Stroke Clinical Trial
— FEATHERSOfficial title:
Functional Engagement in Assisted Therapy Through Exercise Robotics
Verified date | March 2017 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 16, 2015 |
Est. primary completion date | November 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | UBC Peter Wall Institute for Advanced Studies |
Canada,
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. — View Citation
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. Review. — View Citation
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 Mar 28. — View Citation
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. — View Citation
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. — View Citation
Valdés 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. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:3602-5. doi: 10.1109/EMBC.2014.6944 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Motricity index, grip/pinch index | 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 | Canadian Occupational Performance Measure COPM | 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 | Confidence scale | 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. |
one time only, at the beginning of FEAHTERS intervention | |
Secondary | Paediatric Motivation Scale | 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. |
every 2 weeks (during the 2 months of FEATHERS intervention) | |
Secondary | Usability of the System | 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. |
one time only, at the end of FEATHERS intervention | |
Secondary | Modified Rankin Test | administer at enrollment in the study | one time only, at the beginning of the study | |
Secondary | Reach Performance Scale | 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 | Game-based kinematic test | 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. |
every 2 weeks (during the 2 months of FEATHERS intervention) |
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