Virtual RealityNCT03872193
Effects of Virtual Reality on Transtibial Amputation Physiotherapy Outcomes
A study testing Exercise in people with Virtual Reality, run by Hacettepe University.
Trial summary
The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2016to 10 Jun 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- transtibial and unilateral amputation
- At least 1 year prothesis usage, 18- 65 year age,
- At least 15 min independent walking ability,
- Stabile stump volume,
- Standart stump lentgh,
- Enough kognition for evaluation and tests.
Who cannot join
- walking and other activities to prevent; shortness of muscle, limitation of joint motion and phantom pain in stump, presence of any discomfort or systemic health problem that may affect the gait outside the amputation
- presence of visual problems to prevent participation in virtual reality applications,
- use of walking aids
About this study
Official title: Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.
Read the detailed description
The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation.20 transtibial amputee with 36 mean age were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed, standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.
For this purpose, SF-36 Questionnaire, 6-minute walking test, one leg rest time, Trinity Amputation and Prosthetic Experience Scale, wearable biometric device and footprint method were utilized. There was a statistically significant difference between the two groups in pre-treatment and post-treatment performance, balance and gait parameters in the groups of individuals (p <0.05). The quality of life pain parameter was statistically decline in the group receiving virtual reality (p<0.05). On the other hand, significant differences in the quality of life and prosthesis adaptation of the individuals were not found between the groups (p> 0.05). The results of this study showed that virtual reality practices and standard physiotherapy methods are effective on performance, balance and walking in transtibial amputee rehabilitation. It is thought that it will be important to perform virtual reality applications in amputee rehabilitation separately in both methods, in addition to standard physiotherapy methods, to include in rehabilitation process, to bring an ability of alternative application to professionals working in this area and to work about amputees with using different suspension systems and with different amputation levels.
- Conditions
- Virtual Reality
- Being tested
- Exercise
- Keywords
- Amputation, Virtual Reality, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Virtual Reality Exercies
| Study group | Role | What they receive |
|---|---|---|
| Physio Therapy | Experimental | We intervention this group some routine exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. Receives: Other: Exercise |
| Virtual Reality | Experimental | This group had physical therapy program plus virtual reality exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. And virtual reality exercises were done for this group. Skiing,kayak, football,rafting and jumping activities were done in this exerciese. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life measured of individuals: SF-36 Scale
SF-36 Quality of Life Scale, higher values represent a better
Measured: 10 minute
Balance Test
Single Leg Balance Test,higher values represent a better
Measured: 5 minute
Performance Test
6 minute walk test,higher values represent a better
Measured: 6 minute
Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale
Trinity Amputation Prothesis Experience Scale; 5 point likert scale,5-75 point, activity limitation,physicosocial adaptation,prothesis satisfaction
Measured: 5 minute
Gait Parameters
Wearable Biometric Device
Measured: 6 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start10 Jul 2016
- Primary completion12 Mar 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Model description
- One group only physiotherapy second group takes physiotherapy and virtual reality exercises.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Erbahceci, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872193
- Sponsor's protocol ID
- Virtual Reality Physiotherapy
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim Sahan T, Erbahceci F. Effects of Virtual Reality on Transtibial Amputation Rehabilitation Outcomes: A Randomized Study. Games Health J. 2023 Dec;12(6):459-467. doi: 10.1089/g4h.2023.0052. Epub 2023 Nov 7.
PubMed 37934289B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
- ClinicalTrials.gov ID
- NCT03872193
- Acronym / sponsor ID
- Virtual Reality Physiotherapy
- Conditions
- Virtual Reality
- Keywords
- Amputation, Virtual Reality, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Jul 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 13 Mar 2019 (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.
The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.
Detailed description
The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation.20 transtibial amputee with 36 mean age were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed, standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.
For this purpose, SF-36 Questionnaire, 6-minute walking test, one leg rest time, Trinity Amputation and Prosthetic Experience Scale, wearable biometric device and footprint method were utilized. There was a statistically significant difference between the two groups in pre-treatment and post-treatment performance, balance and gait parameters in the groups of individuals (p <0.05). The quality of life pain parameter was statistically decline in the group receiving virtual reality (p<0.05). On the other hand, significant differences in the quality of life and prosthesis adaptation of the individuals were not found between the groups (p> 0.05). The results of this study showed that virtual reality practices and standard physiotherapy methods are effective on performance, balance and walking in transtibial amputee rehabilitation. It is thought that it will be important to perform virtual reality applications in amputee rehabilitation separately in both methods, in addition to standard physiotherapy methods, to include in rehabilitation process, to bring an ability of alternative application to professionals working in this area and to work about amputees with using different suspension systems and with different amputation levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group only physiotherapy second group takes physiotherapy and virtual reality exercises.
| Arm | Type | Receives |
|---|---|---|
| Physio Therapy | Experimental | Other: ExerciseWe intervention this group some routine exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. |
| Virtual Reality | Experimental | Other: ExerciseThis group had physical therapy program plus virtual reality exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. And virtual reality exercises were done for this group. Skiing,kayak, football,rafting and jumping activities were done in this exerciese. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- transtibial and unilateral amputation
- At least 1 year prothesis usage, 18- 65 year age,
- At least 15 min independent walking ability,
- Stabile stump volume,
- Standart stump lentgh,
Key exclusion criteria (3 listed)
- walking and other activities to prevent; shortness of muscle, limitation of joint motion and phantom pain in stump, presence of any discomfort or systemic health problem that may affect the gait outside the amputation
- presence of visual problems to prevent participation in virtual reality applications,
- use of walking aids
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 |
|---|---|---|
| ExerciseVirtual Reality Exercies | Other | Physio Therapy, Virtual Reality |
Primary outcome
Quality of Life measured of individuals: SF-36 Scale
Time frame: 10 minute
SF-36 Quality of Life Scale, higher values represent a better
Balance Test
Time frame: 5 minute
Single Leg Balance Test,higher values represent a better
Performance Test
Time frame: 6 minute
6 minute walk test,higher values represent a better
Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale
Time frame: 5 minute
Trinity Amputation Prothesis Experience Scale; 5 point likert scale,5-75 point, activity limitation,physicosocial adaptation,prothesis satisfaction
Gait Parameters
Time frame: 6 minute
Wearable Biometric Device
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 14 Mar 2019.
- Derived from this study: PubMed 37934289Yildirim Sahan T, Erbahceci F. Effects of Virtual Reality on Transtibial Amputation Rehabilitation Outcomes: A Randomized Study. Games Health J. 2023 Dec;12(6):459-467. doi: 10.1089/g4h.2023.0052. Epub 2023 Nov 7.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Virtual Reality, run by Hacettepe University.
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 6 inclusion and 3 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 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of Life measured of individuals: SF-36 Scale (time frame: 10 minute). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872193, which also lists 2 linked publications.
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 14 Mar 2019.