University of Illinois at Chicago
Chicago, Illinois, 60612, United States
NCT Number: NCT06060470
Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.
Trial opening soon.
Get Notified45 year–90 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
While conventional balance training facilitates balance control and gait functions, the exercises involved in the training are labor-intensive, highly repetitious leading to monotonicity and decreased motivation levels. Therefore, many health care researchers are involved in identifying various methods to reduce the risk of falls addressing the barriers in conventional training methods while having the potential to translate it at home. Pilot studies with dance-based exergaming resulted in improving balance control and cognition post-stroke. Based on this preliminary finding, this current study aimed to identify:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.
Other names: Active Balance Cardio (ABC) care
Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.
Other names: Control
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Total time spent over the intervention duration. In virtual reality-based group a score of thirty two (number of sessions) is the maximum and a score of zero is minimum. While in the Active comparator group: control, ten is the maximum score and zero is the minimum. Higher score indicates increase compliance to therapy.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Examining maximum center of pressure (CoP) excursion on the Limits of Stability task test using Phyiosensing. Directional control, endpoint excursion, maximum excursion results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher scores better direction, endpoint, and excursion, while lower indicates viceversa.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Postural Stability can be defined by simultaneous control of center of mass position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
falls efficacy scale questionnaire. Falls Efficacy Scale (FES), an instrument to measure fear of falling, based on the operational definition of this fear as "low perceived self-efficacy at avoiding falls during essential, nonhazardous activities of daily living. A total score of greater than 70 indicates that the person has a fear of falling. Lower scores indicate person has lesser fear of falling.
Time frame: Baseline (week 0) to post-training at home (12 months)
Real life falls will be assessed with fall log diary. Higher number indicates increased falls history. Partcipants will be monitored for one year.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Heart rate variability will be assessed by recording HRV, fluctuations of heart rate at specific time intervals using a heart rate monitor test protocol of the Polar® heart rate monitor. Higher scores indicate better autonomic modulation (cardiac function).
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Will be evaluated by recording brachial artery flow-mediated vasodilation - FMD; an index of arterial endothelial function with ultrasound imaging (Doppler ultrasound test) of the brachial artery. Flow-mediated vasodilatation results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher percentage indicate higher vascular health.
[Time Frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)].
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Will be assessed using the YMCA submaximal cycle ergometer test explained in the Y's Way to Physical Fitness. Higher scores indicate better aerobic capacity.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
2-minute step test - The 2 Minute Step Test is used to assess an individual's aerobic capacity and evaluate their level of functional fitness. Seps range from 44-116 in health older adults. Higher scores indicate better aerobic endurance.
[Time Frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)].
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
2 mins pre-and post-training. Both systolic and diastolic will be measured.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
6-minute walk test - The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes.
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Fitbit-monitored daily steps. Higher number of steps indicate better physical activity..
Contact information is provided by the study sponsor or research team.
Savitha Subramaniam
CONTACT
savitha subramaniam
CONTACT
University of Illinois at Chicago
Other
Mechanism of Action That Underlies an Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Acronym: ABCcare
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