N/A
N=24
Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04338971 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Fugl-Meyer Assessment - Upper Extremity — 9.18 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IpsiHand Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurolutions, Inc.
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment - Upper Extremity |
9.18 | — |
| SECONDARY Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks |
12.65 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04338971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.