Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sword Health, SA
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Number of correct movements
Overview
Brief Summary
The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.
The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.
The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;
- •persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)
- •more than 2 weeks after stroke onset;
- •the ability to sit comfortably for more than 10 minutes and perform two-step commands
Exclusion Criteria
- •no detectable motor deficits at baseline assessment;
- •severe aphasia;
- •clinical dementia or mini mental state examination (MMSE) below cutoff;
- •other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;
- •severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;
- •pain or deformity that limited upper limb movement on the affected side.
Outcomes
Primary Outcomes
Number of correct movements
Time Frame: At the end of each exercise session (4 minute duration)
Number of correct movements performed within the duration of each exercise session
Secondary Outcomes
- Number of incorrect repetitions(At the end of each exercise session (4 minute duration))
- Number of consecutive incorrect repetitions(At the end of each exercise session (4 minute duration))
- Total number of repetitions(At the end of each exercise session (4 minute duration))
- Posture errors(At the end of each exercise session (4 minute duration))
- Range of motion of correct movements(At the end of each exercise session (4 minute duration))
- Range of motion variability over time(Between the second and first minute; between the second and third minutes; between the third and fourth minute)
- Number of pauses(At the end of each exercise session (4 minute duration))
- Movement frequency(At the end of each exercise session (4 minute duration))