Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorNeurolutions, Inc.
About this trial
This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult age 18-85 years.
Diagnosis of stroke six or more months prior with upper extremity weakness.
Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.
Disqualifiers
Severe cognitive impairment that would impede utilization of IpsiHand®
Any contraindications to IpsiHand® device use
Inability to comprehend English
Trial population
Chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing rehabilitation using the IpsiHand® System.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IpsiHand
DeviceIpsiHand is a therapeutic device that uses a brain-computer interface system which detects neural signals associated with motor intent and translates them into assisted hand movements in individuals with upper extremity impairment following a stroke.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Adult stroke patients with upper extremity hemiparesis.1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time frame
Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.Secondary outcomes
1
The Barthel Index
Assessment tool that measures a person's functional independence in activities of daily living and self-care.
Time frame
Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.2
Zarit Caregiver Burden Scale (ZBI)
Widely used questionnaire designed to assess the level of burden experienced by caregivers.
Time frame
Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.3
Patient Specific Functional Scale (PSFS)
patient-reported outcome measure used to assess an individual's ability to perform specific functional activities that are important to them. It is commonly used in rehabilitation and clinical settings to track progress over time in response to treatment.
Time frame
Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.4
Euro-QOL5D5L
Patient-reported outcome measure used to assess health-related quality of life (HRQoL) across different diseases and treatments. It is widely used in clinical research, health economics, and healthcare decision-making to quantify the impact of health conditions and interventions on daily living
Time frame
Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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