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Functional Engagement in Assisted Therapy Through Exercise Robotics (FEATHERS)

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ClinicalTrials.gov Identifier: NCT02290353
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
UBC Peter Wall Institute for Advanced Studies
Information provided by (Responsible Party):
Hendrik F. Machiel Van der Loos, University of British Columbia

Brief Summary:
The investigators have assembled an integrated knowledge/technology/client team to develop a novel motion capture-based home therapy program for children with hemiparesis (cerebral palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society needs new approaches to improve the quality of life for millions of Canadians. The method proposaed here is to combine low-cost motion capture devices, a bimanual training program, social media frameworks such as Facebook Games, and on-line performance sharing between therapy clients and with their therapists. The investigators believe that together these approaches will yield interventions for people with stroke and children with hemiplegia that significantly improve their motivation to continue their exercise programs and thus improve their functional ability which will lead to improved quality of life.

Condition or disease Intervention/treatment Phase
Stroke Cerebral Palsy Traumatic Brain Injury Device: FEATHERS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Engagement in Assisted Therapy Through Exercise Robotics
Actual Study Start Date : April 2015
Actual Primary Completion Date : November 16, 2015
Actual Study Completion Date : November 16, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adult (Stroke) group
This includes early intervention and late intervention sub-groups. Intervention: FEATHERS Device
Device: FEATHERS

FEATHERS Device includes a camera (PS3 Eye), 2 modified PS3 Move controllers, and a computer [2]. A software is designed to search through the camera feed to find the glowing balls attached to PS3 Move controllers, and changes the position of the computer's mouse cursor based on the balls' position. The participants play simple Facebook games that involve point-and-click by using the Move controllers and moving their arms in space to control the cursor and play games.

During the 8 weeks of intervention, we ask the participants to use the FEATHERS device to play online games (and thus do exercise) on the FEATHERS Facebook app at least 5 days/week, and at least 30 minutes/day. We are interested in seeing how this type of exercise changes the functional clinical scores of the participants.


Experimental: Teenagers (Cerebral Palsy) group
This includes early intervention and late intervention sub-groups. Intervention: FEATHERS Device
Device: FEATHERS

FEATHERS Device includes a camera (PS3 Eye), 2 modified PS3 Move controllers, and a computer [2]. A software is designed to search through the camera feed to find the glowing balls attached to PS3 Move controllers, and changes the position of the computer's mouse cursor based on the balls' position. The participants play simple Facebook games that involve point-and-click by using the Move controllers and moving their arms in space to control the cursor and play games.

During the 8 weeks of intervention, we ask the participants to use the FEATHERS device to play online games (and thus do exercise) on the FEATHERS Facebook app at least 5 days/week, and at least 30 minutes/day. We are interested in seeing how this type of exercise changes the functional clinical scores of the participants.





Primary Outcome Measures :
  1. Wolf Motor Function Test WMFT [ Time Frame: every 2 month, from date of randomization (month 0) to the end of the study (end of month 6) ]

    For early intervention group: administer at enrollment in the study (baseline), at the end of FEATHERS intervention (end of week 8, assessing changes due to intervention), at the end of week 16 (no intervention period, retention), at the end of week 24 (no intervention period, assessing variation of the outcomes even without a therapy intervention).

    For late intervention group: administer at enrollment in the study (baseline), at the end of week 8 (no intervention period, assessing variation of the outcomes even without a therapy intervention), at the end of FEATHERS intervention (end of week 16, assessing changes due to intervention), at the end of week 24 (no intervention period, retention).

    Administer for all participants.



Secondary Outcome Measures :
  1. Motricity index, grip/pinch index [ Time Frame: every 2 month, from date of randomization (month 0) to the end of the study (end of month 6) ]

    For early intervention group: administer at enrollment in the study (baseline), at the end of FEATHERS intervention (end of week 8, assessing changes due to intervention), at the end of week 16 (no intervention period, retention), at the end of week 24 (no intervention period, assessing variation of the outcomes even without a therapy intervention).

    For late intervention group: administer at enrollment in the study (baseline), at the end of week 8 (no intervention period, assessing variation of the outcomes even without a therapy intervention), at the end of FEATHERS intervention (end of week 16, assessing changes due to intervention), at the end of week 24 (no intervention period, retention).

    Administer for all participants.


  2. Canadian Occupational Performance Measure COPM [ Time Frame: every 2 month, from date of randomization (month 0) to the end of the study (end of month 6) ]

    For early intervention group: administer at enrollment in the study (baseline), at the end of FEATHERS intervention (end of week 8, assessing changes due to intervention), at the end of week 16 (no intervention period, retention), at the end of week 24 (no intervention period, assessing variation of the outcomes even without a therapy intervention).

    For late intervention group: administer at enrollment in the study (baseline), at the end of week 8 (no intervention period, assessing variation of the outcomes even without a therapy intervention), at the end of FEATHERS intervention (end of week 16, assessing changes due to intervention), at the end of week 24 (no intervention period, retention).

    Administer for all participants.


  3. Confidence scale [ Time Frame: one time only, at the beginning of FEAHTERS intervention ]

    Administer at the beginning of the FEATHERS intervention, after participant has received training on how to use the FEATHERS technology (beginning of week 1 for the early intervention group and beginning of week 9 for the late intervention group).

    Administer for all participants.


  4. Paediatric Motivation Scale [ Time Frame: every 2 weeks (during the 2 months of FEATHERS intervention) ]

    This is built in the FEATHERS technology to prompt the participants to self-administer the questionnaire. This will be during the FEATHERS intervention period (weeks 1-8 for the early intervention group and weeks 9-16 for the late intervention group). It will be administered every two weeks, at the end of the week. Participants are randomly assigned to receive the test either at the end of the odd weeks or the even weeks.

    Administer for all participants.


  5. Usability of the System [ Time Frame: one time only, at the end of FEATHERS intervention ]

    Administer at the end of FEATHERS intervention period (end of week 8 for the early intervention group and end of week 16 for the late intervention group).

    Administer for all participants.


  6. Modified Rankin Test [ Time Frame: one time only, at the beginning of the study ]
    administer at enrollment in the study

  7. Reach Performance Scale [ Time Frame: every 2 month, from date of randomization (month 0) to the end of the study (end of month 6) ]

    For early intervention group: administer at enrollment in the study (baseline), at the end of FEATHERS intervention (end of week 8, assessing changes due to intervention), at the end of week 16 (no intervention period, retention), at the end of week 24 (no intervention period, assessing variation of the outcomes even without a therapy intervention).

    For late intervention group: administer at enrollment in the study (baseline), at the end of week 8 (no intervention period, assessing variation of the outcomes even without a therapy intervention), at the end of FEATHERS intervention (end of week 16, assessing changes due to intervention), at the end of week 24 (no intervention period, retention).

    Administer for all participants.


  8. Game-based kinematic test [ Time Frame: every 2 weeks (during the 2 months of FEATHERS intervention) ]

    This is built in the FEATHERS technology to prompt the participants to self-administer the test. This will be during the FEATHERS intervention period (weeks 1-8 for the early intervention group and weeks 9-16 for the late intervention group). It will be administered every two weeks, at the end of the week. Participants are randomly assigned to receive the test either at the end of the odd weeks or the even weeks.

    Administer for all participants.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion for adolescents:

  • Ages 13-18 years
  • Hemiplegia
  • Gross Motor Functional Classification System (GMFCS) Level 1-4
  • Manual Ability Classification System (MACS) Level 1-3
  • Grade 2+ bilateral shoulder flexors (ability to lift arms against gravity at least some distance)
  • The ability to follow instructions and answer questions in English (as determined by referring therapist and caregiver)
  • Not had orthopedic surgery in the past 6 months

Inclusion for Adults with Stroke:

  • Hemiplegia as a result of a cerebral stroke (ischemic or hemorrhagic)
  • 0 - 3 Modified Ashworth Scale
  • >Grade 2+ bilateral shoulder flexors (ability to lift arms against gravity at least some distance)
  • The ability to follow instructions and answer questions in English (as determined by referring therapist)
  • Folstein mini - mental state test result >24 points
  • Not had orthopedic surgery in the past 6 months

This will be extended to include patients with active shoulder flexion using gravity-assist.

Exclusion Criteria:

Exclusion for adolescents with hemiplegia:

  • Predominant dystonia or muscle contracture (Modified Ashworth Scale <3)
  • Upper limb orthopedic surgery in the past six months
  • Cognitive impairment: <23 on the Mini Mental Status Exam (MMSE)
  • Receiving other therapy for upper extremity functional outcomes.

Exclusion for Adults with Stroke:

  • Predominant dystonia or muscle contracture (Modified Ashworth Scale >3)
  • Cognitive impairment: <23 on the Mini Mental Status Exam (MMSE)
  • Upper limb orthopedic surgery in the past 6 months
  • Receiving other therapy for upper extremity functional outcomes.

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): NCT02290353


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
UBC Peter Wall Institute for Advanced Studies
Investigators
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Principal Investigator: Machiel Van der Loos, PhD Associate Professor, Department of Mechanical Engineering

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Hendrik F. Machiel Van der Loos, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02290353     History of Changes
Other Study ID Numbers: H12-00220
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Hendrik F. Machiel Van der Loos, University of British Columbia:
Engagement
Motivation
Exergaming

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic