Potential for Recovery of Voluntary Finger Extension After Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with a Stroke >6 months previously
Medical Research Council (MRC) grade 0 or 1 in long finger extensors.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Neuromuscular Electrical Stimulation and Home Exercise Programme
Behavioral-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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Neuromuscular electrical stimulation (NMES) and home exercise programmeExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day 1 and Day 90Secondary outcomes
1
Upper Extremity Fugl-Meyer Assessment
Measurement of upper limb motor recovery after stroke
Time frame
Day 1 and Day 902
Hand Dynamometry
Measurement of grip strength
Time frame
Day 1 and Day 903
Fugl-Meyer Assessment - Sensory function
As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.
Time frame
Day 1 and Day 904
Modified Tardieu Scale (MTS)
MTS is a clinical tool used to assess spasticity.
Time frame
Day 1 and Day 90Sponsors and contacts
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University College, London
Lead sponsor
University College London Hospitals
Collaborator
National Hospital for Neurology and Neurosurgery, London
Collaborator
Source ClinicalTrials.gov
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