COMPLETED

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Conditions

Stroke Hemiparesis Spasticity as Sequela of Stroke Brain Computer Interface Neurolutions IpsiHand

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).

Official Title

IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial

Quick Facts

Study Start:2023-10-01

Study Completion:2025-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05965713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults age (18-85) 2. Adults who sustained a CVA 3. Have upper extremity hemiparesis/hemiplegia 4. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.	1. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training. 2. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded. 3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. 4. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded. 5. Participants receiving any formal upper extremity therapy will be excluded. 6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. 7. Participants who are pregnant or breast-feeding will be excluded. 8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Inclusion Criteria

Exclusion Criteria

1. Adults age (18-85)
2. Adults who sustained a CVA
3. Have upper extremity hemiparesis/hemiplegia
4. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.

1. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
2. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
4. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
5. Participants receiving any formal upper extremity therapy will be excluded.
6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
7. Participants who are pregnant or breast-feeding will be excluded.
8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Contacts and Locations

Principal Investigator

Alexandre Carter, MD, PhD

PRINCIPAL_INVESTIGATOR

Washington University in Saint Louis

Study Locations (Sites)

Washington University in Saint Louis

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Neurolutions, Inc.

Alexandre Carter, MD, PhD, PRINCIPAL_INVESTIGATOR, Washington University in Saint Louis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01

Study Completion Date2025-10-30

Study Record Updates

Study Start Date2023-10-01

Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

Neurolutions
IpsiHand

Additional Relevant MeSH Terms

Stroke
Hemiparesis
Spasticity as Sequela of Stroke
Brain Computer Interface