NCT07592247

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

April 24, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Upper limbFinger extensionNeurophysiological mechanismsNeurorehabilitationMotor recoveryfunctional electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Voluntary Finger Extension (VFE)

    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 Outcomes (10)

  • Upper Extremity Fugl-Meyer Assessment

    Day 1 and Day 90

  • Hand Dynamometry

    Day 1 and Day 90

  • Fugl-Meyer Assessment - Sensory function

    Day 1 and Day 90

  • Modified Tardieu Scale (MTS)

    Day 1 and Day 90

  • KINARM- Passive Stretch Task

    Day 1 and Day 90

  • +5 more secondary outcomes

Study Arms (1)

Neuromuscular electrical stimulation (NMES) and home exercise programme

EXPERIMENTAL

Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme

Behavioral: Neuromuscular Electrical Stimulation and Home Exercise Programme

Interventions

-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.

Neuromuscular electrical stimulation (NMES) and home exercise programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with a Stroke \>6 months previously
  • Medical Research Council (MRC) grade 0 or 1 in long finger extensors.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London- Department of Clinical and Movement Neurosciences

London, WC1N 3BJ, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nick Ward, MD

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Nick Ward, MD

CONTACT

Lisa Tedesco Triccas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 18, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations