NCT03323632

Brief Summary

The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses of electrical current amplitudes, the usability of the device, and examining the overall safety.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 27, 2017

Status Verified

August 1, 2014

Enrollment Period

4.2 years

First QC Date

October 24, 2017

Last Update Submit

October 24, 2017

Conditions

Stroke

Keywords

StrokeCerebrovascular accidentUpper extremityCerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersCardiovascular DiseasesNervous System DiseasesCentral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Fugl-Meyer Assessment (UE-FMA)

    The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized scale used for the evaluation of physical performance in the post-stroke hemiplegic patient. The upper extremity (UE) evaluates the function of the upper extremity motor function in four components: Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks. The maximum score associated with the UE-FMA is 66 points. Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed. Partial function can be scored as 1 for selected tasks. This evaluation will be completed by a trained physiotherapist or occupational therapist. Upper extremity assessment for stroke patients. Clinically Significant change is \>6 points

    baseline to 6 weeks

Secondary Outcomes (1)

  • FIM and Self - Care FIM

    Baseline - 6 weeks

Study Arms (1)

MyndMove

EXPERIMENTAL

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 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.

Device: MyndMove

Interventions

MyndMoveDEVICE

During a MyndMove therapy session, the patient is instructed to attempt to execute a task voluntarily. As the patient is attempting to perform the designated task, specific muscles in the arm are stimulated to generate contractions that produce the desired movement. After a brief interval of the patient attempting to initiate a movement the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contractions enabling the patient to complete the desired/instructed task. Proper sequencing of the muscle contractions as per the MyndMove protocols are tailored to achieve a wide range of reaching and grasping functions. The technique stimulates non-damaged pathways of the central nervous system.

MyndMove

Eligibility Criteria

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

You may qualify if:

  • Ischemic or hemorrhagic stroke confirmed by MRI or CT scan
  • Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke
  • Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand)
  • Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19
  • Subject is able to follow instructions
  • Subject is able to sit and participate in one hour of upper limb therapy
  • Anticipated to be discharged home or already at home following conventional inpatient rehabilitation
  • Willing to attend outpatient therapy if chronic or late sub-acute
  • Subject is able and willing to give written informed consent
  • Men and women aged 18 or older

You may not qualify if:

  • Global Aphasia
  • Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding
  • Upper extremity injury or condition prior to stroke that limits the function of the hand or arm
  • Life expectancy of less than 12 months due to other illness
  • Subject has malignant skin lesion on the affected upper extremity
  • Subject has history of seizure disorder and on seizure medications
  • Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation)
  • Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS)
  • Subject has rash or open wound at any potential electrode site
  • In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study
  • Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study
  • Currently enrolled in another upper limb study
  • Enrolled in the past six months in a clinical study involving drugs or biologics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehab Inst, UHN

Toronto, Ontario, M5G2A2, Canada

Location

Related Publications (1)

  • Hebert, D, Bowen, J. M., Ho, C. Antunes, I, O'Reilly, D. J. and Bayley, M. (2017) Examining a new functional electrical stimulation therapy with people with sever upper extremity hemiparesis and chronic stroke: A feasibility study. British Journal of Occupational Therapy. 0/0: 1 - 10.

    BACKGROUND

MeSH Terms

Conditions

StrokeCerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersCardiovascular DiseasesNervous System DiseasesCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Debbie A Hebert, MSc(Kin)

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

August 1, 2014

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

October 27, 2017

Record last verified: 2014-08

Locations

CA(1)