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Reaching in Stroke 3rd Phase (RISP3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912923
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Networks of Centres of Excellence of Canada
Natural Sciences and Engineering Research Council, Canada
UBC Faculty of Graduate and Postdoctoral Studies
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) and rewards (game scores), on their upper limb reaching patterns and trunk compensatory movements

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

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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, 3rd Phase
Actual Study Start Date : September 14, 2016
Actual Primary Completion Date : December 8, 2016
Actual Study Completion Date : December 8, 2016

Arm Intervention/treatment
Experimental: Start with Visual + Force
Participants will complete a set of trials while receiving Visual + Force Feedback. After finishing, participants will continue to a new set of trials while receiving Visual + Force + Game Scores Feedback.
Other: Visual + Force Feedback

Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.

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. The magnitude of the cue will be proportional to the magnitude of trunk compensation.


Other: Visual + Force + Game Scores Feedback

Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.

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. The magnitude of the cue will be proportional to the magnitude of trunk compensation.

Game Scores- Numerical score displayed next to the cursors. The participant will be rewarded with more points when less compensation is exhibited, or with less points when an increased level of compensation is measured.


Experimental: Start with Visual + Force + Game Scores
Participants will complete a set of trials while receiving Visual + Force + Game Scores Feedback. After finishing, participants will continue to a new set of trials while receiving Visual + Force Feedback.
Other: Visual + Force Feedback

Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.

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. The magnitude of the cue will be proportional to the magnitude of trunk compensation.


Other: Visual + Force + Game Scores Feedback

Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a "normal" error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.

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. The magnitude of the cue will be proportional to the magnitude of trunk compensation.

Game Scores- Numerical score displayed next to the cursors. The participant will be rewarded with more points when less compensation is exhibited, or with less points when an increased level of compensation is measured.





Primary Outcome Measures :
  1. Change in Anterior Trunk Displacement [ Time Frame: Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd 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+force feedback, post visual+force feedback (no feedback), visual+force+game scores feedback, and post visual+force+game scores 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. Body joint's position data [ Time Frame: Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition) ]
    Three dimensional position in millimeters of the body joints captured by the motion tracking camera while participants reach forward.

  5. Hands' position data from the robotic devices [ Time Frame: Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition) ]
    Three dimensional position in millimeters of the participants' hands captured by the robotic devices while participants reach forward.

  6. Time to complete reach [ Time Frame: up to 30 seconds ]
    Duration in seconds of the participants' reaching movements. Three dimensional position in millimeters of the body joints captured by the motion tracking camera while participants reach forward.



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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 OK if they use their trunk to help themselves, and from that point of flexion moving it forward (without touching their thigh) to touch their knee (on the same side as the weak arm). They 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
  • Severe uncorrected visual impairment that could prevent participants from completing the task

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): NCT02912923


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Sponsors and Collaborators
University of British Columbia
Networks of Centres of Excellence of Canada
Natural Sciences and Engineering Research Council, Canada
UBC Faculty of Graduate and Postdoctoral Studies
Investigators
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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):
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Responsible Party: Hendrik F. Machiel Van der Loos, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02912923    
Other Study ID Numbers: H14-01485
First Posted: September 23, 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:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases