Functional Engagement in Assisted Therapy Through Exercise Robotics

NCT02290353 | Completed

• 1 other identifier: H12-00220
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebral Palsy; Traumatic Brain Injury

Keywords

Engagement; Motivation; Exergaming

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test WMFT

  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.

  every 2 month, from date of randomization (month 0) to the end of the study (end of month 6)

Secondary Outcomes (8)

• Motricity index, grip/pinch index

  every 2 month, from date of randomization (month 0) to the end of the study (end of month 6)

• Canadian Occupational Performance Measure COPM

  every 2 month, from date of randomization (month 0) to the end of the study (end of month 6)

• Confidence scale

  one time only, at the beginning of FEAHTERS intervention

• Paediatric Motivation Scale

  every 2 weeks (during the 2 months of FEATHERS intervention)

• Usability of the System

  one time only, at the end of FEATHERS intervention

Study Arms (2)

Adult (Stroke) group

EXPERIMENTAL

This includes early intervention and late intervention sub-groups. Intervention: FEATHERS Device

Device: FEATHERS

Teenagers (Cerebral Palsy) group

EXPERIMENTAL

This includes early intervention and late intervention sub-groups. Intervention: FEATHERS Device

Device: FEATHERS

Interventions

FEATHERS DEVICE

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.

Adult (Stroke) group; Teenagers (Cerebral Palsy) group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hemiplegia as a result of a cerebral stroke (ischemic or hemorrhagic)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• UBC Peter Wall Institute for Advanced Studies: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (6)

• Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27.

  PMID: 24867924 BACKGROUND

• Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia. Dev Med Child Neurol. 2011 Apr;53(4):313-20. doi: 10.1111/j.1469-8749.2010.03859.x.

  PMID: 21401585 BACKGROUND

• Lohse K, Shirzad N, Verster A, Hodges N, Van der Loos HF. Video games and rehabilitation: using design principles to enhance engagement in physical therapy. J Neurol Phys Ther. 2013 Dec;37(4):166-75. doi: 10.1097/NPT.0000000000000017.

  PMID: 24232363 BACKGROUND

• Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.

  PMID: 24681826 BACKGROUND

• Edwards JD, Koehoorn M, Boyd LA, Levy AR. Is health-related quality of life improving after stroke? A comparison of health utilities indices among Canadians with stroke between 1996 and 2005. Stroke. 2010 May;41(5):996-1000. doi: 10.1161/STROKEAHA.109.576678. Epub 2010 Apr 1.

  PMID: 20360545 BACKGROUND

• Valdes BA, Hilderman CG, Hung CT, Shirzad N, Van der Loos HF. Usability testing of gaming and social media applications for stroke and cerebral palsy upper limb rehabilitation. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:3602-5. doi: 10.1109/EMBC.2014.6944402.

  PMID: 25570770 RESULT

Related Links

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MeSH Terms

Conditions

Stroke; Cerebral Palsy; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Machiel Van der Loos, PhD

  Associate Professor, Department of Mechanical Engineering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 14, 2014
• Study Start: April 1, 2015
• Primary Completion: November 16, 2015
• Study Completion: November 16, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

CA (1)