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Completed

NCT Number: NCT05965713

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

About this study

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age (18-85)
  • Adults who sustained a CVA
  • Have upper extremity hemiparesis/hemiplegia
  • 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

  • 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.
  • 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.
  • Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
  • 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.
  • Participants receiving any formal upper extremity therapy will be excluded.
  • Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
  • Participants who are pregnant or breast-feeding will be excluded.
  • Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Treatment and study plan

Neurolutions IpsiHand System

Device

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 home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline and at 12 weeks completion of IpsiHand use.

Standard of Care - Home Exercise Program for Upper Extremity

Other

Subjects will receive a customized standard of care home exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks.

Primary outcomes

  1. Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form

    Time frame: Assessed at baseline visit and at completion of study

    Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.

Secondary outcomes

  1. Neurolutions Upper Extremity Remote Assessment (Remote Digital Fugl Meyer)

    Time frame: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment

    Shortened and validated digitized assessment tool derived from the Fugl-Meyer Long form developed by Neurolutions of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Embedded into study software. Lowest score 0, highest score 66.

  2. Pinch force (Dynamometer)

    Time frame: Baseline and 12 week completion assessment

    Evaluation of two and three point pinch strength via dynamometry; lowest score= 0lbs, highest score =150lbs

  3. Gross Grasp (Dynamometer)

    Time frame: Baseline and 12 week completion assessment

    Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs

  4. Motricity Index (Shoulder, Elbow, Pinch)

    Time frame: Baseline and 12 week completion assessment

    Evaluation of motor strength on the shoulder, elbow and pinch. Scored on a 0-5 scale. 0 being totally absent muscle strength and range of motion, 5 bring full strength and range of motion of limb.

  5. Western Aphasia Battery (Bedside Record Form)

    Time frame: Baseline and 12 week completion assessment

    Assessment of language function for classification of aphasia following a stoke.

  6. Timed Up and Go Test (TUG)

    Time frame: Baseline and 12 week completion assessment

    Assessment functional mobility and fall risk

  7. 10 Meter Walking Test

    Time frame: Baseline and 12 week completion assessment

    Assessment functional mobility, speed of mobility and fall risk

  8. Arm Motor Ability Test (4 Subtests Only)

    Time frame: Baseline and 12 week completion assessment

    Assessment to evaluate upper extremity function in activities of daily living

  9. Trail Making Test- Parts A and B

    Time frame: Baseline and 12 week completion assessment

    Assessment of general cognitive function specifically assesses working memory, visual processing, visuospatial skills, selective and divided attention.

  10. Modified Rankin Scale

    Time frame: Baseline and 12 week completion assessment

    A widely used assessment tool for measuring the degree of disability or dependence in people who have experienced stroke or other neurological conditions. The sale ranges from 0 (no symptoms) to 6 (death), and is commonly used as a primary outcome measure in stroke clinical trials.

  11. PHQ-9

    Time frame: Baseline and 12 week completion assessment

    A widely used assessment tool for self reporting of depression. This assessment is scored from 0-27.

    0-4: Minimal or no depression. 5-9: Mild depression. 10-14: Moderate depression. 15-19: Moderately severe depression. 20-27: Severe depression.

  12. Zarit Burden Interview (ZBI)

    Time frame: Baseline and 12 week completion assessment

    Widely used questionnaire designed to assess the level of burden experienced by caregivers

  13. The Barthel Index

    Time frame: Baseline and 12 week completion assessment

    Assessment tool that measures a person's functional independence in activities of daily living and self-care

Sponsors and collaborators

Lead sponsor

Neurolutions, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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