Gait Training For Reducing Risk Of Fall in the Elderly

NCT05613374 | Completed

• 1 other identifier: 22UQU4280521DSR01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Keywords

The Elderly; Fall Risk; Virtual Reality; Treadmill

Outcome Measures

Primary Outcomes (2)

• 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]

• 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 Outcomes (1)

• Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)

  [Data will be collected at baseline, and 6 weeks after intervention commencement]

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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)

Other: Conventional Physical Therapy Program

Experimental Group

EXPERIMENTAL

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)

Device: The C-Mill virtual reality treadmill

Interventions

The C-Mill virtual reality treadmill 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.

Experimental Group

Conventional Physical Therapy Program 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)

Control Group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Ehab Mohamed Abd El Kafy

Mecca, 21955, Saudi Arabia

Location

Study Officials

• Ehab M Abd El Kafy, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: November 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: February 3, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa

Locations

SA (1)