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出境医 / 临床实验 / Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NEAD)

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

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.

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.

Study Design
Layout table for study information
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
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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

Locations
Layout table for location information
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
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
Layout table for investigator information
Principal Investigator: Na Jin Seo, PhD MS BS Ralph H. Johnson VA Medical Center, Charleston, SC
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE October 28, 2020
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Action Research Arm Test (ARAT) [ Time Frame: 3rd baseline to within 1 week post intervention ]
a clinical assessment for upper extremity function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2019)
  • Box and Block Test [ Time Frame: 3rd baseline to within 1 week post intervention ]
    a clinical assessment for upper extremity function.
  • Force Direction [ Time Frame: 3rd baseline to within 1 week post intervention ]
    Angular deviation of the grip force vector from the target direction
  • Action Research Arm Test [ Time Frame: 3rd baseline to 1 month post intervention ]
    a clinical assessment for upper extremity function
  • Box and Block Test [ Time Frame: 3rd baseline to 1 month post intervention ]
    a clinical assessment for upper extremity function.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Official Title  ICMJE Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
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

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Behavioral: 3D
    Practice generating grip force to the target shown on the computer screen in 3 dimensions.
  • Behavioral: 1D
    Practice generating grip force to the target shown on the computer screen in 1 dimension.
Study Arms  ICMJE
  • Experimental: 3D
    The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
    Intervention: Behavioral: 3D
  • Active Comparator: 1D
    The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
    Intervention: Behavioral: 1D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Na Jin Seo, PhD MS BS (843) 792-0084 seon@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995069
Other Study ID Numbers  ICMJE A3066-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Na Jin Seo, PhD MS BS Ralph H. Johnson VA Medical Center, Charleston, SC
PRS Account VA Office of Research and Development
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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