NCT02654951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

December 22, 2015

Last Update Submit

March 30, 2017

Conditions

Stroke

Keywords

StrokeRehabilitation RoboticsBimanualCompensatory movementsHemiplegiaKinematicsReachingTrunk

Outcome Measures

Primary Outcomes (1)

  • Change in Anterior Trunk Displacement

    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.

    Baseline, 1 hour (after completing force feedback condition) and 2 hours (after completing visual feedback condition)

Secondary Outcomes (4)

  • Fugl-Meyer Upper Extremity Assessment

    Baseline

  • Reaching Performance Scale

    Baseline

  • Post-Test Questionnaire

    1 day (at the end of study session)

  • Motion data logs from the motion tracking camera and the robots

    Baseline, 1 hour (after completing force feedback condition) and 2 hours (after completing visual feedback condition)

Study Arms (2)

Visual + Force Feedback

EXPERIMENTAL

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 FeedbackOther: Force Feedback

Force + Visual Feedback

EXPERIMENTAL

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 FeedbackOther: Force Feedback

Interventions

Visual FeedbackOTHER

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.

Force + Visual FeedbackVisual + Force Feedback
Force FeedbackOTHER

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.

Force + Visual FeedbackVisual + Force Feedback

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

  • Valdes BA, Schneider AN, Van der Loos HFM. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities. Arch Phys Med Rehabil. 2017 Oct;98(10):1932-1940. doi: 10.1016/j.apmr.2017.03.034. Epub 2017 May 17.

    PMID: 28526482DERIVED

Related Links

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • Machiel Van Der Loos, PhD

    The University of British Columbia- Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 13, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)