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Not yet recruiting NCT07592247

Potential for Recovery of Voluntary Finger Extension After Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuromuscular Electrical Stimulation and Home Exercise Programme.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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 Ar

Primary outcome measures

  • Voluntary Finger Extension (VFE) [Time frame: Day 1 and Day 90]
Secondary outcome measures (10)
  • Upper Extremity Fugl-Meyer Assessment [Time frame: Day 1 and Day 90]
  • Hand Dynamometry [Time frame: Day 1 and Day 90]
  • Fugl-Meyer Assessment - Sensory function [Time frame: Day 1 and Day 90]
  • Modified Tardieu Scale (MTS) [Time frame: Day 1 and Day 90]
  • KINARM- Passive Stretch Task [Time frame: Day 1 and Day 90]
  • Box and Block Test (BBT) [Time frame: Day 1 and Day 90]
  • Stroke Impact Scale (SIS) [Time frame: Day 1 and Day 90]
  • Neurophysiological- Corticospinal Tract Integrity [Time frame: Day 1 and Day 90]
  • Neurophysiological- Reticulospinal Tract Integrity [Time frame: Day 1 and Day 90]
  • Neurophysiological- Somatosensory Evoked Potentials [Time frame: Day 1 and Day 90]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United Kingdom · 1 center
  • University College London- Department of Clinical and Movement Neurosciences — London

Identifiers

NCT: NCT07592247 · 367119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗