Gait Training For Reducing Risk Of Fall in the Elderly

Fall Clinical Trial

Official title:

Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05613374
• Other study ID #: 22UQU4280521DSR01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: November 2022
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falling is considered one of the major problems that may affect the elderly, which may lead to bad consequences. Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes.Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is an innovative device that recently used for the training of impaired gait and balance.Therefore, this study will aim to evaluate the efficacy of gait training with a virtual reality treadmill on the risk of fall in the elderly.

Description:

Fall injuries produce serious threats to elderly people. Fall hazards are many, they include physical, psychological, social, and economic consequences. Many studies have shown that walking and balance exercises effectively contribute to enhancing walking performance, improving obstacle avoidance, and reducing the incidence of falls in the elderly. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to prevent falls. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is recently used for the training of impaired gait and balance. C-Mill applies a virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life.Fall injuries produce serious consequences. The management of these injuries is costly and has a negative impact on healthcare entities. Therefore, prevention programs for preventing and reducing falls among the elderly are very important for reducing these serious consequences. Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy training program on the risk of fall in the elderly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

Inclusion Criteria:

60 healthy older adults, both sexes, will participate in this study. Their ages will be between 60 to 70 years. They should have stable medical status based on a confirmed written medical report signed by their physicians. All participants should not receive other training to improve their balance and gait during the duration of the study application except through this study training program.

Exclusion Criteria:

The exclusion criteria will include any participant with:

• a cognitive reduction (< 23 points based on the Mini-Mental State Examination scale;

• muscle paralysis,

• ?xed lower limb bony deformities,

• balance deficits,

• visual problems,

• diabetes mellitus,

• polyneuropathy,

• gait disorders,

• using assistive walking devices during walking,

• vertigo, anti-seizures drug use and hypertension,

• vestibular and cerebellar problems; and

• auditory and perceptual diseases/impairments

Related Conditions & MeSH terms

• Fall

Intervention

Device:
• The C-Mill virtual reality treadmill
The C-Mill treadmill is an innovative device used for the training of impaired gait and balance. The C-Mill is an instrumented treadmill with interactive virtual reality games and applications.The instrument is supplied with a safety frame, body weight support, treadmill force plates, treadmill belt, adjustable handrails, cameras, user operating system, interactive visual screen and augmented reality projection.

Other:
• Conventional Physical Therapy Program
The Conventional Physical Therapy Program include the following: Postural reactions exercises. (using balance board, balance beam, and manual balance perturbations) Indoor open environment gait training exercises (over ground gait training exercises.). (using obstacles,cones , stepper, balance board , and uneven surfaces) (either between or outside the parallel bar)

Locations

Country	Name	City	State
Saudi Arabia	Ehab Mohamed Abd El Kafy	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the score of fall risk test . (test that assess the change in risk of fall)	The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level (11) will be selected for applying the fall risk test. The result for every child will be registered and compared to the normative data stored in the software of the device based on children age range.	[Data will be collected at baseline, and 6 weeks after intervention commencement]
Primary	Change in the Overall Stability Index {percentage value (%)}, and Time of Control {seconds} for Limit of Stability Test (test that assess the change in balance ability)	The Biodex Balance System will be used to assess the change in the Overall Stability Index and the Time of Control of the Limit of Stability Test. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control. The test also include measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.	[Data will be collected at baseline, and 6 weeks after intervention commencement]
Secondary	Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)	The Timed Up and Go Test (TUG) will be used to assess the following parameters in older adults: fall risk, walking ability, balance, and mobility. It is a reliable, valid and sensitive test that is a specific measure of the probability for falls among elderly.	[Data will be collected at baseline, and 6 weeks after intervention commencement]