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

13 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Professor Nick Ward, MD
  • Telefonnummer: +44 20 3448 3486
  • E-post: n.ward@ucl.ac.uk

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Neuromuscular electrical stimulation (NMES) and home exercise programme
Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Voluntary Finger Extension (VFE)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Upper Extremity Fugl-Meyer Assessment
Tidsram: Day 1 and Day 90
Measurement of upper limb motor recovery after stroke
Day 1 and Day 90
Hand Dynamometry
Tidsram: Day 1 and Day 90
Measurement of grip strength
Day 1 and Day 90
Fugl-Meyer Assessment - Sensory function
Tidsram: 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)
Tidsram: Day 1 and Day 90
MTS is a clinical tool used to assess spasticity.
Day 1 and Day 90
KINARM- Passive Stretch Task
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University College, London

Samarbetspartners

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

Utredare

  • Huvudutredare: Nick Ward, MD, University College, London

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 juni 2029

Avslutad studie (Beräknad)

1 september 2029

Studieregistreringsdatum

Först inskickad

24 april 2026

Först inskickad som uppfyllde QC-kriterierna

13 maj 2026

Första postat (Faktisk)

18 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 367119

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