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NCT Number: NCT07592247

Potential for Recovery of Voluntary Finger Extension After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London- Department of Clinical and Movement Neurosciences

London, WC1N 3BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neuromuscular Electrical Stimulation and Home Exercise Programme

Behavioral

-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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Upper Extremity Fugl-Meyer Assessment

    Time frame: Day 1 and Day 90

    Measurement of upper limb motor recovery after stroke

  2. Hand Dynamometry

    Time frame: Day 1 and Day 90

    Measurement of grip strength

  3. Fugl-Meyer Assessment - Sensory function

    Time frame: Day 1 and Day 90

    As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.

  4. Modified Tardieu Scale (MTS)

    Time frame: Day 1 and Day 90

    MTS is a clinical tool used to assess spasticity.

  5. KINARM- Passive Stretch Task

    Time frame: Day 1 and Day 90

    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.

  6. Box and Block Test (BBT)

    Time frame: Day 1 and Day 90

    BBT is a standard assessment to measure manual dexterity and gross motor coordination of the hands.

  7. Stroke Impact Scale (SIS)

    Time frame: Day 1 and Day 90

    SIS is a self-reported questionnaire designed to measure the multidimensional impact of stroke on a person's life.

  8. Neurophysiological- Corticospinal Tract Integrity

    Time frame: Day 1 and Day 90

    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.

  9. Neurophysiological- Reticulospinal Tract Integrity

    Time frame: Day 1 and Day 90

    This will be assessed using the Start React Protocol and measurement of ipsilateral Motor Evoked Potentials (iMEPs).

  10. Neurophysiological- Somatosensory Evoked Potentials

    Time frame: Day 1 and Day 90

    Median nerve somatosensory evoked potentials will be measured using Electroencephalography (EEG). The measures will mainly involve recording cortical responses to peripheral nerve stimulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Tedesco Triccas, PhD

CONTACT

[email protected]

Professor Nick Ward, MD

CONTACT

[email protected]

+44 20 3448 3486

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • National Hospital for Neurology and Neurosurgery, London
  • University College London Hospitals

Registry information

Acronym: PROVES

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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