Potential for Recovery of Voluntary Finger Extension After Stroke (PROVES)

May 13, 2026 updated by: University College, London

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Professor Nick Ward, MD
  • Phone Number: +44 20 3448 3486
  • Email: n.ward@ucl.ac.uk

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BJ
        • University College London- Department of Clinical and Movement Neurosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular electrical stimulation (NMES) and home exercise programme
Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 and Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Fugl-Meyer Assessment
Time Frame: Day 1 and Day 90
Measurement of upper limb motor recovery after stroke
Day 1 and Day 90
Hand Dynamometry
Time Frame: Day 1 and Day 90
Measurement of grip strength
Day 1 and Day 90
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.
Day 1 and Day 90
Modified Tardieu Scale (MTS)
Time Frame: Day 1 and Day 90
MTS is a clinical tool used to assess spasticity.
Day 1 and Day 90
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.
Day 1 and Day 90
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.
Day 1 and Day 90
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.
Day 1 and Day 90
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.
Day 1 and Day 90
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).
Day 1 and Day 90
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.
Day 1 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Principal Investigator: Nick Ward, MD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 367119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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