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Completed

NCT Number: NCT03032692

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMM - Murtosa, Murtosa, Aveiro District, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SWORD

Device

Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.

Other names: Stroke Wearable Operative Rehabilitation Device

Exercise with biofeedback

Other

exercise without biofeedback

Other

Primary outcomes

  1. 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

  1. Total number of repetitions

    Time frame: At the end of each exercise session (4 minute duration)

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

  2. Number of incorrect repetitions

    Time frame: At the end of each exercise session (4 minute duration)

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

  3. Number of consecutive incorrect repetitions

    Time frame: At the end of each exercise session (4 minute duration)

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

  4. Number of pauses

    Time frame: At the end of each exercise session (4 minute duration)

    Number of pauses registered during each exercise session

  5. Posture errors

    Time frame: At the end of each exercise session (4 minute duration)

    Number of posture errors registered during each exercise session

  6. Movement frequency

    Time frame: At the end of each exercise session (4 minute duration)

    Movement frequency (in Hertz) during each exercise session

  7. Range of motion of correct movements

    Time frame: At the end of each exercise session (4 minute duration)

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

  8. Range of motion variability over time

    Time frame: Between 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)

Sponsors and collaborators

Lead sponsor

Sword Health, SA

Industry

Collaborators

  • CMM - Centro Médico da Murtosa
  • CMM - Centro Médico de Aveiro
  • Centro Médico de Viseu

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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