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Reaching in Stroke

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ClinicalTrials.gov Identifier: NCT02654951
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
UBC Peter Wall Institute for Advanced Studies
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Hendrik F. Machiel Van der Loos, University of British Columbia

Brief Summary:
The project targets stroke survivors to investigate the effect of augmented feedback (using robotic force cues and visual feedback) on their upper limb reaching patterns and trunk compensatory movements.

Condition or disease Intervention/treatment Phase
Stroke Other: Visual Feedback Other: Force Feedback Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reducing Compensatory Movements in Stroke Therapy Through the Use of Robotic Devices and Augmented Feedback
Study Start Date : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Visual + Force Feedback
Participants will complete a set of trials while receiving visual feedback only. After finishing, participants will continue to a new set of trials while receiving force feedback only.
Other: Visual Feedback

The visual feedback condition will use a monitor to display two cursors (empty circles) that will represent the participant's hands, and the circles will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of red ink will increase proportionally to the magnitude of trunk compensation.

The goal of the participants will be to move their hands/cursors towards a target, while keeping the cursors as empty as possible.


Other: Force Feedback

A monitor will display the same cursors as in the visual feedback condition, however, the cursors will be completely empty and will not fill with color.

The force feedback cues will be provided as resistance to move the robots' handles. These cues will be applied when the user moves outside a "normal" error band. In addition, the magnitude of the cue will be proportional to the magnitude of trunk compensation.

The goal of the participants will be to move their hands/cursors towards a target, while moving the robots with the least resistance possible.


Experimental: Force + Visual Feedback
Participants will complete a set of trials while receiving force feedback only. After finishing, participants will continue to a new set of trials while receiving visual feedback only.
Other: Visual Feedback

The visual feedback condition will use a monitor to display two cursors (empty circles) that will represent the participant's hands, and the circles will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of red ink will increase proportionally to the magnitude of trunk compensation.

The goal of the participants will be to move their hands/cursors towards a target, while keeping the cursors as empty as possible.


Other: Force Feedback

A monitor will display the same cursors as in the visual feedback condition, however, the cursors will be completely empty and will not fill with color.

The force feedback cues will be provided as resistance to move the robots' handles. These cues will be applied when the user moves outside a "normal" error band. In addition, the magnitude of the cue will be proportional to the magnitude of trunk compensation.

The goal of the participants will be to move their hands/cursors towards a target, while moving the robots with the least resistance possible.





Primary Outcome Measures :
  1. Change in Anterior Trunk Displacement [ Time Frame: Baseline, 1 hour (after completing force feedback condition) and 2 hours (after completing visual feedback condition) ]
    This movement is defined as the displacement of the "spine shoulder" joint of the Kinect skeleton in the Z (depth) direction.The average of the magnitude of the anterior trunk displacement will be taken during the baseline (no feedback), visual feedback, post visual feedback (no feedback), force feedback, and post force feedback (no feedback) conditions, to assess if there is any change in the amount of trunk compensation employed by participants.


Secondary Outcome Measures :
  1. Fugl-Meyer Upper Extremity Assessment [ Time Frame: Baseline ]
  2. Reaching Performance Scale [ Time Frame: Baseline ]
  3. Post-Test Questionnaire [ Time Frame: 1 day (at the end of study session) ]
    A questionnaire that includes Likert questions to investigate the usability of the system and the experience of the user with the two feedback types.

  4. Motion data logs from the motion tracking camera and the robots [ Time Frame: Baseline, 1 hour (after completing force feedback condition) and 2 hours (after completing visual feedback condition) ]
    Kinematic data from the different joints of the participants' bodies, and the duration of every reach.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 19 years old
  • Hemiplegia as a result of a non-traumatic cerebral stroke (ischaemic or hemorrhagic)
  • Stroke occurred at least 3 months prior to study
  • Ability to understand/follow directions and answer questions in English
  • Ability to maintain a sitting position in a standard office chair without arm rests, independently or with minimal supervision, for 1.5 hours.
  • Have the ability to perform the following movement several times with their weak arm (while seated): move their hand to their hip (on the same side as the weak arm), it's acceptable if participants use their trunk to help themselves, and from that point of flexion moving the hand forward (without touching their thigh) to touch their knee (on the same side as the weak arm). Participants should be able to do this movement without any help from their strong hand.

Exclusion Criteria:

  • Upper limb orthopaedic surgery in the past 3 months
  • Shoulder subluxation or significant shoulder pain
  • Trunk pain
  • Other orthopaedic or neurological conditions affecting the arm or trunk
  • Uncorrected visual impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654951


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Sponsors and Collaborators
University of British Columbia
UBC Peter Wall Institute for Advanced Studies
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Machiel Van Der Loos, PhD The University of British Columbia- Associate Professor

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hendrik F. Machiel Van der Loos, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02654951     History of Changes
Other Study ID Numbers: H14-01485-A004
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hendrik F. Machiel Van der Loos, University of British Columbia:
Stroke
Rehabilitation Robotics
Bimanual
Compensatory movements
Hemiplegia
Kinematics
Reaching
Trunk

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases