Clinical trial NCT06060470: Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Official title: Mechanism of Action That Underlies an Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: Chronic stroke
Dance-based exergaming
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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:

1. The evaluate using the randomized controlled trial the efficacy of dance-based exergaming on physical function compared to conventional standard of care (fall prevention and balance training) among people with chronic stroke This pilot studies used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially available and a cost-effective device that provides similar benefits of exergaming. Community-dwelling people with chronic stroke involved in the study underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a laboratory setting. Participants were assessed for motor and cognitive performance in the laboratory during volitional and reactive balance control while performing a secondary cognitive task. The performance outcome determined the effect on physical function.

Eligibility criteria: Inclusion Criteria:

* 45 to 90 years of age.
* Able to follow instructions provided in English.
* History of neurological impairment (Stroke) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
* Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
* Cognitive skills to actively participate (score of \< 26 on Montreal cognitive assessment indicates cognitive impairment).
* Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of \> or = 2/5).

Exclusion Criteria:

* Cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment and a score of \<25 on Mini Mental State Exam Score;
* aphasia \<71% on Mississippi Aphasia Screening Test
* \>15 on Geriatric Depression Scale.
* unhealed pressure sores,
* active or untreated infection,
* thromboembolic disease,
* severe contractures,
* active heterotrophic ossification in the lower extremities,
* lower limb fractures,
* known history of peripheral nerve injury in the lower legs,
* history of cardiovascular or pulmonary complications, or with pacemakers and history of metabolic (endocrine, hepatic) or renal dysfunction, uncontrolled seizures (Self-report).
* History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (\<6months) or hospitalization (\<3months) and on any sedative drugs.
* Partcipants unavailable for 12 weeks of participation,
* Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
* Pregnancy.
* Uncontrolled pain \>3/10 on VAS.
* Complains of shortness of breath
* Uncontrolled hypertension (systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting).
* Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) \[3\].
* Oxygen saturation (measured by pulse oximeter) during resting \< 95%.
* Severe cardiac disease (New York Heart Association classification of IIIV) \[1\]. Exclusion Criteria for Laboratory Slip test.
* T score of \< -2 on the Bone density, measured through via the heel ultrasound machine.

Primary outcomes:
measure: Compliance to therapy
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Voluntary balance control
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Change in Postural Stability
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Secondary outcomes:
measure: Fall risk
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Real life falls
timeFrame: Baseline (week 0) to post-training at home (12 months)
measure: Heart rate variability
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Flow-mediated vasodilatation
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Maximal oxygen consumption
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Aerobic capacity
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Blood pressure
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Endurance
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
measure: Physical activity
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: uic
name: Savitha Subramaniam
role: PRINCIPAL_INVESTIGATOR
References: