HemiparesisNCT03147794
Functional Electrical Stimulation for Children With Upper Limb Weakness Post Stroke
A study testing MyndMove in people with Hemiparesis and Stroke, run by Holland Bloorview Kids Rehabilitation Hospital.
Trial summary
A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Hemiparesis, Stroke
- What is being tested?
- MyndMove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ischaemic or Haemorrhagic stroke with hemiparesis of the upper extremity; ii) Willing to attend therapy; and iii) Communicate effectively in English.
Who cannot join
- Global aphasia; ii) Upper extremity condition that limits the function of the hand and arm before the stroke; iii) Active seizure disorder within 5 years; iv) Implanted pacemaker, vagal nerve stimulator, AICD, baclofen pump, or similar implanted metallic or electronic device; v) Unhealed fracture or wound in the affected arm; vi) BOTOX injection into the affected arm or hand within 6 months; vii) Currently enrolled in another study of upper limb therapy or new investigational drugs/biologics within 6 months; viii) Swollen, infected or inflamed areas or skin eruptions on the affected arm including evidence of phlebitis or venous incompetence in the arm; ix) Known cardiac dysrhythmia; x) cancerous or suspected cancerous lesions present on the affected arm and xi) Cognitive impairment sufficient enough to impede in the following of directions and understanding of the nature of the therapy, xii) Unwilling/unable to assent to study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Functional Electrical Stimulation Therapy for Children With Upper Limb Weakness Post Stroke: Evaluation of the Mynd Move Technology
A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial looking at adults with acute stroke and limited or complete immobility of the arm, FES and intensive therapy was shown to have significant improvement of hand function compared to the control group that was exposed to intensive therapy only (8). Limited research using MyndMove to administer FES has been conducted for pediatric populations, however there is significant potential for FES and intensive therapy to improve hand function for children with upper extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated and proven for this age group.
Read the detailed description
Research Questions and Objectives:
The overall goal of this study is to determine if therapy administered using MyndMove can be tolerated by children age 3 to 6 with upper extremity hemiparesis and produce effective response without injury or pain.
The objectives of this study are:
- To evaluate the tolerability of MyndMove technology to safely provide Functional Electrical Stimulation (FES) transdermally as therapy in young children From these findings the researchers aim to:
- To establish clinical recommendations for the next step of this study, which will evaluate the efficacy of MyndMove therapy with this population using a pre-post case series model .
Specifically, this study will answer the following research questions:
- Can MyndMove FES stimulation be tolerated by young children ages 3 to 6 with upper extremity hemiparesis without pain or discomfort? he following of directions and understanding of the nature of the therapy.
Intervention All participants in this study will receive transcutaneous functional electrical stimulation via MyndMove administered by trained occupational therapists (OTs) from the Acquired Brain Injury department at Holland Bloorview Kids Rehabilitation Hospital. The MyndMove system is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following stroke or spinal cord injury. MyndMove delivers therapeutic stimulation sequences called protocols, which are coded therapeutic algorithms which assist muscle contractions for arm and hand movement allowing the brain and central nervous system to be retrained, restoring voluntary reaching and grasping functions lost following neurological injury. The MyndMove system comprises the hardware device, stimulation electrodes and cables, hand and foot switches, and integrated software. OTs will be trained at a 2-day course that trains users on the MyndMove system. The purpose of the workshop is to train users how to safely and effectively use the system, screen for contraindications, and identify eligible clients for MyndMove. OTs will receive instructions on available training protocol and the application of the protocol. The course also includes a practical component, focusing on establishing user's comfort with the MyndMove system (see Appendix 9 for the MyndMove Course Training Outline).
FES will be delivered while participants engage in task-oriented activities that require reaching and grasping. Neuromuscular recover in stroke patients typically starts with recovery of proximal parts and then recovery of distal parts. Therefore, the research team will test tolerability proximally to distally in the protocol. The participant will be asked to perform three to five of the following movements: 1) touch nose, 2) touch opposite shoulder, 3) touch forehead, 4) move arm forward, 5) lift affected arm up and extend elbow, 6) hand opening, 7) palmar grasp, 8) pinch grasp, 9) lateral pinch grasp, and 10) lumbrical grasp. In long-term therapeutic FES interventions, once participants are able to voluntarily control these shoulder and elbow movements, the OT would proceed to focus on the distal parts of the arm. However, because this is a tolerability study and FES will only be administered in one session, the OTs will test the distal parts of the arm even if the participant has not achieved voluntary control of their shoulder and elbow movements. The participants will be asked to perform each specific task for an interval of 10 to 20 seconds. Participants will repeat each task 10 or more times, or as long as the one hour session allows. This session will involve the parent and a child life specialist to increase the child's acceptance during the therapy and to assist in the process of detecting and mitigating discomfort during sessions. Observations will be recorded by the OT as in Part 1. During and after the session, the OT will look for signs and symptoms of discomfort.
- Conditions
- Hemiparesis, Stroke
- Being tested
- MyndMove
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyndMoveDevice
A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| FES using MyndMove Technology | Experimental | This is the only arm of the study. Participants will be provided with the FES intervention as part of the protocol. Receives: Device: MyndMove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Scale
This is a pain scale.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".
Measured: Administered at Appointment 2 (Day 7 of study)
Secondary outcomes (1)
Quality of Upper Extremity Skills Test (QUEST)
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid.
Measured: Administered at appointment 1 (Day 0 of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MyndTec Inc.
- Responsible party
- Sponsor
- Investigators
- Peter Rumney, MD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147794
- Sponsor's protocol ID
- FES Study
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers will not make individual patient data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Therapy for Children With Upper Limb Weakness Post Stroke: Evaluation of the Mynd Move Technology
- ClinicalTrials.gov ID
- NCT03147794
- Acronym / sponsor ID
- FES Study
- Conditions
- Hemiparesis, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- MyndTec Inc.
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial looking at adults with acute stroke and limited or complete immobility of the arm, FES and intensive therapy was shown to have significant improvement of hand function compared to the control group that was exposed to intensive therapy only (8). Limited research using MyndMove to administer FES has been conducted for pediatric populations, however there is significant potential for FES and intensive therapy to improve hand function for children with upper extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated and proven for this age group.
Detailed description
Research Questions and Objectives:
The overall goal of this study is to determine if therapy administered using MyndMove can be tolerated by children age 3 to 6 with upper extremity hemiparesis and produce effective response without injury or pain.
The objectives of this study are:
- To evaluate the tolerability of MyndMove technology to safely provide Functional Electrical Stimulation (FES) transdermally as therapy in young children From these findings the researchers aim to:
- To establish clinical recommendations for the next step of this study, which will evaluate the efficacy of MyndMove therapy with this population using a pre-post case series model .
Specifically, this study will answer the following research questions:
- Can MyndMove FES stimulation be tolerated by young children ages 3 to 6 with upper extremity hemiparesis without pain or discomfort? he following of directions and understanding of the nature of the therapy.
Intervention All participants in this study will receive transcutaneous functional electrical stimulation via MyndMove administered by trained occupational therapists (OTs) from the Acquired Brain Injury department at Holland Bloorview Kids Rehabilitation Hospital. The MyndMove system is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following stroke or spinal cord injury. MyndMove delivers therapeutic stimulation sequences called protocols, which are coded therapeutic algorithms which assist muscle contractions for arm and hand movement allowing the brain and central nervous system to be retrained, restoring voluntary reaching and grasping functions lost following neurological injury. The MyndMove system comprises the hardware device, stimulation electrodes and cables, hand and foot switches, and integrated software. OTs will be trained at a 2-day course that trains users on the MyndMove system. The purpose of the workshop is to train users how to safely and effectively use the system, screen for contraindications, and identify eligible clients for MyndMove. OTs will receive instructions on available training protocol and the application of the protocol. The course also includes a practical component, focusing on establishing user's comfort with the MyndMove system (see Appendix 9 for the MyndMove Course Training Outline).
FES will be delivered while participants engage in task-oriented activities that require reaching and grasping. Neuromuscular recover in stroke patients typically starts with recovery of proximal parts and then recovery of distal parts. Therefore, the research team will test tolerability proximally to distally in the protocol. The participant will be asked to perform three to five of the following movements: 1) touch nose, 2) touch opposite shoulder, 3) touch forehead, 4) move arm forward, 5) lift affected arm up and extend elbow, 6) hand opening, 7) palmar grasp, 8) pinch grasp, 9) lateral pinch grasp, and 10) lumbrical grasp. In long-term therapeutic FES interventions, once participants are able to voluntarily control these shoulder and elbow movements, the OT would proceed to focus on the distal parts of the arm. However, because this is a tolerability study and FES will only be administered in one session, the OTs will test the distal parts of the arm even if the participant has not achieved voluntary control of their shoulder and elbow movements. The participants will be asked to perform each specific task for an interval of 10 to 20 seconds. Participants will repeat each task 10 or more times, or as long as the one hour session allows. This session will involve the parent and a child life specialist to increase the child's acceptance during the therapy and to assist in the process of detecting and mitigating discomfort during sessions. Observations will be recorded by the OT as in Part 1. During and after the session, the OT will look for signs and symptoms of discomfort.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES using MyndMove Technology | Experimental | Device: MyndMoveThis is the only arm of the study. Participants will be provided with the FES intervention as part of the protocol. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ischaemic or Haemorrhagic stroke with hemiparesis of the upper extremity; ii) Willing to attend therapy; and iii) Communicate effectively in English.
Key exclusion criteria (1 listed)
- Global aphasia; ii) Upper extremity condition that limits the function of the hand and arm before the stroke; iii) Active seizure disorder within 5 years; iv) Implanted pacemaker, vagal nerve stimulator, AICD, baclofen pump, or similar implanted metallic or electronic device; v) Unhealed fracture or wound in the affected arm; vi) BOTOX injection into the affected arm or hand within 6 months; vii) Currently enrolled in another study of upper limb therapy or new investigational drugs/biologics within 6 months; viii) Swollen, infected or inflamed areas or skin eruptions on the affected arm including evidence of phlebitis or venous incompetence in the arm; ix) Known cardiac dysrhythmia; x) cancerous or suspected cancerous lesions present on the affected arm and xi) Cognitive impairment sufficient enough to impede in the following of directions and understanding of the nature of the therapy, xii) Unwilling/unable to assent to study.
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 |
|---|---|---|
| MyndMoveA new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury. | Device | FES using MyndMove Technology |
Primary outcome
Wong-Baker Faces Pain Scale
Time frame: Administered at Appointment 2 (Day 7 of study)
This is a pain scale.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".
1 secondary outcome
Quality of Upper Extremity Skills Test (QUEST)
Time frame: Administered at appointment 1 (Day 0 of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No. The researchers will not make individual patient data available to other researchers.
Related trials for Hemiparesis
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
RecruitingObservational study
Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
Stroke, Hemiparesis
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.
Peter Rumney, MD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
A study testing MyndMove in people with Hemiparesis and Stroke, run by Holland Bloorview Kids Rehabilitation Hospital.
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 1 inclusion and 1 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Peter Rumney, MD (416-425-6220 ext. 6019, prumney@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Faces Pain Scale (time frame: Administered at Appointment 2 (Day 7 of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.