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Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

Not Applicable
Completed
Conditions
Ischemic Stroke
Upper Extremity Paresis
Registration Number
NCT03032692
Lead Sponsor
Sword Health, SA
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Number of correct movementsAt the end of each exercise session (4 minute duration)

Number of correct movements performed within the duration of each exercise session

Secondary Outcome Measures
NameTimeMethod
Number of incorrect repetitionsAt the end of each exercise session (4 minute duration)

Number of incorrect repetitions performed within the duration of each exercise session

Number of consecutive incorrect repetitionsAt the end of each exercise session (4 minute duration)

Number of consecutive incorrect repetitions performed within the duration of each exercise session

Total number of repetitionsAt the end of each exercise session (4 minute duration)

Total number of repetitions performed within the duration of each exercise session

Range of motion of correct movementsAt the end of each exercise session (4 minute duration)

Mean range of motion of the correct movements performed during each exercise session

Range of motion variability over timeBetween the second and first minute; between the second and third minutes; between the third and fourth minute

Variability of the mean range of motion during the exercise session (for correct movements)

Number of pausesAt the end of each exercise session (4 minute duration)

Number of pauses registered during each exercise session

Posture errorsAt the end of each exercise session (4 minute duration)

Number of posture errors registered during each exercise session

Movement frequencyAt the end of each exercise session (4 minute duration)

Movement frequency (in Hertz) during each exercise session

Trial Locations

Locations (3)

CMM - Murtosa

🇵🇹

Murtosa, Aveiro, Portugal

CMM - Centro Médico de Aveiro

🇵🇹

Aveiro, Portugal

CMM- Centro Médico de Viseu

🇵🇹

Viseu, Portugal

CMM - Murtosa
🇵🇹Murtosa, Aveiro, Portugal

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