Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

13. mai 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Neuromuscular electrical stimulation (NMES) and home exercise programme
Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Voluntary Finger Extension (VFE)
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College, London

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 367119

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere