Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000559314
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
21/04/2017
Date last updated
9/07/2021
Date data sharing statement initially provided
26/02/2019
Date results provided
9/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery of movement and sensation after stroke
Scientific title
A single-site observational study of the recovery of voluntary motor activity and somatosensory function after stroke
Secondary ID [1] 291735 0
None
Universal Trial Number (UTN)
U1111-1195-7311
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 302927 0
Condition category
Condition code
Neurological 302407 302407 0 0
Other neurological disorders
Stroke 302420 302420 0 0
Ischaemic
Stroke 302421 302421 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None. This is an observational study with no intervention. Motor and sensory impairment will be evaluated weekly for the first four weeks post-stroke, then fortnightly until performance plateaus or six months post-stroke, whichever occurs first.
Motor assessments include the Fugl-Meyer scale, hand and pinch grip strength, Action Research Arm Test, and walking ability assessed with the Functional Ambulation Category. The Fugl-Meyer scale is a motor impairment assessment which involves performing a number of simple movements and reflexes of the upper and lower limbs. Hand grip and pinch grip tests will involve gripping a small instrument at maximum strength. The Action Research Arm Test evaluates hand and arm function by asking the patient to complete some simple tasks. The Functional Ambulation Category places the patient in one of six categories based on reported walking ability. Sensory assessments include light touch, spatial acuity and proprioception. Light touch involves lightly pressing a thin plastic filament to the base of the thumb and the participant responding when they feel a touch. Similarly, spatial acuity involves lightly pressing two blunt plastic points to the base of the thumb and the participant saying which orientation they are. Proprioception involves one hand being hidden from sight and moved by the experimenter to an angle on a protractor, and the participant is asked to match the angle with the other hand.
Transcranial magnetic stimulation is a noninvasive brain stimulation technique which involves placing a plastic covered coil over the scalp. The coil creates a brief magnetic pulse that excites neurons in the area of the brain controlling movement. This can generate a motor evoked potential (MEP), recorded with surface electromyography. Peripheral nerve stimulation is a noninvasive stimulation technique which involves placing electrodes on the wrist, to activate the underlying ulnar nerve with brief pulses at an intensity 1.5 times perceptual threshold. Sensory processing of this sensation will be detected by using electroencephalography, which involves placing recording electrodes on the scalp to measure the N20 potential.
Magnetic resonance imaging involves the participant lying down in a scanner while it runs for about 30 minutes. We will acquire T1 and diffusion-weighted images, to evaluate the stroke lesion and its effects on white matter integrity. There are no risks associated with any of the motor or sensory assessments. Transcranial magnetic stimulation and peripheral nerve stimulation may cause mild, transient discomfort of the scalp and wrist, respectively. The three neurophysiological techniques have a number of contraindications, which will be screened for prior to inclusion to the study.
Intervention code [1] 297842 0
Not applicable
Comparator / control treatment
None. This is an observational study with no intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301817 0
Proportion of initial upper limb motor impairment recovered at plateau, assessed with the upper extremity Fugl-Meyer scale.
Timepoint [1] 301817 0
Assessed weekly for the first 4 weeks post-stroke, and then fortnightly up to six months post-stroke, in order to determine plateau.
Primary outcome [2] 301825 0
Proportion of initial upper limb cutaneous sensory impairment recovered at plateau, assessed with monofilaments applied to the base of the thumb.
Timepoint [2] 301825 0
Assessed weekly for the first 4 weeks post-stroke, and then fortnightly up to six months post-stroke, in order to determine plateau.
Primary outcome [3] 301826 0
Proportion of initial lower limb motor impairment recovered at plateau, assessed with the lower extremity Fugl-Meyer scale.
Timepoint [3] 301826 0
Assessed weekly for the first 4 weeks post-stroke, and then fortnightly up to six months post-stroke, in order to determine plateau.
Secondary outcome [1] 333971 0
The proportional recovery from upper limb cutaneous sensory impairment, measured with monofilaments, will be compared between patients who have detectable N20 somatosensory evoked potentials in the ipsilesional hemisphere and those who do not.
Timepoint [1] 333971 0
Six months post-stroke
Secondary outcome [2] 333972 0
The time post-stroke at which plateau is reached in the recovery from upper limb cutaneous sensory impairment (measured with monofilaments) and the recovery from upper limb motor impairment (measured with the upper extremity Fugl-Meyer scale) will be compared.
Timepoint [2] 333972 0
Six months post-stroke.

Eligibility
Key inclusion criteria
Aged 18 years or more
Diagnosis of monohemispheric cerebral ischaemic or haemorrhagic stroke within the previous week
Weakness and/or sensory loss on one side of the body as a result of stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cerebellar stroke
Contraindications to non-invasive brain stimulation or MRI
Pre-existing neurological or musculoskeletal condition affecting movement or sensation
Cognitive and/or communication impairment precluding informed consent or compliance with testing procedures.
Life expectancy less than 12 months
Resides out of the Auckland region, precluding follow-up assessments

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The research questions addressed by this study are as follows.
1. Is the recovery of motor and sensory impairment in the upper and lower limb proportional to initial impairment after stroke? This will be addressed with multivariable linear regression modelling of the recovery of motor and sensory impairment with factors initial impairment, age, gender, white matter structural integrity of the motor and sensory tracts, and therapy dose, as per our previous work. This will determine whether there is a proportional relationship between initial impairment and recovery of impairment, for both motor and sensory impairment.

2. Are functionally intact ascending sensory pathways required for recovery (proportional or otherwise) from sensory impairment in the upper limb after stroke? This will be addressed by separately modelling recovery of sensory impairment for patients with and without detectable N20 somatosensory evoked potentials at baseline, with the same factors, to see whether structural integrity of the sensory tracts distinguishes between those patients who experience spontaneous sensory recovery and those who do not.

3. Is there a difference between the time courses of recovery from sensory and motor impairment in the upper limb after stroke? This will be addressed by comparing the times post-stroke when 50% recovery and plateau of motor and sensory upper limb impairment occur. Main effects of test will indicate that the recovery trajectories for sensory and motor impairment systematically differ.

4. Is there a difference between the time courses of recovery from motor impairment in the upper and lower limbs after stroke? This will be addressed by comparing the times post-stroke when 50% recovery and plateau of upper and lower limb motor impairment occur.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
3/10/2017
Date of last participant enrolment
Anticipated
1/06/2021
Actual
5/03/2020
Date of last data collection
Anticipated
1/01/2022
Actual
31/08/2020
Sample size
Target
80
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 8830 0
New Zealand
State/province [1] 8830 0
Auckland

Funding & Sponsors
Funding source category [1] 296231 0
Charities/Societies/Foundations
Name [1] 296231 0
Neurological Foundation of New Zealand
Country [1] 296231 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 295148 0
None
Name [1] 295148 0
Address [1] 295148 0
Country [1] 295148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297470 0
Health and Disability Ethics Committee
Ethics committee address [1] 297470 0
Ethics committee country [1] 297470 0
New Zealand
Date submitted for ethics approval [1] 297470 0
13/04/2017
Approval date [1] 297470 0
31/05/2017
Ethics approval number [1] 297470 0
HDEC approval 17NTB66

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74146 0
Prof Cathy Stinear
Address 74146 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 74146 0
New Zealand
Phone 74146 0
+6499233779
Fax 74146 0
Email 74146 0
[email protected]
Contact person for public queries
Name 74147 0
Cathy Stinear
Address 74147 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 74147 0
New Zealand
Phone 74147 0
+6499233779
Fax 74147 0
Email 74147 0
[email protected]
Contact person for scientific queries
Name 74148 0
Cathy Stinear
Address 74148 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 74148 0
New Zealand
Phone 74148 0
+6499233779
Fax 74148 0
Email 74148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not part of the protocol approved by the ethics committee.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.