Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

Ischemic Stroke Clinical Trial

Official title:

Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032692
• Other study ID #: RCT-BFK01
• Status: Completed
• Phase: N/A
• First received: January 24, 2017
• Last updated: June 12, 2017
• Start date: June 1, 2016
• Est. completion date: August 31, 2016

Study information

• Verified date: June 2017
• Source: Sword Health, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.

The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.

The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;

• persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)

• more than 2 weeks after stroke onset;

• the ability to sit comfortably for more than 10 minutes and perform two-step commands

Exclusion Criteria:

• no detectable motor deficits at baseline assessment;

• severe aphasia;

• clinical dementia or mini mental state examination (MMSE) below cutoff;

• other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;

• severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;

• pain or deformity that limited upper limb movement on the affected side.

Related Conditions & MeSH terms

• Ischemic Stroke
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

Device:
• SWORD
Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.

Other:
• Exercise with biofeedback

• exercise without biofeedback

Locations

Country	Name	City	State
Portugal	CMM - Centro Médico de Aveiro	Aveiro
Portugal	CMM - Murtosa	Murtosa	Aveiro
Portugal	CMM- Centro Médico de Viseu	Viseu

Sponsors (4)

Lead Sponsor	Collaborator
Sword Health, SA	Centro Médico de Viseu, CMM - Centro Médico da Murtosa, CMM - Centro Médico de Aveiro

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of correct movements	Number of correct movements performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Total number of repetitions	Total number of repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Number of incorrect repetitions	Number of incorrect repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Number of consecutive incorrect repetitions	Number of consecutive incorrect repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Number of pauses	Number of pauses registered during each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Posture errors	Number of posture errors registered during each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Movement frequency	Movement frequency (in Hertz) during each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Range of motion of correct movements	Mean range of motion of the correct movements performed during each exercise session	At the end of each exercise session (4 minute duration)
Secondary	Range of motion variability over time	Variability of the mean range of motion during the exercise session (for correct movements)	Between the second and first minute; between the second and third minutes; between the third and fourth minute