Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
NCT Number: NCT03995069
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29401-5703, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Practice generating grip force to the target shown on the computer screen in 3 dimensions.
Practice generating grip force to the target shown on the computer screen in 1 dimension.
Time frame: baseline to within 1 week post intervention
change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function
Time frame: baseline to within 1 week post intervention
a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function
Time frame: baseline to within 1 week post intervention
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
Time frame: baseline to 1 month post intervention
change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function
Time frame: baseline to 1 month post intervention
a clinical assessment for upper extremity function.
Time frame: baseline to 1 month post intervention
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
VA Office of Research and Development
Fed
Acronym: NEAD
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