Foundation University College of Physical Therapy
Islamabad, Punjab Province, 44000, Pakistan
NCT Number: NCT07596225
Study, titled Effects of Kinect-Based Exergaming versus Wii Fit on Balance and Fall Risk among Healthy Older Adults, is a randomized controlled trial comparing the balance training effects of Xbox Kinect and Wii Fit.
After obtaining informed consent, 46 healthy older adults will be randomly allocated (1:1) using sealed envelopes to a 6-week training program in either group. Static, Dynamic, and Anticipatory balance will be assessed at baseline and post-intervention using the Biodex Balance System for objective comparison.
Looking for future studies?
Notify MeBalance is a complex, multidimensional concept related to postural control, referring essentially to the ability to maintain a stable posture. Each year, an estimated 37.3 million individuals experience a fall that requires hospitalization and may lead to severe injuries, such as fractures and traumatic brain injuries. Traditional balance exercises reduce fall risk but may have low long-term adherence in seniors. The introduction of VR-based games engages participants in interactive balance exercises.
The objective of this study is to evaluate the effects of Kinect-based exergaming compared to Wii Fit balance training on reducing fall risk in elderly individuals, focusing on parameters of Fall incidence, as well as Static, Dynamic, and Anticipatory balance.
The study will be a non-blinded Randomized Controlled Trial (RCT), consisting of 2 groups. The Study will be conducted over 1 year at the Multidisciplinary Development Lab (MDL) of the Foundation University College of Physical Therapy (FUCP).
A calculated sample of 46 subjects will be selected via a non-probability convenience sampling technique, followed by randomization in a 1:1 ratio to Group A (Kinect-based exergaming) or Group B (Wii Fit) using the sealed-envelope method.
After CBRC registration, ethical approval will be obtained from the Ethical Review Commitee (ERC) of Foundation University Medical College (FUMC).
Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Participants will then be randomly allocated to one of the 2 groups.
At baseline, investigators will assess postural control using the Postural Stability System and balance confidence using the Falls Efficacy Scale. Objective static and dynamic balance will be evaluated using the Berg Balance Scale, while cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA).
One group will be provided with Kinect-based exer-gaming balance training. The second group will be provided with the Wii Fit Balance Training. Exercise training would be performed over a 6-week intervention period, administering exercise training 3 days per week. All outcome measurements would be performed before and after the 6-week intervention period. Data will be entered and analyzed on SPSS v. 22.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 1 will receive Kinect-based exergaming balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises
Group (A) / (Kinect-based Exergaming balance training):
The total duration of the intervention protocol is 6 weeks. However, progression depends on the participant's comfort, performance, and adaptation to the training tasks. Training sessions will be done 3 days a week for 40- 50 minutes/day (18). Group 2 will receive Wii Fit balance training. Warm-up exercise will be for 5 minutes, including gentle stretching exercises, and 5 minutes will be given for a cool down, including deep breathing exercises
Group (B) / Wii Fit balance training:
Time frame: 6 weeks.
Static postural stability will be assessed using the Biodex Balance System SD at stability level 12. The Overall Stability Index (OSI) measures the variance of platform displacement during static standing. The Overall Stability Index (OSI) is expressed in degrees. Lower OSI values indicate better postural stability and reduced postural sway, whereas higher values indicate impaired balance control.
Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes
Time frame: 6 weeks
Berg Balance scale will be used. 5-point ordinal scale (graded 0-4), Max score = 56 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk R=0.88-0.98.
Time frame: 6 weeks
Fall Efficacy Scale will be used. 16 items Questionnaire. Individuals are instructed to score their concern of falling during an activity. Performed at the start of the treatment protocol, and after 8 weeks at the end of the intervention
1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total of 64. 16 = no concern about falling, > 16 = concern about falling
Time frame: 6 weeks
Montreal Cognitive Assessment (MoCA) A 30-item global cognitive screening tool scored from 0-30. Higher scores indicate better cognition.
26-30: Normal cognition 18-25: Mild cognitive impairment (MCI) 10-17: Moderate cognitive impairment
≤ 9: Severe cognitive impairment One extra point is added for individuals with ≤12 years of formal education to adjust for educational bias
Time frame: 6 weeks
Dynamic balance will be assessed using the Biodex Balance System SD at stability level 6 under unstable surface conditions. Balance performance will be quantified using the Overall Stability Index (OSI). The Overall Stability Index (OSI) is expressed in degrees.Lower OSI scores represent improved dynamic balance and neuromuscular control, whereas higher values indicate poorer balance performance.
Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes
Time frame: 6 weeks
Limits of Stability testing will be used to assess the participant's ability to intentionally displace the center of pressure toward visual targets without losing balance. Higher LOS scores indicate better anticipatory postural control and balance performance, whereas lower scores indicate impaired balance ability.
Assessment will be performed at baseline and after 6 weeks of intervention. Intervention will be conducted 3 sessions per week for 6 weeks, with each session lasting 30-45 minutes
Time frame: 6 week
The Fall Risk Test using the Biodex Balance System will assess the participant's risk of falls under progressively unstable conditions. Higher Fall Risk Index scores indicate greater fall risk and poorer balance ability, whereas lower scores indicate improved balance and reduced fall risk.
Assessment will be performed at baseline and after 6 weeks of intervention.
Foundation University Islamabad
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07328867
Balance, Brain Diseases
Islamabad, Pakistan
View Trial DetailsNCT06978517
Balance, Elderly
Islamabad, Pakistan
View Trial DetailsNCT06740227
Balance, Diabetic Peripheral Neuropathy
Islamabad, Punjab Province, Pakistan
View Trial DetailsNCT05715112
Balance, Fall Risk
Davenport, Iowa, United States
View Trial Details