StrokeESCAPSNCT02324634
Early Electrical Stimulation to Prevent Complications in the Arm Post-stroke - a Feasibility Study
A study testing NeuroTrac Rehab dual channel device in people with Stroke, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function, muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly half of all stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- NeuroTrac Rehab dual channel device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb
- Patients aged 18 years or over
- Impaired arm movement and strength resulting in reduced function, caused specifically by the stroke. (as determined by the arm subsection score of the National Institute for Health Stroke Scale (NIHSS)
- Nominated carer for a patient participating in the feasibility RCT
- Patients or carers who are participating in the main feasibility RCT
- mental capacity to consent and take part in the interview
Show all 10Show fewer
- Able to understand English
- HCPC registered occupational therapist or physiotherapist
- Currently employed by NUH NHS Trust and working on the Nottingham Stroke Unit
- Experience of supporting at least one participant to use the ES intervention
Who cannot join
- Patients with a previous history of stroke affecting their upper limb will be excluded as a chronic limb condition from a previous stroke could affect the results
- Patients will also be excluded with peripheral nerve injury of the upper limb; an existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy.
- Patients with a cardiac pacemaker or similar implanted device.
- Pregnancy
- Epilepsy
- Undiagnosed pain or skin conditions (i.e. not related to the stroke)
Show all 13Show fewer
- Carer participants for the main feasibility RCT eligibility criteria:
- Non English speaking
- Patient and carer interviews eligibility criteria:
- Unable to communicate verbally or in written form
- Non-English speaking
- Aged younger than 18 years
- Therapist Focus Discussion Groups:
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NUH Foundation Trust - Stroke Unit
Nottingham, Nottinghamshire, NG16 1RS
About this study
Official title: Early Electrical Stimulation to the Wrist Extensors and Wrist Flexors to Prevent the Post-stroke Complications of Pain and Contractures in the Paretic Arm - a Feasibility Study
Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function, muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly half of all stroke survivors. This can, in part, result from patients not getting adequate therapy targeting the hand and arm in the very early stages of rehabilitation. Previous research has highlighted the importance of early rehabilitation interventions after stroke. Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those who have retained some degree of active arm movement. Electrical stimulation (ES) is a painless treatment in which small pulses of electrical current from a battery operated portable device are used to activate a paralysed muscle and produce a strong muscle contraction. ES has been shown to increase brain activity and can hence influence the formation of new nerve pathways (known as neuroplasticity) to replace those damaged by stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the forearm improved the chance of a person recovering arm function. However, as the intensity of treatment was not sufficient to prevent the complications identified in this proposal, the impact of any functional benefit was significantly limited. We plan to build on previous research by training clinical therapists to operate ES devices; starting ES much earlier after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both the front and back of the forearm) and providing treatment for a longer period of time than previously carried out. We will evaluate the feasibility of incorporating ES into a patient self-management programme to enable independent use outside of routine therapist led rehabilitation sessions.
Read the detailed description
The study will evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive electrical stimulation (ES) to the wrist flexors and wrist extensors to prevent post stroke complications (such as pain and muscle contractures) to the paretic upper limb after stroke.
The feasibility study will involve a single centre feasibility randomised controlled trial and an integrated qualitative study (patient and carer interviews and therapist focus discussion groups).
Participants in the intervention group will receive electrical stimulation (ES) therapy. ES is similar to a TENS machine and delivers a constant stimulating current from 0 to 100 mA via two independent channels. The motor points for stimulation are already known. The therapist will identify the motor points for the forearm flexors (this will lead to a flexion movement of both the wrist and fingers) and the extensors (this will lead to an extensor of wrist and fingers), and will place an electrode on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450μs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed.
The devices required for this study have been donated by Verity Medical Ltd. The devices are CE marked and will be used in accordance with the manufacturer's marketing authorisation. Band 5 or above therapists will administer the initial ES treatment and mark the correct electrode placement.
The initial treatment will take between 15 and 20 minutes to assess the correct motor points. This is done by ensuring that a pure flexion or extension movement is produced with no ulnar or radial deviation. Once the motor points have been marked on the skin (using medical skin marker pens) any member of the therapy team band 3 or above can provide subsequent treatments which takes between 2-5 minutes to apply the electrode pads to the pre-marked motor points and switch on the device to the pre-stored treatment setting. The ES device will then provide treatment for 30 minutes, without the need for a therapist to remain present. It will be removed once the device has completed the set programme and switched itself off.
Patients and/or their carers will be shown by a therapist how to apply the electrode pads and use the device in under 10 minutes. Patients and/or their carers will be asked to self-manage the treatment upon discharge so that treatment can continue twice a day, 5 days a week, for a total period of 3 months. A patient diary will be included in the device case and participants and/or their nominated carer will be encouraged to record the times that the device is used.
Participants in the control group will not receive the electrical stimulation therapy intervention but will have access to all other usual services.
Ten pairs of patient participants and their nominated carers will be interviewed about their experience of using or supporting a loved one to use electrical stimulation therapy as part of a research study. The interviews will be used to examine issues regarding compliance with the ES treatment regime, acceptability of the ES treatment, experience of supporting a stroke survivor in using the ES treatment, any perceived treatment effects, the training that was provided and the ongoing support needs and any issues related to recruitment and consent. The purpose of these interviews is to identify issues related to delivering ES as part of a randomised controlled trial. The findings from these interviews will contribute to the final content and design of the research protocol for the definitive trial.
Each interview will last for around one hour in total and will take place in the participants' homes, or clinic if preferred, and will be recorded, transcribed verbatim and analysed thematically. Interviews will be conducted following completion of the 3 month follow-up assessments.
Five pairs of patient participants from the control group and their nominated carers will be interviewed to examine any issues from the perspective of the control group participants.
Four Physiotherapists and four occupational therapists from the Nottingham Stroke Unit will be invited to participate in a minimum of one and a maximum of three focus discussion groups during the course of the feasibility RCT. The focus groups will discuss the barriers and facilitators to successfully implementing the intervention and study protocol into clinical practice.
- Conditions
- Stroke
- Being tested
- NeuroTrac Rehab dual channel device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroTrac Rehab dual channel deviceDevice
Also called Electrical stimulation rehabilitation intervention
ES intervention twice a day, 5 days a week, for 3 months applied to the wrist extensors and wrist flexors. The therapist will identify the motor points for the forearm flexors and the extensors, and will place an electrode on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450μs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed.
| Study group | Role | What they receive |
|---|---|---|
| ES intervention | Experimental | Electrical stimulation (ES) twice a day, 5 days a week, for 3 months Receives: Device: NeuroTrac Rehab dual channel device |
| Control | No intervention | Usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the trial design
Recruitment rates: No./% of participants recruited within 72 hours post-stroke; and time post-stroke that participants received their first treatment; Recruitment strategy: No./% of patients screened, No./% eligible and approached, No./% who consented, No./% excluded after screening; Completion rates: No./% of participants who completed the intervention; No./% who completed the 3, 6 and 12 month follow-up assessments; Feasibility of delivering the intervention: No./% of participants who received ES twice a day, 5 days a week whilst in hospital, and No./% who continued with the treatment regime after discharge. Mean, min and max no. of ES treatments that participants received during the 3 month intervention period; Recruitment of patients lacking mental capacity to consent for themselves: Consultee consent rates (No./% of patients unable to give informed consent, and no. consented by a consultee, no. of consultees who declined consent)
Measured: 12 months
Tolerability
Proportion of participants who withdraw or decline intervention; Record of interventions declined and why.
Measured: 12 months
Integrity of the study protocol
Measured by examining how many participants are able to complete the study, % of missing data, and % of people who completed each of the outcome measures at 3, 6 and 12 month follow-up, calculation of the cost of running the study.
Measured: 12 months
Secondary outcomes (12)
NIHSS score
Neurological outcome and degree of recovery from stroke
Measured: 0, 3, 6, 12 months
Barthel ADL Index score and modified Rankin Score
Independence (functional ability) in basic daily activities
Measured: 0, 3, 6, 12 months
Scale of Pain Intensity (SPIN)
Pain in the affected arm
Measured: 0, 3, 6, 12 months
Muscle contractures (reduction in range of movement and spasticity)
Muscle contractures (reduction in range of movement and spasticity) will be monitored by measuring muscle activity during assessments using Biometrics equipment
Measured: 0, 3, 6, 12 months
Action Research Arm Test (ARAT)
Arm function
Measured: 0, 3, 6, 12 months
Stroke Specific Quality of Life Scale (SS-QOL)
Stroke related quality of life
Measured: 0, 3, 6, 12 months
EuroQoL-5D (EQ-5D)
Health status
Measured: 0, 3, 6, 12 months
Patient resource questionnaire
A measure of resource use and health related costs
Measured: 0, 3, 6, 12 months
Caregiver Strain Index (CSI)
Carer strain
Measured: 0, 3, 6, 12 months
Nottingham Extended ADL (NEADL)
Pre-morbid functional state
Measured: 0 months
The Montreal Cognitive Assessment (MoCA)
Cognitive status at baseline
Measured: 0 months
Patient resource use (cost) questionnaire
A questionnaire to measure resource use and associated health costs.
Measured: 0, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start1 Jun 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Keele University, University of Southampton, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Joanna C Fletcher-Smith, PhD; MPhil; BSc, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324634
- Sponsor's protocol ID
- 14110
- Acronym
- ESCAPS
- Status last verified
- May 2017
- First submitted
- 10 Dec 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fletcher-Smith JC, Walker DM, Sprigg N, James M, Walker MF, Allatt K, Mehta R, Pandyan AD. ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'. BMJ Open. 2016 Jan 4;6(1):e010079. doi: 10.1136/bmjopen-2015-010079.
PubMed 26729394
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Electrical Stimulation to the Wrist Extensors and Wrist Flexors to Prevent the Post-stroke Complications of Pain and Contractures in the Paretic Arm - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02324634
- Acronym / sponsor ID
- ESCAPS / 14110
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Keele University, University of Southampton, Nottingham University Hospitals NHS Trust
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function, muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly half of all stroke survivors. This can, in part, result from patients not getting adequate therapy targeting the hand and arm in the very early stages of rehabilitation. Previous research has highlighted the importance of early rehabilitation interventions after stroke. Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those who have retained some degree of active arm movement. Electrical stimulation (ES) is a painless treatment in which small pulses of electrical current from a battery operated portable device are used to activate a paralysed muscle and produce a strong muscle contraction. ES has been shown to increase brain activity and can hence influence the formation of new nerve pathways (known as neuroplasticity) to replace those damaged by stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the forearm improved the chance of a person recovering arm function. However, as the intensity of treatment was not sufficient to prevent the complications identified in this proposal, the impact of any functional benefit was significantly limited. We plan to build on previous research by training clinical therapists to operate ES devices; starting ES much earlier after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both the front and back of the forearm) and providing treatment for a longer period of time than previously carried out. We will evaluate the feasibility of incorporating ES into a patient self-management programme to enable independent use outside of routine therapist led rehabilitation sessions.
Detailed description
The study will evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive electrical stimulation (ES) to the wrist flexors and wrist extensors to prevent post stroke complications (such as pain and muscle contractures) to the paretic upper limb after stroke.
The feasibility study will involve a single centre feasibility randomised controlled trial and an integrated qualitative study (patient and carer interviews and therapist focus discussion groups).
Participants in the intervention group will receive electrical stimulation (ES) therapy. ES is similar to a TENS machine and delivers a constant stimulating current from 0 to 100 mA via two independent channels. The motor points for stimulation are already known. The therapist will identify the motor points for the forearm flexors (this will lead to a flexion movement of both the wrist and fingers) and the extensors (this will lead to an extensor of wrist and fingers), and will place an electrode on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450μs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed.
The devices required for this study have been donated by Verity Medical Ltd. The devices are CE marked and will be used in accordance with the manufacturer's marketing authorisation. Band 5 or above therapists will administer the initial ES treatment and mark the correct electrode placement.
The initial treatment will take between 15 and 20 minutes to assess the correct motor points. This is done by ensuring that a pure flexion or extension movement is produced with no ulnar or radial deviation. Once the motor points have been marked on the skin (using medical skin marker pens) any member of the therapy team band 3 or above can provide subsequent treatments which takes between 2-5 minutes to apply the electrode pads to the pre-marked motor points and switch on the device to the pre-stored treatment setting. The ES device will then provide treatment for 30 minutes, without the need for a therapist to remain present. It will be removed once the device has completed the set programme and switched itself off.
Patients and/or their carers will be shown by a therapist how to apply the electrode pads and use the device in under 10 minutes. Patients and/or their carers will be asked to self-manage the treatment upon discharge so that treatment can continue twice a day, 5 days a week, for a total period of 3 months. A patient diary will be included in the device case and participants and/or their nominated carer will be encouraged to record the times that the device is used.
Participants in the control group will not receive the electrical stimulation therapy intervention but will have access to all other usual services.
Ten pairs of patient participants and their nominated carers will be interviewed about their experience of using or supporting a loved one to use electrical stimulation therapy as part of a research study. The interviews will be used to examine issues regarding compliance with the ES treatment regime, acceptability of the ES treatment, experience of supporting a stroke survivor in using the ES treatment, any perceived treatment effects, the training that was provided and the ongoing support needs and any issues related to recruitment and consent. The purpose of these interviews is to identify issues related to delivering ES as part of a randomised controlled trial. The findings from these interviews will contribute to the final content and design of the research protocol for the definitive trial.
Each interview will last for around one hour in total and will take place in the participants' homes, or clinic if preferred, and will be recorded, transcribed verbatim and analysed thematically. Interviews will be conducted following completion of the 3 month follow-up assessments.
Five pairs of patient participants from the control group and their nominated carers will be interviewed to examine any issues from the perspective of the control group participants.
Four Physiotherapists and four occupational therapists from the Nottingham Stroke Unit will be invited to participate in a minimum of one and a maximum of three focus discussion groups during the course of the feasibility RCT. The focus groups will discuss the barriers and facilitators to successfully implementing the intervention and study protocol into clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES intervention | Experimental | Device: NeuroTrac Rehab dual channel deviceElectrical stimulation (ES) twice a day, 5 days a week, for 3 months |
| Control | No intervention | –Usual care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb
- Patients aged 18 years or over
- Impaired arm movement and strength resulting in reduced function, caused specifically by the stroke. (as determined by the arm subsection score of the National Institute for Health Stroke Scale (NIHSS)
- Nominated carer for a patient participating in the feasibility RCT
- Patients or carers who are participating in the main feasibility RCT
Key exclusion criteria (13 listed)
- Patients with a previous history of stroke affecting their upper limb will be excluded as a chronic limb condition from a previous stroke could affect the results
- Patients will also be excluded with peripheral nerve injury of the upper limb; an existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy.
- Patients with a cardiac pacemaker or similar implanted device.
- Pregnancy
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroTrac Rehab dual channel deviceAlso: Electrical stimulation rehabilitation interventionES intervention twice a day, 5 days a week, for 3 months applied to the wrist extensors and wrist flexors. The therapist will identify the motor points for the forearm flexors and the extensors, and will place an electrode on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450μs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed. | Device | ES intervention |
Primary outcome
Feasibility of the trial design
Time frame: 12 months
Recruitment rates: No./% of participants recruited within 72 hours post-stroke; and time post-stroke that participants received their first treatment; Recruitment strategy: No./% of patients screened, No./% eligible and approached, No./% who consented, No./% excluded after screening; Completion rates: No./% of participants who completed the intervention; No./% who completed the 3, 6 and 12 month follow-up assessments; Feasibility of delivering the intervention: No./% of participants who received ES twice a day, 5 days a week whilst in hospital, and No./% who continued with the treatment regime after discharge. Mean, min and max no. of ES treatments that participants received during the 3 month intervention period; Recruitment of patients lacking mental capacity to consent for themselves: Consultee consent rates (No./% of patients unable to give informed consent, and no. consented by a consultee, no. of consultees who declined consent)
Tolerability
Time frame: 12 months
Proportion of participants who withdraw or decline intervention; Record of interventions declined and why.
Integrity of the study protocol
Time frame: 12 months
Measured by examining how many participants are able to complete the study, % of missing data, and % of people who completed each of the outcome measures at 3, 6 and 12 month follow-up, calculation of the cost of running the study.
12 secondary outcomes
NIHSS score
Time frame: 0, 3, 6, 12 months
Barthel ADL Index score and modified Rankin Score
Time frame: 0, 3, 6, 12 months
Scale of Pain Intensity (SPIN)
Time frame: 0, 3, 6, 12 months
Muscle contractures (reduction in range of movement and spasticity)
Time frame: 0, 3, 6, 12 months
Action Research Arm Test (ARAT)
Time frame: 0, 3, 6, 12 months
Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: 0, 3, 6, 12 months
EuroQoL-5D (EQ-5D)
Time frame: 0, 3, 6, 12 months
Patient resource questionnaire
Time frame: 0, 3, 6, 12 months
Caregiver Strain Index (CSI)
Time frame: 0, 3, 6, 12 months
Nottingham Extended ADL (NEADL)
Time frame: 0 months
The Montreal Cognitive Assessment (MoCA)
Time frame: 0 months
Patient resource use (cost) questionnaire
Time frame: 0, 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 26729394Fletcher-Smith JC, Walker DM, Sprigg N, James M, Walker MF, Allatt K, Mehta R, Pandyan AD. ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'. BMJ Open. 2016 Jan 4;6(1):e010079. doi: 10.1136/bmjopen-2015-010079.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna C Fletcher-Smith, PhD; MPhil; BSc principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroTrac Rehab dual channel device in people with Stroke, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the trial design (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.