Clinical trial NCT01967290: Stroke Wearable Operative Rehabilitation Device Impact Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Upper Extremity Hemiparesis
Keywords: stroke
motor deficits
motor rehabilitation
neurorehabilitation
medical devices
wearable devices
e-health systems
Lead sponsor: Centro Hospitalar de Entre o Douro e Vouga
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of correct movements
timeFrame: At the end of each hand-to-mouth task.
Secondary outcomes:
measure: Total number of movements
timeFrame: At the end of each hand-to-mouth task.
measure: Range of motion in degrees
timeFrame: At the end of each hand-to-mouth task.
measure: Time between correct movements in seconds
timeFrame: At the end of each hand-to-mouth task.
measure: Cumulative amplitude of correct movements in degrees
timeFrame: At the end of each hand-to-mouth task
measure: Cumulative amplitude of all movements performed in degrees
timeFrame: At the end of each hand-to-mouth task.
measure: Number of pause events during the task
timeFrame: At the end of each hand-to-mouth task
measure: Fatigue
timeFrame: At the end of each hand-to-mouth task.
measure: Pain
timeFrame: At the end of each hand-to-mouth task.
measure: Number and type of other distresses
timeFrame: At the end of each hand-to-mouth task.
Other outcomes:
Locations:
city: Guimarães
country: Portugal
facility: Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
city: Santa Maria da Feira
country: Portugal
facility: Neurology Department, CHEDV
city: Santa Maria da Feira
country: Portugal
facility: Rehabilitation Department, CHEDV
Study officials:
affiliation: Centro Hospitalar de Entre o Douro e Vouga
name: Vítor T. Cruz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IBMC - University of Oporto
name: Paula Coutinho, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.
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.
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.