Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-04-27
Brief Title:
Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly
Sponsor:
Imam Abdulrahman Bin Faisal University
Organization:
Imam Abdulrahman Bin Faisal University
Study Overview
Official Title:
Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly Population A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Aging is characterized by reduced cognitive and physical functions consequently balance falling and different activities of daily living get exaggerated reductions Psychological status and falling are related bidirectionally Depression is a common mental or mood disorder affecting more than 264 million people worldwide It is a recurrent state of unhappiness and loss of interest It is not simple as fluctuating mood because of short emotional response To prevent falling functional mobility and impairment of balance should be addressed Many studies have shown that treadmill training is effective in improving the elderly persons ability to walk The C-Mill treadmill afford a safe virtual reality environment and challenging obstacles and balance games which increase of walking and improve everyday life performance Aims This study aims are to investigate the clinical effectiveness of virtual reality treadmill training on psychological status and balance in elderly population in addition to compare the significant differences between them Materials Methods Fifty-Eight elderly participants will be equally and randomly assigned to Group-I Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session 2 session week for six successive weeks Group-II Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session 2 session week for six successive weeks Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2 Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test whereas the functional capacity will be measured by using 6 MWT Statistical analysis The data will be statistically analysis by using SPSS version 25 The Shapiro walk test will be used to examine the normality of data distribution Independent t- test will be used to determine significant differences between two groups between groups and paired t- test to determine significant differences before and after intervention in both groups Significance level at 005 and confidence interval CI with 95
Detailed Description:
Fifty-Eight elderly participants will be equally and randomly assigned to Group-I Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session 2 session week for six successive weeks Group-II Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session 2 session week for six successive weeks Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2 Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test whereas the functional capacity will be measured by using 6 MWT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None