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Stroke Wearable Operative Rehabilitation Device Impact Trial (SWORD-IT)

Primary Purpose

Ischemic Stroke, Upper Extremity Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Vibratory feedback and 3D movement analysis
Only 3D movement analysis
Sponsored by
Centro Hospitalar de Entre o Douro e Vouga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
  • Neurology Department, CHEDV
  • Rehabilitation Department, CHEDV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hand-to-mouth task - vibratory feedback

Hand-to-mouth task - no vibratory feedback

Arm Description

Hand-to-mouth task under vibratory feedback and 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis and provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed a vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.

Hand-to-mouth task in the same conditions as the experimental arm but without vibratory feedback, only 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis but does not provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed NO vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total number of movements
Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.
Range of motion in degrees
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.
Time between correct movements in seconds
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.
Cumulative amplitude of correct movements in degrees
Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task.
Cumulative amplitude of all movements performed in degrees
Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task.
Number of pause events during the 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.
Fatigue
Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue).
Pain
Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain).
Number and type of other distresses
Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring.

Full Information

First Posted
October 18, 2013
Last Updated
November 27, 2013
Sponsor
Centro Hospitalar de Entre o Douro e Vouga
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1. Study Identification

Unique Protocol Identification Number
NCT01967290
Brief Title
Stroke Wearable Operative Rehabilitation Device Impact Trial
Acronym
SWORD-IT
Official Title
Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar de Entre o Douro e Vouga

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Upper Extremity Hemiparesis
Keywords
stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand-to-mouth task - vibratory feedback
Arm Type
Experimental
Arm Description
Hand-to-mouth task under vibratory feedback and 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis and provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed a vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.
Arm Title
Hand-to-mouth task - no vibratory feedback
Arm Type
Active Comparator
Arm Description
Hand-to-mouth task in the same conditions as the experimental arm but without vibratory feedback, only 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis but does not provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed NO vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status.
Intervention Type
Device
Intervention Name(s)
Vibratory feedback and 3D movement analysis
Other Intervention Name(s)
Propriocetive actuation, Vibratory stimulation, SWORD, Stroke Wearable Operative Rehabilitation Device
Intervention Description
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Intervention Type
Device
Intervention Name(s)
Only 3D movement analysis
Other Intervention Name(s)
3D movement quantification, 3D movement characterization, SWORD, Stroke Wearable Operative Rehabilitation Device
Intervention Description
Hand-to-mouth task performed under 3D continuous movement analysis only
Primary Outcome Measure Information:
Title
Number of correct movements
Description
Number of correct movements performed within the duration of each hand-to-mouth task.
Time Frame
At the end of each hand-to-mouth task.
Secondary Outcome Measure Information:
Title
Total number of movements
Description
Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.
Time Frame
At the end of each hand-to-mouth task.
Title
Range of motion in degrees
Description
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.
Time Frame
At the end of each hand-to-mouth task.
Title
Time between correct movements in seconds
Description
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.
Time Frame
At the end of each hand-to-mouth task.
Title
Cumulative amplitude of correct movements in degrees
Description
Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task.
Time Frame
At the end of each hand-to-mouth task
Title
Cumulative amplitude of all movements performed in degrees
Description
Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task.
Time Frame
At the end of each hand-to-mouth task.
Title
Number of pause events during the task
Description
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.
Time Frame
At the end of each hand-to-mouth task
Title
Fatigue
Description
Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue).
Time Frame
At the end of each hand-to-mouth task.
Title
Pain
Description
Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain).
Time Frame
At the end of each hand-to-mouth task.
Title
Number and type of other distresses
Description
Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring.
Time Frame
At the end of each hand-to-mouth task.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vítor T. Cruz, MD
Organizational Affiliation
Centro Hospitalar de Entre o Douro e Vouga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Coutinho, PhD
Organizational Affiliation
IBMC - University of Oporto
Official's Role
Study Chair
Facility Information:
Facility Name
Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Neurology Department, CHEDV
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Rehabilitation Department, CHEDV
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
22672942
Citation
Bento VF, Cruz VT, Ribeiro DD, Cunha JP. The vibratory stimulus as a neurorehabilitation tool for stroke patients: proof of concept and tolerability test. NeuroRehabilitation. 2012;30(4):287-93. doi: 10.3233/NRE-2012-0757.
Results Reference
background
PubMed Identifier
22255572
Citation
Bento VF, Cruz VT, Ribeiro DD, Cunha JP. Towards a movement quantification system capable of automatic evaluation of upper limb motor function after neurological injury. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:5456-60. doi: 10.1109/IEMBS.2011.6091392.
Results Reference
background
PubMed Identifier
22942034
Citation
Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.
Results Reference
background
PubMed Identifier
23879761
Citation
Bento VF, Cruz VT, Ribeiro DD, Branco C, Coutinho P. The potential of motion quantification systems in the automatic evaluation of motor function after stroke. Int J Stroke. 2013 Aug;8(6):E37. doi: 10.1111/ijs.12111. No abstract available.
Results Reference
background
PubMed Identifier
25011667
Citation
Cruz VT, Bento V, Ruano L, Ribeiro DD, Fontao L, Mateus C, Barreto R, Colunas M, Alves A, Cruz B, Branco C, Rocha NP, Coutinho P. Motor task performance under vibratory feedback early poststroke: single center, randomized, cross-over, controlled clinical trial. Sci Rep. 2014 Jul 11;4:5670. doi: 10.1038/srep05670.
Results Reference
derived

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Stroke Wearable Operative Rehabilitation Device Impact Trial

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