Stroke Wearable Operative Rehabilitation Device Impact Trial

NCT01967290 | Completed

• 1 other identifier: PTDC/SAU-NEU/102075/2008_SWORD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Ischemic Stroke; Upper Extremity Hemiparesis

Keywords

stroke; motor deficits; motor rehabilitation; neurorehabilitation; medical devices; wearable devices; e-health systems

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Total number of movements

  At the end of each hand-to-mouth task.

• Range of motion in degrees

  At the end of each hand-to-mouth task.

• Time between correct movements in seconds

  At the end of each hand-to-mouth task.

• Cumulative amplitude of correct movements in degrees

  At the end of each hand-to-mouth task

• Cumulative amplitude of all movements performed in degrees

  At the end of each hand-to-mouth task.

Study Arms (2)

Hand-to-mouth task - vibratory feedback

EXPERIMENTAL

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.

Device: Vibratory feedback and 3D movement analysis

Hand-to-mouth task - no vibratory feedback

ACTIVE COMPARATOR

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.

Device: Only 3D movement analysis

Interventions

Vibratory feedback and 3D movement analysis DEVICE

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

Also known as: Propriocetive actuation, Vibratory stimulation, SWORD, Stroke Wearable Operative Rehabilitation Device

Hand-to-mouth task - vibratory feedback

Only 3D movement analysis DEVICE

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

Also known as: 3D movement quantification, 3D movement characterization, SWORD, Stroke Wearable Operative Rehabilitation Device

Hand-to-mouth task - no vibratory feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar de Entre o Douro e Vouga: lead

Study Sites (3)

Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE

Guimarães, 4835-044, Portugal

Location

Neurology Department, CHEDV

Santa Maria da Feira, 4520-211, Portugal

Location

Rehabilitation Department, CHEDV

Santa Maria da Feira, 4520-211, Portugal

Location

Related Publications (5)

• 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.

  PMID: 22672942 BACKGROUND

• 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.

  PMID: 22255572 BACKGROUND

• Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.

  PMID: 22942034 BACKGROUND

• 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.

  PMID: 23879761 BACKGROUND

• 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.

  PMID: 25011667 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vítor T. Cruz, MD

  Centro Hospitalar de Entre o Douro e Vouga

  PRINCIPAL INVESTIGATOR

• Paula Coutinho, PhD

  IBMC - University of Oporto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 22, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

PT (3)