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Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995069
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: 3D Behavioral: 1D Not Applicable

Detailed Description:

Currently can't recruit due to COVID-19

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Arm Intervention/treatment
Experimental: 3D
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
Behavioral: 3D
Practice generating grip force to the target shown on the computer screen in 3 dimensions.

Active Comparator: 1D
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
Behavioral: 1D
Practice generating grip force to the target shown on the computer screen in 1 dimension.




Primary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: 3rd baseline to within 1 week post intervention ]
    a clinical assessment for upper extremity function


Other Outcome Measures:
  1. Box and Block Test [ Time Frame: 3rd baseline to within 1 week post intervention ]
    a clinical assessment for upper extremity function.

  2. Force Direction [ Time Frame: 3rd baseline to within 1 week post intervention ]
    Angular deviation of the grip force vector from the target direction

  3. Action Research Arm Test [ Time Frame: 3rd baseline to 1 month post intervention ]
    a clinical assessment for upper extremity function

  4. Box and Block Test [ Time Frame: 3rd baseline to 1 month post intervention ]
    a clinical assessment for upper extremity function.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Survived a stroke 3 to 9 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995069


Contacts
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Contact: Na Jin Seo, PhD MS BS (843) 792-0084 seon@musc.edu

Locations
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United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Contact: Rutha A LaRue    843-789-6707    Rutha.Larue@va.gov   
Contact: Sarah A Jackson, BA MA    (843) 789-6700    sarah.jackson@va.gov   
Principal Investigator: Na Jin Seo, PhD MS BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Na Jin Seo, PhD MS BS Ralph H. Johnson VA Medical Center, Charleston, SC
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03995069    
Obsolete Identifiers: NCT03993756
Other Study ID Numbers: A3066-R
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: During the study period and 5 years post study completion

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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
Keywords provided by VA Office of Research and Development:
Hand Strength
Electromyography
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases