Clinical trial NCT05623462: Virtual Reality Training for Walking Improvement in the Elderly
Official title: Virtual Reality Treadmill Training for Improving Gait Performance in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Unsteady
Keywords: Gait
Older Adults
Virtual Reality
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes. The practice of complex and challenging situations of the usual daily walking is very important to prevent balance loss and falls in the elderly.

Researchers reported that subjects trained in a virtual environment with enhanced feedback performed walking skills better than those trained with conventional methods. The C-Mill treadmill is an innovative device that was recently used for the training of impaired gait and balance. C-Mill treadmill uses virtual reality, augmented feedback, and force plate technology that provides the best solution for efficient functional movement therapy. Therefore, this study will evaluate the efficacy of gait training with a virtual reality treadmill on walking abilities in elderly people.

Detailed description: Many studies have shown that walking exercises effectively contribute to enhancing walking performance in the elderly. Several studies have shown that treadmill training is effective in improving the elderly person's ability to walk. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to improve walking. Unfortunately, older adults have few opportunities to practice safe walking well and consistently in a task-specific manner.

There are many studies that have shown that gait training in a challenging environment, such as walking on a treadmill, is more effective in improving the elderly person's ability to walk properly, compared to the traditional training exercise regimen that relies on training in closed training environment free from challenges and obstacles.

Virtual reality technology is one of the advanced technologies used in physical therapy and rehabilitation. This technology contributes to creating an interactive environment for the trainees that enables them to integrate into the training process and encourages them to perform controlled motor tasks. C-Mill treadmill applies a virtual reality environment, dual-tasking exercises, obstacle avoidance games, and a variety of gait challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life. Many studies found that the C-Mill treadmill is effective in improving gait performance and adaptability in clinical practice Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy program on walking abilities in elderly people.

Eligibility criteria: Inclusion Criteria:

40 healthy older adults, both sexes, will participate in this study. Their ages will be between 65 to 75 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 gait parameter (stride length) (This parameter indicated the change of gait performance).
timeFrame: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
measure: Change in the gait parameter (stride time) (This parameter indicated the change of gait performance).
timeFrame: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
measure: Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
timeFrame: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
measure: Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
timeFrame: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
measure: The change in the six-minute walk test score ((This parameter indicated the change of walking tolerance abilities).
timeFrame: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Secondary outcomes:
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, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
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: