Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke

Not Applicable

Completed

Conditions: Stroke

Interventions: Behavioral: 3D
Behavioral: 1D

Registration Number: NCT03995069

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D	3D	The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
1D	1D	The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	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

Secondary Outcome Measures