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Completed

NCT Number: NCT01967290

Stroke Wearable Operative Rehabilitation Device Impact Trial

The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module.

The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time.

The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE, Guimarães, 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

  • More than 18 years old at stroke onset, with no superior age limit;
  • Medical diagnosis of acute ischemic stroke;
  • First ever stroke;
  • Previously independent, defined as having a modified Rankin scale (mRS) of 0-1;
  • Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion;
  • Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits >10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale;
  • Inpatients, within no more than 4 weeks after stroke onset;
  • Medically stable, no intravenous medication and already able to sit for more than one hour comfortably;
  • Favourable opinion of the attending stroke physician;
  • Patient and caregiver understand the purpose of the study and provided written informed consent.

Exclusion criteria

  • No detectable motor deficits at baseline assessment by the neurologist;
  • Severe aphasia;
  • Dementia (any stage);
  • Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks;
  • Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position;
  • Pain that limits upper limb movement either on the normal or affected side;
  • Upper limb amputation or severe deformity either on the normal or affected side;
  • Fixed articular limitations of upper limb either on the normal or affected side;
  • Enrollment in other trial in the previous 3 months.

Treatment and study plan

Vibratory feedback and 3D movement analysis

Device

Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.

Other names: Propriocetive actuation, Vibratory stimulation, SWORD, Stroke Wearable Operative Rehabilitation Device

Only 3D movement analysis

Device

Hand-to-mouth task performed under 3D continuous movement analysis only

Other names: 3D movement quantification, 3D movement characterization, SWORD, Stroke Wearable Operative Rehabilitation Device

Primary outcomes

  1. Number of correct movements

    Time frame: At the end of each hand-to-mouth task.

    Number of correct movements performed within the duration of each hand-to-mouth task.

Secondary outcomes

  1. Total number of movements

    Time frame: At the end of each hand-to-mouth task.

    Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.

  2. Range of motion in degrees

    Time frame: At the end of each hand-to-mouth task.

    Average, standard deviation and variance of the range of motion, measured in degrees, of all the correct movements performed during the duration of each hand-to-mouth task.

  3. Time between correct movements in seconds

    Time frame: At the end of each hand-to-mouth task.

    Average, standard deviation and variance of the time between correct movements, measured in seconds, of all the correct movements performed during the duration of each hand-to-mouth task.

  4. Cumulative amplitude of correct movements in degrees

    Time frame: At the end of each hand-to-mouth task

    Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task.

  5. Cumulative amplitude of all movements performed in degrees

    Time frame: At the end of each hand-to-mouth task.

    Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task.

  6. Number of pause events during the task

    Time frame: At the end of each hand-to-mouth task

    Number of episodes during the execution of each hand-to-mouth task where the patient stopped doing movements and/or the time between correct movements exceeded the mean plus one standard deviation measured within the same hand-to-mouth task.

  7. Fatigue

    Time frame: At the end of each hand-to-mouth task.

    Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue).

  8. Pain

    Time frame: At the end of each hand-to-mouth task.

    Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain).

  9. Number and type of other distresses

    Time frame: At the end of each hand-to-mouth task.

    Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar de Entre o Douro e Vouga

Other

Registry information

Official study title

Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period

Acronym: SWORD-IT

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2013
Registry last updated
Nov 28, 2013

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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