NCT02912923

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

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 Sep 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

September 14, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2016

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

September 14, 2016

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+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.

    Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition)

Secondary Outcomes (6)

  • Fugl-Meyer Upper Extremity Assessment

    Baseline

  • Reaching Performance Scale

    Baseline

  • Post-Test Questionnaire

    1 day (at the end of study session)

  • Body joint's position data

    Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition)

  • Hands' position data from the robotic devices

    Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition)

  • +1 more secondary outcomes

Study Arms (2)

Start with Visual + Force

EXPERIMENTAL

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 FeedbackOther: Visual + Force + Game Scores Feedback

Start with Visual + Force + Game Scores

EXPERIMENTAL

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 FeedbackOther: Visual + Force + Game Scores Feedback

Interventions

Visual + Force FeedbackOTHER

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.

Start with Visual + ForceStart with Visual + Force + Game Scores
Visual + Force + Game Scores FeedbackOTHER

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.

Start with Visual + ForceStart with Visual + Force + Game Scores

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 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.

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
  • Severe uncorrected visual impairment that could prevent participants from completing the task

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, Van der Loos HFM. Biofeedback vs. game scores for reducing trunk compensation after stroke: a randomized crossover trial. Top Stroke Rehabil. 2018 Mar;25(2):96-113. doi: 10.1080/10749357.2017.1394633. Epub 2017 Oct 27.

    PMID: 29078743DERIVED

Related Links

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

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

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

September 14, 2016

First Posted

September 23, 2016

Study Start

September 14, 2016

Primary Completion

December 8, 2016

Study Completion

December 8, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)