Chronic Stroke Clinical Trial
Official title:
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
Verified date | October 2018 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study will look at the effect of a game-based, task-oriented home exercise program on adherence in persons with chronic (> 6 months post) stroke as compared to a standard home exercise program. The study will also look at the effect of a game-based, task-oriented home exercise program on upper extremity motor function and occupational performance in persons with chronic (> 6 months post) stroke as compared to a standard home exercise program. Finally, the study will look at barriers and facilitators to successful use of the game-based, task-oriented home exercise program in the home setting.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Stroke Subjects 1. Have a cerebrovascular accident diagnosis at least 6 months prior to study enrollment 2. Age 45-85 3. Can comprehend English 4. Have an internet connection in the home 5. Mini Mental Status Examination score > 24 (no more than mild cognitive deficits) 6. Mild to moderate motor deficits (range of motion screening- > 45 degrees shoulder flexion, some wrist movement, partial extension of the fingers) 7. Functional balance (Berg Balance Scale score > 45) - Caregivers: 1. Provide care or support to a subject that is participating in this research study. This person does not need to be related to the stroke subject. 2. Over the age of 18 3. Can comprehend English Exclusion Criteria: - Stroke Subject: 1. A medical condition that prevents interaction with a television or video games 2. Receiving occupational or physical therapy services at the time of study involvement - Caregiver: NONE |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Jurkiewicz MT, Marzolini S, Oh P. Adherence to a home-based exercise program for individuals after stroke. Top Stroke Rehabil. 2011 May-Jun;18(3):277-84. doi: 10.1310/tsr1803-277. — View Citation
Morris JH, Williams B. Optimising long-term participation in physical activities after stroke: exploring new ways of working for physiotherapists. Physiotherapy. 2009 Sep;95(3):228-34. doi: 10.1016/j.physio.2008.11.006. Epub 2009 Jan 29. — View Citation
Nicholson S, Sniehotta FF, van Wijck F, Greig CA, Johnston M, McMurdo ME, Dennis M, Mead GE. A systematic review of perceived barriers and motivators to physical activity after stroke. Int J Stroke. 2013 Jul;8(5):357-64. doi: 10.1111/j.1747-4949.2012.00880.x. Epub 2012 Sep 13. Review. — View Citation
Proffitt R, Henderson W, Scholl S, Nettleton M. Lee Silverman Voice Treatment- BIG® to improve occupational performance in stroke. American Journal of Occupational Therapy. In press.
Proffitt R, Lange B. Feasibility of a Customized, In-Home, Game-Based Stroke Exercise Program Using the Microsoft Kinect® Sensor. Int J Telerehabil. 2015 Nov 20;7(2):23-34. doi: 10.5195/ijt.2015.6177. eCollection 2015 Fall. — View Citation
Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7. — View Citation
Wolf SL, Thompson PA, Winstein CJ, Miller JP, Blanton SR, Nichols-Larsen DS, Morris DM, Uswatte G, Taub E, Light KE, Sawaki L. The EXCITE stroke trial: comparing early and delayed constraint-induced movement therapy. Stroke. 2010 Oct;41(10):2309-15. doi: 10.1161/STROKEAHA.110.588723. Epub 2010 Sep 2. — View Citation
Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. Erratum in: Circulation. 2016 Apr 12;133(15):e599. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Canadian Occupational Performance Measure | The Canadian occupational Performance Measure is a measure of the subject's self-rated performance and satisfaction of their performance with 5 self-identified areas of occupation/activities. | Baseline, 8 weeks | |
Secondary | Change from baseline in the Performance Assessment of Self-Care Skills | The Performance Assessment of Self-Care Skills (PASS) assesses basic self-care and instrumental activities of daily living. Subscales: Independence, Safety, Adequacy (minimum: 0, maximum: 3). There is no total score reported. | Baseline, 8 weeks | |
Secondary | Change from baseline in the Modified Ashworth Scale | Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint). | Baseline, 8 weeks | |
Secondary | Change from baseline in the range of motion of shoulder | Angle (degrees) of the shoulder joint as measured by a goniometer | Baseline, 8 weeks | |
Secondary | Change from baseline in the bicep strength | Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5) | Baseline, 8 weeks | |
Secondary | Change from baseline in the PROMIS-29 | General assessment of quality of life and participation in daily life. Assessment is from the standardized NIH Toolbox. T-scores are reported on scale of 0-100 (50 is average). | Baseline, 8 weeks | |
Secondary | Mini-Mental Status Examination | Questionnaire used to measure cognitive impairment | Screening | |
Secondary | Demographic and Health History Questionnaire | Includes questions related to demographics and health history | Baseline assessment | |
Secondary | Intrinsic Motivation Inventory | Determines the person's motivation for completing the task. Non-standardized scale. Scores are calculated for the following sub-scales: Interest/enjoyment, perceived competence, perceived choice, pressure/tension. There are no normative values | 8 weeks | |
Secondary | Range of Motion Screening | Participant will be screened to see if they have the minimal movement at the shoulder and elbow. | Screening | |
Secondary | Berg Balance Scale | Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45 | Screening | |
Secondary | Change from baseline in the Fugl-Meyer Assessment - Upper Extremity | Assessment of upper extremity function post-stroke. Scale ranges from 0-66. | Baseline, 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03780296 -
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
|
N/A | |
Not yet recruiting |
NCT06057584 -
Effect of Somatosensory Motor Intergration Training on Post-stroke Upper Limb Function.
|
N/A | |
Completed |
NCT03228264 -
A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.
|
N/A | |
Completed |
NCT02364232 -
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
|
N/A | |
Completed |
NCT04121754 -
Post-Stroke Walking Speed and Community Ambulation Conversion Study
|
N/A | |
Completed |
NCT04574687 -
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
|
N/A | |
Recruiting |
NCT04974840 -
Thera-band Resisted Treadmill Training for Chronic Stroke Patients
|
N/A | |
Recruiting |
NCT04534556 -
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
|
N/A | |
Completed |
NCT04553198 -
Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
|
N/A | |
Completed |
NCT04226417 -
Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
|
N/A | |
Recruiting |
NCT06049849 -
Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators
|
N/A | |
Active, not recruiting |
NCT02881736 -
Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients
|
N/A | |
Completed |
NCT03208634 -
Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke
|
N/A | |
Completed |
NCT05183100 -
Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke
|
N/A | |
Completed |
NCT03326349 -
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
|
N/A | |
Recruiting |
NCT04721860 -
Optimizing Training in Severe Post-Stroke Walking Impairment
|
N/A | |
Recruiting |
NCT06051539 -
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
|
N/A | |
Not yet recruiting |
NCT06060470 -
Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
|
N/A | |
Recruiting |
NCT05591196 -
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
|
N/A | |
Recruiting |
NCT06116942 -
Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
|
N/A |