Trial · NCT07887880
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Upper Extremity Fugl-Meyer Scale | 6-9 weeks post-intervention | Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE. |
| Primary | Stroke Impact Scale - Hand Function Score | 6-9 weeks post-intervention | Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function. |
| Primary | Transcranial Magnetic stimulation-induced motor evoked potential | 6-9 weeks post-intervention | Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability. |
| Secondary | Upper Extremity Fugl-Meyer Scale | 12-14 weeks post intervention | Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE. |
| Secondary | Stroke Impact Scale - Hand Function Score | 12-14 weeks post intervention | Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function. |
| Secondary | Transcranial Magnetic stimulation-induced motor evoked potential | 12-14 weeks post intervention | Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability. |
| Other | Grip Strength of the paretic hand | 6-9 weeks Post-intervention | Changes in Grip Strength between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Average grip strength of the of three trials will be reported in kilograms. Higher values indicate better grip strength. |
| Other | Grip Strength of the paretic hand | 12 -14 weeks Post-intervention | Changes in Grip Strength between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Average grip strength of the of three trials will be reported in kilograms. Higher values indicate better grip strength. |
| Other | Upper extremity muscle synergy | 6-9 weeks Post-intervention | Changes in upper extremity muscle synergy between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Transcranial magnetic stimulation induced motor evoked potentials of different proximal and distal upper extremity muscles are coupled using the synergy weights and activation profiles obtained with a novel Principal component-based motor evoked potential analyses. Higher values suggest better muscle synergy. |
| Other | Upper extremity muscle synergy | 12-14 weeks Post-intervention | Changes in upper extremity muscle synergy between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Transcranial magnetic stimulation induced motor evoked potentials of different proximal and distal upper extremity muscles are coupled using the synergy weights and activation profiles obtained with a novel Principal component-based motor evoked potential analyses. Higher values suggest better muscle synergy. |
| Other | Upper Extremity range of motion via kinematics | 6-9 weeks Post-intervention | Changes in Upper Extremity kinematics between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. 3D biomechanical data will be collected using a motion capture system. We will evaluate maximum finger excursions. Higher values indicate greater finger excursion. |
| Other | Upper Extremity range of motion via kinematics | 12-14 weeks Post-intervention | Changes in Upper Extremity kinematics between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. 3D biomechanical data will be collected using a motion capture system. We will evaluate maximum finger excursions. Higher values indicate greater finger excursion. |
| Other | Muscle strength and activation | 6-9 weeks Post-intervention | Changes in muscle strength and activation between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Muscle strength and activation testing will be performed using the triple interpolated twitch technique for the paretic wrist and hand muscles. We will test muscle strength and activation using a customized set-up with load cells for the wrist and hand. Normalized peak force/torque will be used to calculate strength and activation. Higher values indicate greater muscle strength and activation. |
| Other | Muscle strength and activation | 12-14 weeks Post-intervention | Changes in muscle strength and activation between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Muscle strength and activation testing will be performed using the triple interpolated twitch technique for the paretic wrist and hand muscles. We will test muscle strength and activation using a customized set-up with load cells for the wrist and hand. Normalized peak force/torque will be used to calculate strength and activation. Higher values indicate greater muscle strength and activation. |
| Other | Action Research Arm Test | 6-9 weeks Post-intervention | Changes in Action Research Arm Test between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Action Research Arm Test evaluates upper extremity (UE) functional performance using a 4-point ordinal scale on 19-items, which are divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total possible score ranges from 0-57 with higher scores indicating higher UE function. |
| Other | Action Research Arm Test | 12-14 weeks Post-intervention | Changes in Action Research Arm Test between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Action Research Arm Test evaluates upper extremity (UE) functional performance using a 4-point ordinal scale on 19-items, which are divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total possible score ranges from 0-57 with higher scores indicating higher UE function. |
| Other | Social role sub-scale of Assessment of Life Habits | 6-9 weeks Post-intervention | Changes in Social role sub-scale of Assessment of Life Habits between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. The Social-LIFE-H assess the quality of social participation by estimating the perceived difficulty an in-dividual faces in performing a life habit and the type of assistance required to perform it. Using 40 items, the sub-scale assesses restrictions in social responsibilities, interpersonal relationships, community life, education, employment, and leisure. Each item is scored using a 10-point ordinal scale, which ranges from 0-9, where 0 = not able to perform and 9 = able to perform without difficulty with higher scores indicating better social participation. The total possible score will be reported, which is obtained by summing the scores on each item and then dividing by the number of items. |
| Other | Social role sub-scale of Assessment of Life Habits | 12-14 weeks Post-intervention | Changes in Social role sub-scale of Assessment of Life Habits between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. The Social-LIFE-H assess the quality of social participation by estimating the perceived difficulty an in-dividual faces in performing a life habit and the type of assistance required to perform it. Using 40 items, the sub-scale assesses restrictions in social responsibilities, interpersonal relationships, community life, education, employment, and leisure. Each item is scored using a 10-point ordinal scale, which ranges from 0-9, where 0 = not able to perform and 9 = able to perform without difficulty with higher scores indicating better social participation. The total possible score will be reported, which is obtained by summing the scores on each item and then dividing by the number of items. |
| Other | Transcranial magnetic stimulation induced cervicomedullary motor evoked potential | 6-9 weeks Post-intervention | Changes in transcranial magnetic stimulation (TMS) induced cervicomedullary motor evoked potential (CMEP) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. An average peak to peak amplitudes of 20 CMEPs will be reported from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of CMEP indicate greater spinal excitability. |
| Other | Transcranial magnetic stimulation induced cervicomedullary motor evoked potential | 12-14 weeks Post-intervention | Changes in transcranial magnetic stimulation (TMS) induced cervicomedullary motor evoked potential (CMEP) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. An average peak to peak amplitudes of 20 CMEPs will be reported from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of CMEP indicate greater spinal excitability. |
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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