Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NEAD)
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|ClinicalTrials.gov Identifier: NCT03995069|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: 3D Behavioral: 1D||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
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.
Practice generating grip force to the target shown on the computer screen in 1 dimension.
- Action Research Arm Test (ARAT) [ Time Frame: 3rd baseline to within 1 week post intervention ]a clinical assessment for upper extremity function
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995069
|Contact: Na Jin Seo, PhD MS BS||(843) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Na Jin Seo, PhD MS BS|
|Principal Investigator:||Na Jin Seo, PhD MS BS||Ralph H. Johnson VA Medical Center, Charleston, SC|