Gait Training For Reducing Risk Of Fall in the Elderly

NCT ID: NCT05613374

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-01-15

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.

Conditions

Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Participants in the control group will receive conventional functional training (conventional physical therapy program) for one hour as the following.

• Part (1) Postural reactions exercises. (for 30 minutes)
• Rest for 15 minutes between the first part and the second part.
• Part (2) Indoor open environment gait training exercises (over-ground gait training exercises.). (for 30 minutes)

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy Program

Intervention Type: OTHER

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)

Experimental Group

Participants in the experimental group will receive a treatment program that is comprised of two parts.

The first part included training, for (30 minutes), on The C-Mill virtual reality treadmill. The C-Mill is an instrumented treadmill with interactive virtual reality games and applications. The C-Mill applies an augmented virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and performance in everyday life.

There will be 15 minutes rest between parts one and two of the training program

The second part (conventional training program) (30 minutes) will include:

• Postural reactions exercises. ( 20 minutes)
• Indoor open environment gait training exercises (over-ground gait training exercises.). (10 minutes)

Group Type: EXPERIMENTAL

The C-Mill virtual reality treadmill

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab M Abd El Kafy, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University

Locations

Ehab Mohamed Abd El Kafy

Mecca, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

22UQU4280521DSR01

Identifier Type: -

Identifier Source: org_study_id