Hemiparesis of the Upper Limb Following Stroke Clinical Trial
Official title:
Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke
| NCT number | NCT02266836 |
| Other study ID # | MT-ST-2001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | October 2015 |
| Verified date | August 2019 |
| Source | MyndTec Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Ischemic or hemorrhagic stroke confirmed by MRI or CT scan 2. Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke 3. Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand) 4. Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19 5. Subject is able to follow instructions 6. Subject is able to sit and participate in one hour of upper limb therapy 7. Anticipated to be discharged home or already at home following conventional inpatient rehabilitation 8. Willing to attend outpatient therapy if chronic or late sub-acute 9. Subject is able and willing to give written informed consent 10. Men and women aged 18 or older Exclusion Criteria: 1. Global Aphasia 2. Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding 3. Upper extremity injury or condition prior to stroke that limits the function of the hand or arm 4. Life expectancy of less than 12 months due to other illness 5. Subject has malignant skin lesion on the affected upper extremity 6. Subject has history of seizure disorder and on seizure medications 7. Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation) 8. Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS) 9. Subject has rash or open wound at any potential electrode site 10. In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study 11. Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study 12. Currently enrolled in another upper limb study 13. Enrolled in the past six months in a clinical study involving drugs or biologics |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| MyndTec Inc. | University Health Network, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in 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 | Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects | To measure the degree of disability the Functional Independence Measure will be completed. The FIM consists of 18 items of which 13 are motor related tasks and 5 are cognitive related items. The measure is broken down into 6 classifications of self-care, sphincter control, mobility, locomotion, communication and social cognition. The self-care consists of 6 items: eating, grooming, bathing, dressing-upper body, dressing-lower body, toileting. Each item is rated using a 7-point scale indicating the level of functioning from total assistance with a score of 1 to complete independence with a score of 7. | Baseline - 6 weeks | |
| Secondary | System Usability Scale | Each Therapist will complete the System Usability Scale on the last treatment visit which is expected to be an average of 5 weeks after therapy has begun. Each question in the System Usability Scale is scored from 1 - Strongly Disagree, through to 5 - Strongly Agree. System Usability Scale scores, based on therapist assessments, at end of study compared to baseline (after basic training). | An average of 5 weeks after therapy has begun | |
| Secondary | All adverse events | At each study visit, participants will be asked if they have experienced any adverse events. Participants will be in the study for an expected average of 5 weeks. | Baseline - An average of 5 weeks after therapy has begun | |
| Secondary | Amplitudes to elicit muscle movement | The amplitudes that are used to elicit the muscle movement will be recorded for the various muscles for each participant. The average required amplitude will be calculated and the minimum and maximum amplitudes will be noted. This will provide future guidance on the typical range of amplitudes needed for the various muscles to treat patients. | Throughout study |