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Potential for Recovery of Voluntary Finger Extension After Stroke

Potential for Recovery of Voluntary Finger Extension After Stroke

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07592247
Acronym
PROVES
Enrollment
100
Registered
2026-05-18
Start date
2026-09-01
Completion date
2029-09-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Upper limb, Finger extension, Neurophysiological mechanisms, Neurorehabilitation, Motor recovery, functional electrical stimulation

Brief 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. 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.

Interventions

BEHAVIORALNeuromuscular 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.

Sponsors

University College, London
Lead SponsorOTHER
University College London Hospitals
CollaboratorOTHER
National Hospital for Neurology and Neurosurgery, London
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with a Stroke \>6 months previously * Medical Research Council (MRC) grade 0 or 1 in long finger extensors.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Voluntary Finger Extension (VFE)Day 1 and Day 90Can 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.

Secondary

MeasureTime frameDescription
Upper Extremity Fugl-Meyer AssessmentDay 1 and Day 90Measurement of upper limb motor recovery after stroke
Hand DynamometryDay 1 and Day 90Measurement of grip strength
Fugl-Meyer Assessment - Sensory functionDay 1 and Day 90As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.
Modified Tardieu Scale (MTS)Day 1 and Day 90MTS is a clinical tool used to assess spasticity.
KINARM- Passive Stretch TaskDay 1 and Day 90The 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.
Box and Block Test (BBT)Day 1 and Day 90BBT is a standard assessment to measure manual dexterity and gross motor coordination of the hands.
Stroke Impact Scale (SIS)Day 1 and Day 90SIS is a self-reported questionnaire designed to measure the multidimensional impact of stroke on a person's life.
Neurophysiological- Corticospinal Tract IntegrityDay 1 and Day 90Corticospinal 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.
Neurophysiological- Reticulospinal Tract IntegrityDay 1 and Day 90This will be assessed using the Start React Protocol and measurement of ipsilateral Motor Evoked Potentials (iMEPs).
Neurophysiological- Somatosensory Evoked PotentialsDay 1 and Day 90Median nerve somatosensory evoked potentials will be measured using Electroencephalography (EEG). The measures will mainly involve recording cortical responses to peripheral nerve stimulation.

Countries

United Kingdom

Contacts

CONTACTProfessor Nick Ward, MD
n.ward@ucl.ac.uk+44 20 3448 3486
CONTACTLisa Tedesco Triccas, PhD
l.triccas@ucl.ac.uk
PRINCIPAL_INVESTIGATORNick Ward, MD

University College, London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026