Back to resultsIpsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IpsiHand Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Brain-Computer Interface
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
Sites / Locations
- Neurolutions
- Neurolutions
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IpsiHand Device
Arm Description
All participants will receive treatment with the IpsiHand Device.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment - Upper Extremity
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.
Secondary Outcome Measures
Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks
The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338971
Brief Title
Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Official Title
Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolutions, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Brain-Computer Interface
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IpsiHand Device
Arm Type
Experimental
Arm Description
All participants will receive treatment with the IpsiHand Device.
Intervention Type
Device
Intervention Name(s)
IpsiHand Therapy
Intervention Description
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 hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment - Upper Extremity
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.
Time Frame
"Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.
Secondary Outcome Measure Information:
Title
Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks
Description
The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points
Time Frame
Change in AMAT score (points) from Baseline to 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Carter, MD, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurolutions
City
Santa Cruz
State/Province
California
ZIP/Postal Code
95060
Country
United States
Facility Name
Neurolutions
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28550098
Citation
Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
Results Reference
background
PubMed Identifier
29761128
Citation
Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.
Results Reference
background
PubMed Identifier
24136129
Citation
Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
Results Reference
background
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Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
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