StrokePROVESNCT07592247
Potential for Recovery of Voluntary Finger Extension After Stroke
A study testing Neuromuscular Electrical Stimulation and Home Exercise Programme in people with Stroke, run by University College, London at 1 site in United Kingdom.
Trial summary
Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Neuromuscular Electrical Stimulation and Home Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a Stroke >6 months previously
- Medical Research Council (MRC) grade 0 or 1 in long finger extensors.
Who cannot join
- Presence of spasticity in any wrist/finger flexors (including lumbricals) >2 on Modified Ashworth Scale
- Unable to get hand flat on table top
- Botulinum toxin to long finger or wrist flexors < 24 weeks prior to pre-treatment assessment (i.e. effects should have worn off).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa Tedesco Triccas, PhD contact
United Kingdom1 site
University College London- Department of Clinical and Movement Neurosciences
London, WC1N 3BJ
About this study
Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. In this study, we will identify the characteristics of those chronic stroke patients who regain previously absent VFE.
Hundred chronic stroke patients will be recruited with absent/negligible VFE in an external pilot and feasibility study. Transcranial magnetic stimulation will be used to determine the functional integrity of descending white matter pathways. Corticospinal tract integrity to finger extensor muscles will be based on whether motor-evoked potentials are present (MEP+) or absent (MEP-). Reticulospinal tract activity will be assessed by measuring ipsilateral MEP amplitudes and the Start-React response.
Read more
All patients will then receive 3-months of neuromuscular electrical stimulation plus home exercise, designed to strengthen wrist/finger extensors, reduce spasticity and increase corticospinal excitability. The primary outcome measure will be restoration of VFE.
It is predicted that VFE will be restored in MEP+ but not MEP- patients. MEP- patients will have higher reticulospinal tract activity associated with spasticity. Restoration of VFE will allow patients to engage in evidence-based upper limb training to improve function e.g. constraint induced movement therapy or repetitive task training.
- Conditions
- Stroke
- Being tested
- Neuromuscular Electrical Stimulation and Home Exercise Programme
- Keywords
- Upper limb, Finger extension, Neurophysiological mechanisms, Neurorehabilitation, Motor recovery, functional electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation and Home Exercise ProgrammeBehavioural
-Neuromuscular and Electrical Stimulation (NMES): All participants will undergo a NMES treatment programme designed to strengthen wrist and finger extensors. Participants and their carers will receive training in NMES set up from the research physiotherapist. Surface electrodes are placed over the motor points of extensor carpi radialis and extensor digitorum communis to produce wrist and finger extension simultaneously.
Home exercise: We aim for all patients to perform the Graded Repetitive Arm Supplementary Program (GRASP) level 1 (for severely affected upper limbs) for a minimum of 60 minutes/day, 5 days/week. Patients will be provided with an exercise book containing written and pictorial instructions for each exercise, and the kits contained inexpensive equipment to complete the exercises. Exercises included strengthening of the arm and hand, range of motion, and gross and fine motor skills.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) and home exercise programme | Experimental | Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme Receives: Behavioral: Neuromuscular Electrical Stimulation and Home Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary Finger Extension (VFE)
Can participants achieve at least 10° of thumb abduction/extension, and at least 10° of extension in a minimum of 2 additional digits (movements need to be repeatable 3 times in 1 minute). The extent of VFE will be measured using an electronic goniometer. Extent of finger extension is calculated for each finger as a composite of extension at metacarpophalangeal, proximal and distal interphalangeal joints.
Measured: Day 1 and Day 90
Secondary outcomes (10)
Upper Extremity Fugl-Meyer Assessment
Measurement of upper limb motor recovery after stroke
Measured: Day 1 and Day 90
Hand Dynamometry
Measurement of grip strength
Measured: Day 1 and Day 90
Fugl-Meyer Assessment - Sensory function
As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.
Measured: Day 1 and Day 90
Modified Tardieu Scale (MTS)
MTS is a clinical tool used to assess spasticity.
Measured: Day 1 and Day 90
KINARM- Passive Stretch Task
The KINARM Passive Stretch Task is a quantitative assessment performed with the KINARM robotic assessment system in which the participant's limb is passively displaced by the robot while they are instructed to remain relaxed. The device applies controlled position- or torque-driven perturbations to one or more joints (typically elbow and/or shoulder) across predefined velocities and ranges of motion.
Measured: Day 1 and Day 90
Box and Block Test (BBT)
BBT is a standard assessment to measure manual dexterity and gross motor coordination of the hands.
Measured: Day 1 and Day 90
Stroke Impact Scale (SIS)
SIS is a self-reported questionnaire designed to measure the multidimensional impact of stroke on a person's life.
Measured: Day 1 and Day 90
Neurophysiological- Corticospinal Tract Integrity
Corticospinal tract integrity is measured using Transcranial Magnetic Stimulation (TMS) to evaluate the functional status of motor pathways in the brain and spinal cord - identified as Motor Evoked Potential Positive (MEP+) or Negative (MEP-). Resting and Active Motor Threshold will also be measured in addition with the Compound Muscle Action Potential.
Measured: Day 1 and Day 90
Neurophysiological- Reticulospinal Tract Integrity
This will be assessed using the Start React Protocol and measurement of ipsilateral Motor Evoked Potentials (iMEPs).
Measured: Day 1 and Day 90
Neurophysiological- Somatosensory Evoked Potentials
Median nerve somatosensory evoked potentials will be measured using Electroencephalography (EEG). The measures will mainly involve recording cortical responses to peripheral nerve stimulation.
Measured: Day 1 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, National Hospital for Neurology and Neurosurgery
- Responsible party
- Sponsor
- Investigators
- Nick Ward, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592247
- Sponsor's protocol ID
- 367119
- Acronym
- PROVES
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential for Recovery of Voluntary Finger Extension After Stroke
- ClinicalTrials.gov ID
- NCT07592247
- Acronym / sponsor ID
- PROVES / 367119
- Conditions
- Stroke
- Keywords
- Upper limb, Finger extension, Neurophysiological mechanisms, Neurorehabilitation, Motor recovery, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals, National Hospital for Neurology and Neurosurgery
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. In this study, we will identify the characteristics of those chronic stroke patients who regain previously absent VFE.
Hundred chronic stroke patients will be recruited with absent/negligible VFE in an external pilot and feasibility study. Transcranial magnetic stimulation will be used to determine the functional integrity of descending white matter pathways. Corticospinal tract integrity to finger extensor muscles will be based on whether motor-evoked potentials are present (MEP+) or absent (MEP-). Reticulospinal tract activity will be assessed by measuring ipsilateral MEP amplitudes and the Start-React response.
All patients will then receive 3-months of neuromuscular electrical stimulation plus home exercise, designed to strengthen wrist/finger extensors, reduce spasticity and increase corticospinal excitability. The primary outcome measure will be restoration of VFE.
It is predicted that VFE will be restored in MEP+ but not MEP- patients. MEP- patients will have higher reticulospinal tract activity associated with spasticity. Restoration of VFE will allow patients to engage in evidence-based upper limb training to improve function e.g. constraint induced movement therapy or repetitive task training.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) and home exercise programme | Experimental | Behavioral: Neuromuscular Electrical Stimulation and Home Exercise ProgrammeThree month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with a Stroke >6 months previously
- Medical Research Council (MRC) grade 0 or 1 in long finger extensors.
Key exclusion criteria (3 listed)
- Presence of spasticity in any wrist/finger flexors (including lumbricals) >2 on Modified Ashworth Scale
- Unable to get hand flat on table top
- Botulinum toxin to long finger or wrist flexors < 24 weeks prior to pre-treatment assessment (i.e. effects should have worn off).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical Stimulation and Home Exercise Programme-Neuromuscular and Electrical Stimulation (NMES): All participants will undergo a NMES treatment programme designed to strengthen wrist and finger extensors. Participants and their carers will receive training in NMES set up from the research physiotherapist. Surface electrodes are placed over the motor points of extensor carpi radialis and extensor digitorum communis to produce wrist and finger extension simultaneously. Home exercise: We aim for all patients to perform the Graded Repetitive Arm Supplementary Program (GRASP) level 1 (for severely affected upper limbs) for a minimum of 60 minutes/day, 5 days/week. Patients will be provided with an exercise book containing written and pictorial instructions for each exercise, and the kits contained inexpensive equipment to complete the exercises. Exercises included strengthening of the arm and hand, range of motion, and gross and fine motor skills. | Behavioural | Neuromuscular electrical stimulation (NMES) and home exercise programme |
Primary outcome
Voluntary Finger Extension (VFE)
Time frame: Day 1 and Day 90
Can participants achieve at least 10° of thumb abduction/extension, and at least 10° of extension in a minimum of 2 additional digits (movements need to be repeatable 3 times in 1 minute). The extent of VFE will be measured using an electronic goniometer. Extent of finger extension is calculated for each finger as a composite of extension at metacarpophalangeal, proximal and distal interphalangeal joints.
10 secondary outcomes
Upper Extremity Fugl-Meyer Assessment
Time frame: Day 1 and Day 90
Hand Dynamometry
Time frame: Day 1 and Day 90
Fugl-Meyer Assessment - Sensory function
Time frame: Day 1 and Day 90
Modified Tardieu Scale (MTS)
Time frame: Day 1 and Day 90
KINARM- Passive Stretch Task
Time frame: Day 1 and Day 90
Box and Block Test (BBT)
Time frame: Day 1 and Day 90
Stroke Impact Scale (SIS)
Time frame: Day 1 and Day 90
Neurophysiological- Corticospinal Tract Integrity
Time frame: Day 1 and Day 90
Neurophysiological- Reticulospinal Tract Integrity
Time frame: Day 1 and Day 90
Neurophysiological- Somatosensory Evoked Potentials
Time frame: Day 1 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Tedesco Triccas, PhD contact
Nick Ward, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and Home Exercise Programme in people with Stroke, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Nick Ward, MD (+44 20 3448 3486, n.ward@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary Finger Extension (VFE) (time frame: Day 1 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.