Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NEAD)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D
1D
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hand Strength, Electromyography
Eligibility Criteria
Inclusion Criteria:
- Survived a stroke at least 3 months ago
- Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4)
- Ability to generate palpable volitional grip force upon cue
- Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)
- Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)
Exclusion Criteria:
- Concurrent upper limb rehabilitation
- Inability to follow 2-step commands
- Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5)
- Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
- Total sensory loss on fingertips (NIHSS Sensory score=2)
- Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions)
- Language barrier or cognitive impairment that precludes providing consent
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D
1D
Arm Description
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
Outcomes
Primary Outcome Measures
Action Research Arm Test (ARAT)
a clinical assessment for upper extremity function
Secondary Outcome Measures
Full Information
NCT ID
NCT03995069
First Posted
June 19, 2019
Last Updated
February 8, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03995069
Brief Title
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Acronym
NEAD
Official Title
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.
Detailed Description
Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.
Stroke survivors with moderate to severe hand impairment with at least palpable volitional grip force will randomly be assigned to either the experimental or control group, stratified by impairment level. Both groups will undergo 3 1-hr training sessions per week for 6 weeks in which they practice volitional finger force generation against force sensors. The experimental group will practice for various target force directions to explore the 3D force workspace and receive feedback in 3D force, while the control group will practice 1D force generation without feedback on other directional forces on a computer screen.
Training will progress by increasing influence of flexion synergy by varying posture requirements and increasing force level, introducing feedback delay, and incorporating unilateral/bilateral activity. Evaluation will occur at baseline (3 times over 3 weeks to establish baseline trends) and every 2 weeks during 6-week intervention to determine pattern of progress, and at 1-month follow-up to assess retention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hand Strength, Electromyography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D
Arm Type
Experimental
Arm Description
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
Arm Title
1D
Arm Type
Active Comparator
Arm Description
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
Intervention Type
Behavioral
Intervention Name(s)
3D
Intervention Description
Practice generating grip force to the target shown on the computer screen in 3 dimensions.
Intervention Type
Behavioral
Intervention Name(s)
1D
Intervention Description
Practice generating grip force to the target shown on the computer screen in 1 dimension.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
a clinical assessment for upper extremity function
Time Frame
3rd baseline to within 1 week post intervention
Other Pre-specified Outcome Measures:
Title
Box and Block Test
Description
a clinical assessment for upper extremity function.
Time Frame
3rd baseline to within 1 week post intervention
Title
Force Direction
Description
Angular deviation of the grip force vector from the target direction
Time Frame
3rd baseline to within 1 week post intervention
Title
Action Research Arm Test
Description
a clinical assessment for upper extremity function
Time Frame
3rd baseline to 1 month post intervention
Title
Box and Block Test
Description
a clinical assessment for upper extremity function.
Time Frame
3rd baseline to 1 month post intervention
Title
Force Direction
Description
Angular deviation of the grip force vector from the target direction
Time Frame
baseline to 1 month post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Survived a stroke at least 3 months ago
Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4)
Ability to generate palpable volitional grip force upon cue
Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)
Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)
Exclusion Criteria:
Concurrent upper limb rehabilitation
Inability to follow 2-step commands
Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5)
Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
Total sensory loss on fingertips (NIHSS Sensory score=2)
Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions)
Language barrier or cognitive impairment that precludes providing consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na Jin Seo, PhD MS BS
Phone
(843) 792-0084
Email
NaJin.Seo@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutha A LaRue
Phone
843-789-6707
Email
Rutha.Larue@va.gov
First Name & Middle Initial & Last Name & Degree
Sarah A Jackson, BA MA
Phone
(843) 789-6700
Email
sarah.jackson@va.gov
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual data will be shared as a supplement of a publication in peer reviewed journals if allowed by the journal, and also upon written request.
IPD Sharing Time Frame
During the study period and 5 years post study completion
Citations:
PubMed Identifier
35413931
Citation
Seo NJ, Kamper DG, Ramakrishnan V, Harvey JB, Finetto C, Schranz C, Scronce G, Coupland K, Howard K, Blaschke J, Baker A, Meinzer C, Velozo CA, Adams RJ. Effect of novel training to normalize altered finger force direction post-stroke: study protocol for a double-blind randomized controlled trial. Trials. 2022 Apr 12;23(1):301. doi: 10.1186/s13063-022-06224-w.
Results Reference
derived
Learn more about this trial
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
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