Clinical trial NCT05613374: Gait Training For Reducing Risk Of Fall in the Elderly
Official title: Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: The Elderly
Fall Risk
Virtual Reality
Treadmill
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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,
* ﬁxed 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

Primary outcomes:
measure: Change in the score of fall risk test . (test that assess the change in risk of fall)
timeFrame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
measure: 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)
timeFrame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
Secondary outcomes:
measure: Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)
timeFrame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Ehab Mohamed Abd El Kafy
Study officials:
affiliation: Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
name: Ehab M Abd El Kafy, PhD
role: PRINCIPAL_INVESTIGATOR
References: