National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Launched by NEUROLUTIONS, INC. · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people recover from stroke-related arm weakness, called hemiparesis. The study will compare a special device called the IpsiHand, which helps move the arm using brain signals, to standard exercise therapy. The goal is to see if using this remote device at home can improve arm movement in people who had a stroke. Participants will be randomly assigned to either the IpsiHand group or the standard therapy group, so everyone has a fair chance of getting one of the treatments.

To be eligible for the trial, participants need to be adults aged 18 to 85 who have experienced a stroke and have weakness in one arm. They should not be currently receiving certain treatments like Botox for arm spasms, and they need to be able to understand instructions. The trial has not started recruiting participants yet, but those who join can expect to take part in therapy sessions from home and help researchers learn more about this innovative approach to stroke rehabilitation.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.