sessions) | Usability assessment evaluating the ability of users to safely, effectively, and efficiently interact with the system. Scale Title: Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) - Usability Domain. Minimum Value: 5. Maximum Value: 20. Interpretation: Higher scores indicate better perceived usability of the technology-assisted rehabilitation device and therefore a better outcome. |
| Primary | Perceived Stress Scale (PSS) score | At the end of the treatment (after 12 sessions). | Perceived stress due to the use of the device assessed via Perceived Stress Scale (PSS) score. Scale Title: Perceived Stress Scale (PSS). Minimum Value: 0. Maximum Value: 40. Interpretation: Higher scores indicate greater perceived stress and therefore a worse outcome. |
| Secondary | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score | Baseline and end of treatment (after 12 sessions) | Assessment of upper limb disability and motor function using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scale Title: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater disability and symptoms of the upper extremity and therefore a worse outcome. |
| Secondary | Fugl-Meyer Assessment Score | Baseline and end of treatment (after 12 sessions) | Evaluation of upper limb motor performance using the Fugl-Meyer Assessment. Minimum Value: 0. Maximum Value: 226. Interpretation: Higher scores indicate better sensorimotor function and therefore a better outcome. |
| Secondary | ABILHAND Scale Score | Baseline and end of treatment (after 12 sessions) | Assessment of manual ability in activities of daily living using the ABILHAND scale. Minimum Value: 0 . Maximum Value: Not strictly bounded. Interpretation: Higher scores indicate better perceived manual ability in performing daily activities and therefore a better outcome. |
| Secondary | Action Research Arm Test (ARAT) Score | Baseline and end of treatment (after 12 sessions) | Evaluation of upper limb motor function using the Action Research Arm Test. Scale Title: Action Research Arm Test (ARAT) Minimum Value: 0. Maximum Value: 57. Interpretation: Higher scores indicate better upper limb function and dexterity and therefore a better outcome. |
| Secondary | Modified Ashworth Scale (MAS) Score | Baseline and end of treatment (after 12 sessions) | Assessment of muscle spasticity using the Modified Ashworth Scale. Scale Title: Modified Ashworth Scale (MAS) Minimum Value: 0. Maximum Value: 4. Interpretation: Higher scores indicate increased muscle tone/spasticity and therefore a worse outcome. |
| Secondary | Bradykinesia Scale Score | Baseline and end of treatment (after 12 sessions) | Motor performance assessment using the Bradykinesia Scale for Parkinson's disease. Scale Title: Bradykinesia Scale (specify instrument/version used, e.g., UPDRS-III bradykinesia items or a dedicated bradykinesia rating scale). Minimum Value: 0. Maximum Value: 132. Interpretation: Higher scores indicate greater bradykinesia (slower and more impaired voluntary movement) and therefore a worse outcome. |
| Secondary | EuroQol-5D (EQ-5D) Score | Baseline and end of treatment (after 12 sessions) | Assessment of perceived quality of life using the EuroQol-5D questionnaire. Scale Title: EuroQol 5-Dimension Questionnaire (EQ-5D) Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate better health-related quality of life and therefore a better outcome. |
| Secondary | Psychosocial Impact of Assistive Devices Scale (PIADS) Score | End of treatment (after 12 sessions) | Evaluation of the psychosocial impact of the assistive device on participants' daily life via PIADS score. Scale Title: Psychosocial Impact of Assistive Devices Scale (PIADS) Minimum Value: -3. Maximum Value: +3. Interpretation: Higher scores indicate a more positive psychosocial impact of the assistive device and therefore a better outcome. |
| Secondary | Trail Making Test A score | Baseline and end of treatment (after 12 sessions) | Cognitive performance assessment using the Trail Making Test A. Scale Title: Trail Making Test Part A (TMT-A) Minimum Value: 0 seconds. Maximum Value: No fixed maximum (time to completion in seconds; can be unbounded) Interpretation: Higher scores (longer completion time) indicate worse performance and therefore a worse outcome. |
| Secondary | Stroop Test score | Baseline and end of the treatment (after 12 sessions) | Brain's processing speed, attention control, and cognitive flexibility assessed via Stroop Test score. Scale Title: Stroop Color and Word Test (Stroop Test) Minimum Value: 0. Maximum Value: No fixed maximum (time in seconds; unbounded) Interpretation: Higher scores indicate worse performance, therefore a worse outcome. |
| Secondary | Digit Span Test score | Baseline and end of the treatment (after 12 sessions). | Short-term memory, attention, and working memory capacity assessed via Digit Span score. Scale Title: Digit Span Test Minimum Value: 0 (no correct spans recalled). Maximum Value: 18 total items correct. Interpretation: Higher scores indicate better attention and working memory performance and therefore a better outcome. |
| Secondary | Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score | Baseline and End of the Treatment (after 12 sessions). | Motor performance assessment using Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) for Amyotrophic Lateral Sclerosis. Scale Title: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) Minimum Value: 0. Maximum Value: 48. Interpretation: Higher scores indicate better functional status and therefore a better outcome. |
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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