Trial · NCT07893470
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Finger Strength | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N). |
| Primary | Finger Range of Motion | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%). |
| Primary | Finger Muscle Tone | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Finger muscle tone will be assessed using the AMADEO robotic device by measuring passive resistance during finger movement, expressed in Newtons (N). |
| Primary | Finger Spasticity | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities. |
| Primary | Hand Grip Strength | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg). |
| Primary | Muscle Activation | Immediately before and immediately after each stimulation session, twice weekly for 4 weeks | Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV). |
| Secondary | Muscle Strength | Baseline and end of the 4-week intervention period. | Muscle strength will be assessed using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no muscle contraction) to 5 (normal muscle strength). |
| Secondary | Spasticity | Baseline and end of the 4-week intervention period. | Spasticity will be assessed using the Modified Ashworth Scale (MAS), an ordinal scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), including an intermediate 1+ category. |
| Secondary | Upper Limb Functional Performance | Baseline and end of the 4-week intervention period. | Upper limb functional performance will be assessed using the Van Lieshout Test (VLT), in which individual tasks are scored from 0 (unable to perform the task) to 5 (independent and optimal performance). |
| Secondary | Hand Grip Strength | Baseline and end of the 4-week intervention period. | Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg). |
| Secondary | Finger Strength | Baseline and end of the 4-week intervention period. | Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N). |
| Secondary | Finger Range of Motion | Baseline and end of the 4-week intervention period. | Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%). |
| Secondary | Finger Muscle Tone | Baseline and end of the 4-week intervention period. | Finger muscle tone will be assessed using the AMADEO robotic device by measuring passive resistance during finger movement, expressed in Newtons (N). |
| Secondary | Finger Spasticity | Baseline and end of the 4-week intervention period. | Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities. |
| Secondary | Muscle Activation | Baseline and end of the 4-week intervention period. | Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV). |
| Secondary | Neurological Motor Function | Baseline and end of the 4-week intervention period. | Neurological motor function will be assessed using the motor examination component of the American Spinal Injury Association (ASIA) neurological assessment. |
| Secondary | Somatosensory Evoked Potential Latency | Baseline and end of the 4-week intervention period. | Somatosensory evoked potential (SEP) latency will be measured in milliseconds (ms) to characterize somatosensory pathway conduction. |
| Secondary | Treatment Adherence | Throughout the 4-week intervention period. | Treatment adherence will be assessed by recording the number of transcutaneous spinal cord stimulation sessions completed during the intervention period. |
| Secondary | Adverse Events | Throughout the 4-week intervention period. | Adverse events observed or reported during the study will be recorded, including their nature, severity, duration or outcome, relationship to the device or procedure, and any actions taken. |
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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