Stroke Clinical Trial
Official title:
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
NCT number | NCT06023316 |
Other study ID # | mGain-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 8, 2023 |
Est. completion date | March 1, 2024 |
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when compared to standard of care and will be feasible, acceptable, and usable in individuals with upper limb weakness or limb amputation. All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Upper limb weakness due to central or peripheral neurologic injury, stroke, or nerve reconstruction or tendon transfer surgery within one year; or upper limb amputation (e.g., transradial or transhumeral) - Muscle strength of three or less on the Medical Research Council Manual Muscle Testing grading scale in any of the following (as appropriate for individuals with intact limbs): shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist flexion, or finger extension - Access to and willingness to use smart phone or tablet - Able to tolerate participation in activity for at least 30 minutes of therapy exercises per day for five days per week - Able to provide written informed consent for study participation Exclusion Criteria: - Not able to read and understand English - Pregnancy - History of prior central or peripheral neurologic injury or neuromuscular condition - No muscle activation detectable by the mGain sEMG sensor - Progressive neurologic deficit - Impaired dexterity on the contralateral side such that participant is unable to use the device - Spasticity with modified Ashworth score of three or greater - Severe joint contracture (>50% of available range) - Sensitive skin that would not tolerate wearing the mGain sEMG sensor - Medical instability - Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation |
Country | Name | City | State |
---|---|---|---|
United States | Orthocare Innovations, LLC | Edmonds | Washington |
Lead Sponsor | Collaborator |
---|---|
Orthocare Innovations, LLC | National Institute on Disability, Independent Living, and Rehabilitation Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre Self-Efficacy | The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy. | At initial assessment before using intervention | |
Primary | Post Self-Efficacy | The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy. | Four weeks (at final assessment after using intervention for four weeks) | |
Primary | System Usability Scale | The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average. | Four weeks (at final assessment after using intervention for four weeks) | |
Secondary | pre-QuickDASH | QuickDASH (Disabilities of the Arm, Shoulder and Hand) is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability | At initial assessment before using intervention | |
Secondary | post-QuickDASH | QuickDASH is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability | Four weeks (at final assessment after using intervention for four weeks) |
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