Stroke Wearable Operative Rehabilitation Device Impact Trial

Ischemic Stroke Clinical Trial

— SWORD-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967290
• Other study ID #: PTDC/SAU-NEU/102075/2008_SWORD
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: November 27, 2013
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Centro Hospitalar de Entre o Douro e Vouga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Data Protection AgencyPortugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Upper Extremity Hemiparesis

Intervention

Device:
• Vibratory feedback and 3D movement analysis
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
• Only 3D movement analysis
Hand-to-mouth task performed under 3D continuous movement analysis only

Locations

Country	Name	City	State
Portugal	Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE	Guimarães
Portugal	Neurology Department, CHEDV	Santa Maria da Feira
Portugal	Rehabilitation Department, CHEDV	Santa Maria da Feira

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar de Entre o Douro e Vouga

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

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. — View Citation

Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81. — View 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. — View 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. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:5456-60. doi: 10.1109/IEMBS.2011.6091392. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of correct movements	Number of correct movements performed within the duration of each hand-to-mouth task.	At the end of each hand-to-mouth task.	No
Secondary	Total number of movements	Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.	At the end of each hand-to-mouth task.	No
Secondary	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.	At the end of each hand-to-mouth task.	No
Secondary	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.	At the end of each hand-to-mouth task.	No
Secondary	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.	At the end of each hand-to-mouth task	No
Secondary	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.	At the end of each hand-to-mouth task.	No
Secondary	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.	At the end of each hand-to-mouth task	No
Secondary	Fatigue	Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue).	At the end of each hand-to-mouth task.	Yes
Secondary	Pain	Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain).	At the end of each hand-to-mouth task.	Yes
Secondary	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.	At the end of each hand-to-mouth task.	Yes