FallNCT05613374
Gait Training For Reducing Risk Of Fall in the Elderly
A study testing The C-Mill virtual reality treadmill and Conventional Physical Therapy Program in people with Fall, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- The C-Mill virtual reality treadmill and Conventional Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.
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.
Read the 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
- Being tested
- The C-Mill virtual reality treadmill, Conventional Physical Therapy Program
- Keywords
- The Elderly, Fall Risk, Virtual Reality, Treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The C-Mill virtual reality treadmillDevice
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.
Conventional Physical Therapy ProgramOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: The C-Mill virtual reality treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [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)
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.
Measured: [Data will be collected at baseline, and 6 weeks after intervention commencement]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Nov 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
- Investigators
- Ehab M Abd El Kafy, PhD, Principal investigator, Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613374
- Sponsor's protocol ID
- 22UQU4280521DSR01
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- The data available is Case-by-case basis at the discretion of Primary Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.
- ClinicalTrials.gov ID
- NCT05613374
- Acronym / sponsor ID
- 22UQU4280521DSR01
- Conditions
- Fall
- Keywords
- The Elderly, Fall Risk, Virtual Reality, Treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Physical Therapy ProgramParticipants 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) |
| Experimental Group | Experimental | Device: The C-Mill virtual reality treadmillParticipants 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) |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- a cognitive reduction (< 23 points based on the Mini-Mental State Examination scale;
- muscle paralysis,
- fixed lower limb bony deformities,
- balance deficits,
- visual problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The C-Mill virtual reality treadmillThe 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. | Device | Experimental Group |
| Conventional Physical Therapy ProgramThe 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) | Other | Control Group |
Primary outcome
Change in the score of fall risk test . (test that assess the change in risk of fall)
Time frame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
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.
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)
Time frame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
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.
1 secondary outcome
Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)
Time frame: [Data will be collected at baseline, and 6 weeks after intervention commencement]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Yes. - The data available is Case-by-case basis at the discretion of Primary Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab M Abd El Kafy, PhD principal investigator
Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The C-Mill virtual reality treadmill and Conventional Physical Therapy Program in people with Fall, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of fall risk test . (test that assess the change in risk of fall) (time frame: [Data will be collected at baseline, and 6 weeks after intervention commencement]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.