Clinical trial NCT03758846: Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
Official title: Comparing Conventional and Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Healthy Aging
Keywords: Dual-task training
Cognitive-motor training
Conventional training
Virtual-reality exergaming
Dance Therapy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-11-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Neurological impairment such as stroke and aging 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 (Yoga, Tai-chi) therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke and the elderly population 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 and the elderly, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain pilot data on compliance and efficacy as well as performing power analysis and sample size calculation for developing it into a randomized controlled trial for extramural funding purposes. 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 and the elderly population.

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. A pilot study identified that supplementary cognitive training along with Wii-fit balance training resulted in improving dual-task volitional balance control post-stroke. Based on this preliminary finding, this current pilot study aimed to identify:

1. The efficacy of cognitive-motor exergaming (with Wii-fit) compared to conventional balance training among people with chronic stroke
2. Exergaming (with Kinect) on domains of balance control and cognition among people with chronic stroke
3. The efficacy of Exergaming (with Kinect) compared to conventional balance training method on domains of balance control and cognition among healthy older adults

This pilot study 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 and healthy older adults 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 cognitive-motor interference during dual-tasking.

Eligibility criteria: Inclusion/Exclusion criteria for Stroke

Inclusion Criteria:

* Participants should be 18 to 90 years of age.
* Presence of Chronic stroke (onset of stroke more than six months) confirmed by a physician
* Ability to stand independently for 5 minutes without an assistive device or any physical assistance
* Ability to understand English

Exclusion Criteria:

* A Score of less than 25 on Mini-mental state examination
* Heel bone density with T-score less than \<-2.0
* Self-reported metal implants due to any orthopedic conditions
* Presence of any other neurological impairments such as Parkinsons disease, Alzheimers disease, vestibular dysfunction, peripheral neuropathy or unstable epilepsy

Inclusion/Exclusion criteria for Older adults

Inclusion Criteria:

* Participants should be 50 to 90 years of age.
* Able to follow instructions provided in English.
* No history of neurological impairment (Stroke, Parkinson's disease and Multiple Sclerosis).
* 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).

Exclusion Criteria:

* Significant cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment indicates cognitive impairment.
* In neurologically impaired individuals, for cognitive impairment a score of \<25 on Mini Mental State Exam Score; for aphasia \<71% on Mississippi Aphasia Screening Test and \>15 on Geriatric Depression Scale.
* Heel bone density with T-score less than \<-2.0
* Participants unavailable for 6 weeks of participation.
* 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).

Primary outcomes:
measure: Change in Movement Velocity (during dual-tasking)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in Postural Stability (during single and dual-tasking)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change Cognitive Accuracy (during dual-tasking)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Compliance to therapy (total time spent over the intervention duration)
timeFrame: Baseline (Week 0) to Post-training (Week 7)
measure: Change in reaction time with functional arm reach - Dance therapy for people with stroke and healthy older adults
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary outcomes:
measure: Change in Berg Balance Scale
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in distance covered in Six minute walk test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in performance on Chair Stand Test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in performance on Four Step Square test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in Activity Specific Balance confidence
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
measure: Change in physical activity
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 7)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tanvi S Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: