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

Centro Hospitalar de Entre o Douro e Vouga

Status: Completed

Conditions: Upper Extremity Hemiparesis; Ischemic Stroke

Treatments: Device: Vibratory feedback and 3D movement analysis; Device: Only 3D movement analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01967290

PTDC/SAU-NEU/102075/2008_SWORD

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

Hand-to-mouth task - vibratory feedback

Experimental group

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.

Treatment:

Device: Vibratory feedback and 3D movement analysis

Hand-to-mouth task - no vibratory feedback

Active Comparator group

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.

Treatment:

Device: Only 3D movement analysis