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

NCT03032692 | Completed

• 1 other identifier: RCT-BFK01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ischemic Stroke; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total number of repetitions

  At the end of each exercise session (4 minute duration)

• Number of incorrect repetitions

  At the end of each exercise session (4 minute duration)

• Number of consecutive incorrect repetitions

  At the end of each exercise session (4 minute duration)

• Number of pauses

  At the end of each exercise session (4 minute duration)

• Posture errors

  At the end of each exercise session (4 minute duration)

Study Arms (2)

SWORD and exercise with biofeedback

EXPERIMENTAL

The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement.

Device: SWORD; Other: Exercise with biofeedback

SWORD and exercise without biofeedback

ACTIVE COMPARATOR

The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient.

Device: SWORD; Other: exercise without biofeedback

Interventions

SWORD DEVICE

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.

Also known as: Stroke Wearable Operative Rehabilitation Device

SWORD and exercise with biofeedback; SWORD and exercise without biofeedback

Exercise with biofeedback OTHER

SWORD and exercise with biofeedback

exercise without biofeedback OTHER

SWORD and exercise without biofeedback

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sword Health, SA: lead
• CMM - Centro Médico da Murtosa: collaborator
• CMM - Centro Médico de Aveiro: collaborator
• Centro Médico de Viseu: collaborator

Study Sites (3)

CMM - Murtosa

Murtosa, Aveiro District, 3870-216, Portugal

Location

CMM - Centro Médico de Aveiro

Aveiro, Portugal

Location

CMM- Centro Médico de Viseu

Viseu, 3500-719, Portugal

Location

MeSH Terms

Conditions

Ischemic Stroke; Paresis

Interventions

Exercise; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Fernando D Correia, MD

  Sword Health, SA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: June 1, 2016
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)