Stroke
Conditions
Keywords
Rehabilitation, Brain-Computer Interface
Brief summary
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.
Detailed description
Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.
Interventions
DEVICEIpsiHand Therapy
The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.
Sponsors
Neurolutions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 6-months or more post stroke * Presentation of upper extremity hemiparesis or hemiplegia * Participants must english speaking * Demonstrate intact cognition to provide informed consent * Botox injections are allowed, and must continue regimen at regular intervals throughout the study
Exclusion criteria
- * Not active in another clinical study * Not receiving formal therapy for the upper extremity * No use of other modalities or technologies to the upper extremity * Cognitive Impairment: Short Blessed Test Score 9 or above * Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow * Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally * Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity | "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score. | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks | Change in AMAT score (points) from Baseline to 12 Weeks | The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexandre Carter, MD, PhD
Principal Investigator
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IpsiHand Intervention This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the device) at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System.
IpsiHand is a device which includes a robotic exoskeleton that you wear on your forearm and hand, an EEG headset worn on your head, and a tablet which includes therapy software and guides you through daily therapy exercises.
Once a participant completes an initial EEG screening, the participant completes a set of baseline measurements, the IpsiHand BCI device is then provided to the participants and are to be used a minimum of 5 days a week out of 7 days , for a total duration of 12 weeks. Participants are seen monthly throughout the 12-week duration while they are using the IpsiHand. After completion of device use, participants were asked to be evaluated 6 months after discontinuation of the IpsiHand to assess durability effects. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | IpsiHand Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Baseline Scores of the "Fugl Meyer Assessment of the Upper Extremity" Score | 9.18 Units on a scale STANDARD_DEVIATION 5.836 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Fugl-Meyer Assessment - Upper Extremity
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.
Time frame: Fugl-Meyer Assessment - Upper Extremity average change in points from the baseline average score and 12-week average score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IpsiHand Intervention: Change in Fugl-Meyer Assessment of the Upper Extremity | Fugl-Meyer Assessment - Upper Extremity | 9.18 point change for score on assessment | Standard Deviation 5.836 |
Secondary
Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks
The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points
Time frame: Change in AMAT score (points) from Baseline to 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IpsiHand Intervention: Change in Fugl-Meyer Assessment of the Upper Extremity | Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks | 12.65 change in points of score on a scale | Standard Deviation 4.105 |