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Clinical Trials/NCT01967290
NCT01967290
Completed
Not Applicable

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

Centro Hospitalar de Entre o Douro e Vouga3 sites in 1 country44 target enrollmentStarted: May 2013Last updated:
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ConditionsIschemic StrokeUpper Extremity Hemiparesis

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Centro Hospitalar de Entre o Douro e Vouga
Enrollment
44
Locations
3
Primary Endpoint
Number of correct movements
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Number of correct movements

Time Frame: At the end of each hand-to-mouth task.

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

Secondary Outcomes

  • 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)
  • Number of pause events during the task(At the end of each hand-to-mouth task)
  • 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.)
  • Cumulative amplitude of all movements performed in degrees(At the end of each hand-to-mouth task.)
  • Fatigue(At the end of each hand-to-mouth task.)
  • Pain(At the end of each hand-to-mouth task.)
  • Number and type of other distresses(At the end of each hand-to-mouth task.)

Investigators

Sponsor
Centro Hospitalar de Entre o Douro e Vouga
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vítor Tedim Cruz

MD

Centro Hospitalar de Entre o Douro e Vouga

Study Sites (3)

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