AgingNCT04336670
Design and Implementation of a Physical Exercise Program With Virtual Reality to Improve Functional Capacities in Older People.
A study testing Immersive Virtual Reality exercise program in people with Aging and Fall, run by Pablo Campo-Prieto at 1 site in Spain.
Trial summary
TITLE: Desing and implementation of a Immersive Virtual Reality exercise program to improve balance in older people INTRO: Older people grow around the world at a faster rate than any other age group, resulting in an accelerated aging of the population and an increase in life expectancy. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Fall, Quality of Life
- What is being tested?
- Immersive Virtual Reality exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 11 Oct 2021to 29 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Saraiva Senior Center members
- Signed informed consent
Who cannot join
- Comorbidity that discourages the exercise of physical exercise and that allows to carry out all the programmed evaluations.
- Mobility problems that prevent compliance with the protocol.
- Serious visual and / or auditory disturbances that impede the development of the session, as well as those with a history of vertigo, seizures or epileptic seizures to prevent exacerbations of these symptoms as potential adverse effects of Immersive Virtual Reality.
- Severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Implementation of a Immersive Virtual Reality Physical Exercise Program to Improve Functional Capacities in Older People.
TITLE: Desing and implementation of a Immersive Virtual Reality exercise program to improve balance in older people
INTRO: Older people grow around the world at a faster rate than any other age group, resulting in an accelerated aging of the population and an increase in life expectancy. In response to this new reality, active aging programs and strategies are especially relevant and it based in physical activity practice, whose main objective is to maintain or improve the functionality of the person, even though the loss of balance in the elderly represents a significant difficulty in their lives, since this aspect reduces their postural control, increasing the risk of falls and injuries. Our project REVIEM (Inmersive Virtual Reality Exergaming in Olders) is a new strategy to improve the balance in older people, using a exercise program with Virtual Reality glasses for this purpose.
Read more
HYPOTHESIS: The practice of REVIEM protocol based on physical function training in older adults collaborates in the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy.
GENERAL GOALS:
1.1 Design and implement a REVIEM exercise program / protocol to improve balance in older people 1.2 Analyze the effects of this REVIEM program / protocol, in the short and medium term in institutionalized individuals.
1.3 Identify if there is a relationship between the variables that induce fragility and functional dependence and the REVIEM protocol
SPECIFIC GOALS:
2.1 Determine the REVIEM protocol to improve differential effects for 6 minutes a day (3 days a week for 10 weeks)
2.1.1 The improvement of the functional independence of individuals by improving balance, reducing the risk of falls and proper development in activities of daily living.
2.1.2 The improvement of gait. 2.1.3 The improvement of quality of life. 2.1.4 The improvement of handgrip.
2.2 Determine the parameters related to immerse virtual reality exposure. 2.2.1 Safety of the virtual reality exposure 2.2.2 Usability of the virtual reality exposure 2.2.3 Personal experiences and satisfaction of the virtual reality exposure
METHODS:
Design: Randomized controlled trial. The institutionalized elderly from the geriatric center Saraiva Senior Center in Pontevedra, Spain, will be invited to take part in the study. After they meet the selection criteria, they will be assigned to on experimental group and one control group. Information regarding sociodemographic characteristics and a clinical anamnesis of the participants will be collected.
Intervention: Two groups (experimental and control). Experimental group will perform the REVIEM protocol sessions (6 min) focused on the upper and lower limbs. (3 sessions per week for 10 weeks). All sessions will begin with a warm-up focused on the stimulation of coordination and joint mobilization, so that the body is predisposed both centrally and peripherally for the performance of the session and will end with a stretching routine accompanied by breathing cycles calm and controlled. The session will be supervised by the physiotherapist, occupational therapist or expert in physical exercise of the center.
Control group will participate in the usual activities proposed by the center management.
Assessments: 4 evaluations will be carried: initial, intermediate (at 1 month), final (at 10 weeks) and follow-up (1 month after to end the program).
The contents of the assessmentens will be:
- Characteristics of patients: "ad hoc" record sheet that will include data on age, sex, associated pathologies and pharmacological treatment.
- REVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
- Balance, gait and fall risk (Tinetti Test) 3. Functional mobility and lower limbs strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test) 5. Quality of life (SF-12 Scale) 6. Handgrip (dynamometer)
Hypothesis : our findings aim to support the use of new health technologies in the field of rehabilitation and healthcare for the elderly, achieving a feasible and safety Immersive Virtual Reality exergaming program.
- Conditions
- Aging, Fall, Quality of Life
- Being tested
- Immersive Virtual Reality exercise program, Usual care
- Keywords
- Aged, Virtual Reality Exposure Therapy, Balance, Biomedical Technology, Exercise Therapy, Physical Therapy Modalities, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality exercise programDevice
Sessions with an exercise program focused in upper and low limbs movements in a virtual enviroment, all performed in standing position.
Usual careOther
Usual center therapies (Physical therapy, occupational therapy..)
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Immersive Virtual Reality exercise program + Usual center therapies Receives: Device: Immersive Virtual Reality exercise program |
| Usual activities group | Active comparator | Usual center therapies Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness Questionnaire
SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.
Measured: 4 weeks
Simulator Sickness Questionnaire
SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.
Measured: 10 weeks
System Usability Scale
SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
Measured: 4 weeks
System Usability Scale
SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
Measured: 10 weeks
Game Experience Questionnaire (post game module)
GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).
Measured: 4 weeks
Game Experience Questionnaire (post game module)
GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).
Measured: 10 weeks
Tinetti Test
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Measured: pre intervention
Tinetti Test
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Measured: 10 weeks
Tinetti Test
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Measured: 14 weeks
Five times sit to stand test
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Measured: pre intervention
Five times sit to stand test
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Measured: 10 weeks
Five times sit to stand test
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Measured: 14 weeks
Time Up and Go Test
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Measured: pre intervention
Time Up and Go Test
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Measured: 10 weeks
Time Up and Go Test
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Measured: 12 weeks
SF-12 Scale
It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).
Measured: pre intervention
SF-12 Scale
It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).
Measured: 10 weeks
Strengh
handgrip strength
Measured: pre intervention
Strengh
handgrip strength
Measured: 10 weeks
Strengh
handgrip strength
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start11 Oct 2021
- Primary completion11 Oct 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pablo Campo-Prieto
- Sponsor type
- University, hospital or other
- Collaborators
- Saraiva Senior Center
- Responsible party
- Sponsor-investigator, Pablo Campo-Prieto, University of Vigo
- Investigators
- Pablo Campo-Prieto, PT M. Sc., Principal investigator, HealthyFit Research Group - University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336670
- Sponsor's protocol ID
- HEALTHYFIT-UVIGO 2020/078
- Status last verified
- Nov 2022
- First submitted
- 31 Mar 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Implementation of a Immersive Virtual Reality Physical Exercise Program to Improve Functional Capacities in Older People.
- ClinicalTrials.gov ID
- NCT04336670
- Acronym / sponsor ID
- HEALTHYFIT-UVIGO 2020/078
- Conditions
- Aging, Fall, Quality of Life
- Keywords
- Aged, Virtual Reality Exposure Therapy, Balance, Biomedical Technology, Exercise Therapy, Physical Therapy Modalities, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pablo Campo-PrietoUniversity, hospital or other
- Collaborators
- Saraiva Senior Center
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 7 Apr 2020 (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.
TITLE: Desing and implementation of a Immersive Virtual Reality exercise program to improve balance in older people
INTRO: Older people grow around the world at a faster rate than any other age group, resulting in an accelerated aging of the population and an increase in life expectancy. In response to this new reality, active aging programs and strategies are especially relevant and it based in physical activity practice, whose main objective is to maintain or improve the functionality of the person, even though the loss of balance in the elderly represents a significant difficulty in their lives, since this aspect reduces their postural control, increasing the risk of falls and injuries. Our project REVIEM (Inmersive Virtual Reality Exergaming in Olders) is a new strategy to improve the balance in older people, using a exercise program with Virtual Reality glasses for this purpose.
HYPOTHESIS: The practice of REVIEM protocol based on physical function training in older adults collaborates in the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy.
GENERAL GOALS:
1.1 Design and implement a REVIEM exercise program / protocol to improve balance in older people 1.2 Analyze the effects of this REVIEM program / protocol, in the short and medium term in institutionalized individuals.
1.3 Identify if there is a relationship between the variables that induce fragility and functional dependence and the REVIEM protocol
SPECIFIC GOALS:
2.1 Determine the REVIEM protocol to improve differential effects for 6 minutes a day (3 days a week for 10 weeks)
2.1.1 The improvement of the functional independence of individuals by improving balance, reducing the risk of falls and proper development in activities of daily living.
2.1.2 The improvement of gait. 2.1.3 The improvement of quality of life. 2.1.4 The improvement of handgrip.
2.2 Determine the parameters related to immerse virtual reality exposure. 2.2.1 Safety of the virtual reality exposure 2.2.2 Usability of the virtual reality exposure 2.2.3 Personal experiences and satisfaction of the virtual reality exposure
METHODS:
Design: Randomized controlled trial. The institutionalized elderly from the geriatric center Saraiva Senior Center in Pontevedra, Spain, will be invited to take part in the study. After they meet the selection criteria, they will be assigned to on experimental group and one control group. Information regarding sociodemographic characteristics and a clinical anamnesis of the participants will be collected.
Intervention: Two groups (experimental and control). Experimental group will perform the REVIEM protocol sessions (6 min) focused on the upper and lower limbs. (3 sessions per week for 10 weeks). All sessions will begin with a warm-up focused on the stimulation of coordination and joint mobilization, so that the body is predisposed both centrally and peripherally for the performance of the session and will end with a stretching routine accompanied by breathing cycles calm and controlled. The session will be supervised by the physiotherapist, occupational therapist or expert in physical exercise of the center.
Control group will participate in the usual activities proposed by the center management.
Assessments: 4 evaluations will be carried: initial, intermediate (at 1 month), final (at 10 weeks) and follow-up (1 month after to end the program).
The contents of the assessmentens will be:
- Characteristics of patients: "ad hoc" record sheet that will include data on age, sex, associated pathologies and pharmacological treatment.
- REVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
- Balance, gait and fall risk (Tinetti Test) 3. Functional mobility and lower limbs strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test) 5. Quality of life (SF-12 Scale) 6. Handgrip (dynamometer)
Hypothesis : our findings aim to support the use of new health technologies in the field of rehabilitation and healthcare for the elderly, achieving a feasible and safety Immersive Virtual Reality exergaming program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Device: Immersive Virtual Reality exercise programImmersive Virtual Reality exercise program + Usual center therapies |
| Usual activities group | Active comparator | Other: Usual careUsual center therapies |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Saraiva Senior Center members
- Signed informed consent
Key exclusion criteria (4 listed)
- Comorbidity that discourages the exercise of physical exercise and that allows to carry out all the programmed evaluations.
- Mobility problems that prevent compliance with the protocol.
- Serious visual and / or auditory disturbances that impede the development of the session, as well as those with a history of vertigo, seizures or epileptic seizures to prevent exacerbations of these symptoms as potential adverse effects of Immersive Virtual Reality.
- Severe cognitive impairment.
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 |
|---|---|---|
| Immersive Virtual Reality exercise programSessions with an exercise program focused in upper and low limbs movements in a virtual enviroment, all performed in standing position. | Device | Virtual Reality group |
| Usual careUsual center therapies (Physical therapy, occupational therapy..) | Other | Usual activities group |
Primary outcome
Simulator Sickness Questionnaire
Time frame: 4 weeks
SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.
Simulator Sickness Questionnaire
Time frame: 10 weeks
SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.
System Usability Scale
Time frame: 4 weeks
SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
System Usability Scale
Time frame: 10 weeks
SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
Game Experience Questionnaire (post game module)
Time frame: 4 weeks
GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).
Game Experience Questionnaire (post game module)
Time frame: 10 weeks
GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).
Tinetti Test
Time frame: pre intervention
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Tinetti Test
Time frame: 10 weeks
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Tinetti Test
Time frame: 14 weeks
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.
Five times sit to stand test
Time frame: pre intervention
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Five times sit to stand test
Time frame: 10 weeks
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Five times sit to stand test
Time frame: 14 weeks
FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements
Time Up and Go Test
Time frame: pre intervention
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Time Up and Go Test
Time frame: 10 weeks
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Time Up and Go Test
Time frame: 12 weeks
Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
SF-12 Scale
Time frame: pre intervention
It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).
SF-12 Scale
Time frame: 10 weeks
It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).
Strengh
Time frame: pre intervention
handgrip strength
Strengh
Time frame: 10 weeks
handgrip strength
Strengh
Time frame: 14 weeks
handgrip strength
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 10 Nov 2022.
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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.
Pablo Campo-Prieto, PT M. Sc. principal investigator
HealthyFit Research Group - University of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality exercise program in people with Aging and Fall, run by Pablo Campo-Prieto at 1 site in Spain.
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 2 inclusion and 4 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 10 Nov 2022. 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 Spain. 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?
Simulator Sickness Questionnaire (time frame: 4 weeks). The study lists 20 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 10 Nov 2022.