Transtibial AmputationEarly Phase 1NCT02328859
Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation
A Early Phase 1 study testing Virtual Reality Gait Training and Treadmill Gait Training in people with Transtibial Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Virtual Reality Gait Training and Treadmill Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 27 Jun 2017
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be unilateral transtibial amputees (TTA) between the ages of 18 and 65 who have consistently used a prosthesis for at least one year.
- Subjects must be community ambulators at a K3 level,
- which dictates that they have the ability or potential to walk with variable cadence,
- to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.
Who cannot join
- History of surgical procedures on their intact limb.
- Subjects will be excluded from the study if they present with
- cardiovascular,
- neurological,
- or balance disorders that can affect gait.
- Rheumatoid arthritis,
Show all 10Show fewer
- knee joint replacement,
- and the use of ambulatory aids will also exclude participation.
- Subjects with considerable pain in their knee joints, as measured by a visual analog scale will also be excluded due to the confounding effects of pain on gait patterns.
- A medical history screening will be used to identify subjects with pre-existing conditions that would compromise their gait.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Virtual Reality for Rehabilitation for Individuals With Lower Limb Amputation
A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. The treadmill is synchronized with an immersive display and an avatar of the user. The combination of variable terrain and visual feedback is extremely promising as a means for amputee patients to achieve improved functional mobility after gait training. The proposed work is relevant to public health because it is the first step in developing a novel rehabilitation system that will use visual feedback for gait training in amputees and others with pathological gait disorders. The research is pertinent to the mission of the Department of Veterans Affairs which is committed to improve the quality of life of Veterans with disability.
Read the detailed description
Lower extremity amputation can cause impairments in gait and balance due to the loss of proprioception and motor control. The asymmetries present during amputee gait are thought to be one of the major contributors to secondary musculoskeletal problems such as osteoarthritis. After lower extremity amputation, physical rehabilitation is necessary to achieve functional ambulation; however, no an evidence-based standard of care exists for individuals who undergo transtibial (TT) amputations. The objective of this application is to determine the effectiveness of gait training in an immersive virtual environment in people with transtibial amputation. The investigators' custom designed Virtual Gait Retraining System (VGRS) is a virtual reality (VR) system which provides visual and motor challenges while treadmill walking. The VGRS immerses the user in a virtual world, provides additional feedback with an avatar and presents the user with challenging tasks such as inclines and stair climbing which are complemented by the movement of the treadmill. The central hypothesis is that people with amputations will achieve greater improvements in balance, mobility and gait function using the investigators' custom designed VGRS as compared to current conventional treadmill gait training. This objective will be accomplished by addressing the following specific aims:
- 1) Compare the efficacy of VGRS to conventional treadmill training.
- 2) Evaluate the rate of improvement over the course of each training program (VGRS and conventional treadmill).
The investigators will conduct a randomized clinical trial with twenty TT amputee subjects comparing 6 weeks of training with the VGRS to 6 weeks of training using a conventional treadmill protocol. The investigators will use gait analysis, postural sway and standard balance and mobility instruments including the 6-Minute Walk Test, Four Square Step Test, the Berg Balance Scale and the Dynamic Gait Index to assess improvements in gait and mobility. The investigators will evaluate subject pre- and post training and at an interim point 3 weeks into the training sessions. The investigators anticipate that the VGRS will deliver more effective training by creating a realistic and challenging environment with accurate visual perception of a motor task which is being simultaneously performed by the user. The investigators will also gain an understanding of the rate of improvement for TT amputees during treadmill training. The research design will demonstrate the need for immersive virtual reality that includes a rich visual display and affords the opportunity to train on a variety of terrain conditions and mobility tasks.
- Conditions
- Transtibial Amputation
- Being tested
- Virtual Reality Gait Training, Treadmill Gait Training
- Keywords
- Gait, Rehabilitation, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Gait TrainingOther
A Virtual Gait Retraining System (VGRS) will be used to train amputees for six weeks. the system consists of an actuated treadmill, a virtual environment and an avatar
Treadmill Gait TrainingOther
A conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality gait rehabilitation | Experimental | Subjects will be trained using a custom treadmill with a virtual environment Receives: Other: Virtual Reality Gait Training |
| Treadmill training gait rehabilitation | Active comparator | Subjects wil be trained using a standard treadmill without any visual display Receives: Other: Treadmill Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Knee Joint Symmetry at 6 weeks
Knee joint symmetry will be determined by joint loading (knee joint moments). Changes in joint loading will be measured as the difference in knee joint moment between the left and right leg (measured in Newtons/meter/kilogram of body weight).
Measured: Baseline and at 6 weeks
Change from Baseline in Gait Speed (m/s) at 6 weeks
Gait speed (meters/second) will be measured while the participant is walking across a 40 foot walkway at a self selected speed
Measured: Baseline, at 3 weeks and at 6 weeks
Change from Baseline in Gait Variability at 3 weeks and 6 weeks
Gait variability will be determined by calculating the magnitude of stride-to -stride fluctuations, normalized to each subject's mean stride time to define the Coefficient of Variation
Measured: Baseline, at 3 weeks and at 6 weeks
Change from Baseline in Trunk Lean on the Prosthetic versus Non-Prosthetic Side of the Body (measured in degrees) at 6 weeks.
Gait symmetry will be determined by side to side trunk lean.
Measured: Baseline and at 6 weeks
Secondary outcomes (6)
Postural sway parameters - Swept Area - measured in meters x meters
To assess whole-body postural sway, displacement of the head-arm-trunk segment will be measured. The position of the center of mass (COM) of the body will be determined and the area swept by the COM will be calculated
Measured: Baseline and at 6 weeks
Berg Balance Scale - clinical evaluation - scored on a scale of 0 -4 with a maximum score of 56
The Berg Balance scale is used to measure balance by assessing the performance of functional tasks. Fourteen tasks are scored on a scale from 0 - 4 with 0 being less function and 4 reflecting the highest level of balance. Total score is 56.
41-56 = low fall risk 21-40 = moderate fall risk 0 - 20 = high fall risk
Measured: Baseline and at 6 weeks
Dynamic Gait Index - A four-point ordinal scale, ranging from 0-3 with a maximum score of 24.
Developed to assess the likelihood of a fall, the Dynamic Gait Index (DGI) is a four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Eight different tasks are scored and the maximum score obtainable is 24 point.
Interpretation: < 19/24 = predictive of falls; > 22/24 = safe ambulators
Measured: Baseline and at 6 weeks
Four Square Step Test - the time it takes to step in four squares backwards, sideways and forward. Measured in seconds.
Test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards
Measured: Baseline and at 6 weeks
Postural sway parameters - Mediolateral excursion of the center of mass measured in millimeters
The maximum excursions and standard deviations of the center of mass trajectory in the Mediolateral direction of the body will be measured.
Measured: Baseline and at 6 weeks
Postural sway parameters - Anteroposterior excursion of the center of mass measured in millimeters
The maximum excursions and standard deviations of the center of mass trajectory in the anteroposterior direction of the body will be measured.
Measured: Baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start1 Apr 2016
- Primary completion23 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan E D'Andrea, PhD MS BS, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328859
- Sponsor's protocol ID
- A1598-P
- Status last verified
- Oct 2019
- First submitted
- 9 Dec 2014
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
B 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 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Rehabilitation for Individuals With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT02328859
- Acronym / sponsor ID
- A1598-P
- Conditions
- Transtibial Amputation
- Keywords
- Gait, Rehabilitation, Virtual Reality
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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.
A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. The treadmill is synchronized with an immersive display and an avatar of the user. The combination of variable terrain and visual feedback is extremely promising as a means for amputee patients to achieve improved functional mobility after gait training. The proposed work is relevant to public health because it is the first step in developing a novel rehabilitation system that will use visual feedback for gait training in amputees and others with pathological gait disorders. The research is pertinent to the mission of the Department of Veterans Affairs which is committed to improve the quality of life of Veterans with disability.
Detailed description
Lower extremity amputation can cause impairments in gait and balance due to the loss of proprioception and motor control. The asymmetries present during amputee gait are thought to be one of the major contributors to secondary musculoskeletal problems such as osteoarthritis. After lower extremity amputation, physical rehabilitation is necessary to achieve functional ambulation; however, no an evidence-based standard of care exists for individuals who undergo transtibial (TT) amputations. The objective of this application is to determine the effectiveness of gait training in an immersive virtual environment in people with transtibial amputation. The investigators' custom designed Virtual Gait Retraining System (VGRS) is a virtual reality (VR) system which provides visual and motor challenges while treadmill walking. The VGRS immerses the user in a virtual world, provides additional feedback with an avatar and presents the user with challenging tasks such as inclines and stair climbing which are complemented by the movement of the treadmill. The central hypothesis is that people with amputations will achieve greater improvements in balance, mobility and gait function using the investigators' custom designed VGRS as compared to current conventional treadmill gait training. This objective will be accomplished by addressing the following specific aims:
- 1) Compare the efficacy of VGRS to conventional treadmill training.
- 2) Evaluate the rate of improvement over the course of each training program (VGRS and conventional treadmill).
The investigators will conduct a randomized clinical trial with twenty TT amputee subjects comparing 6 weeks of training with the VGRS to 6 weeks of training using a conventional treadmill protocol. The investigators will use gait analysis, postural sway and standard balance and mobility instruments including the 6-Minute Walk Test, Four Square Step Test, the Berg Balance Scale and the Dynamic Gait Index to assess improvements in gait and mobility. The investigators will evaluate subject pre- and post training and at an interim point 3 weeks into the training sessions. The investigators anticipate that the VGRS will deliver more effective training by creating a realistic and challenging environment with accurate visual perception of a motor task which is being simultaneously performed by the user. The investigators will also gain an understanding of the rate of improvement for TT amputees during treadmill training. The research design will demonstrate the need for immersive virtual reality that includes a rich visual display and affords the opportunity to train on a variety of terrain conditions and mobility tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality gait rehabilitation | Experimental | Other: Virtual Reality Gait TrainingSubjects will be trained using a custom treadmill with a virtual environment |
| Treadmill training gait rehabilitation | Active comparator | Other: Treadmill Gait TrainingSubjects wil be trained using a standard treadmill without any visual display |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be unilateral transtibial amputees (TTA) between the ages of 18 and 65 who have consistently used a prosthesis for at least one year.
- Subjects must be community ambulators at a K3 level,
Key exclusion criteria (10 listed)
- History of surgical procedures on their intact limb.
- Subjects will be excluded from the study if they present with
- Subjects with considerable pain in their knee joints, as measured by a visual analog scale will also be excluded due to the confounding effects of pain on gait patterns.
- A medical history screening will be used to identify subjects with pre-existing conditions that would compromise their gait.
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 |
|---|---|---|
| Virtual Reality Gait TrainingA Virtual Gait Retraining System (VGRS) will be used to train amputees for six weeks. the system consists of an actuated treadmill, a virtual environment and an avatar | Other | Virtual reality gait rehabilitation |
| Treadmill Gait TrainingA conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks. | Other | Treadmill training gait rehabilitation |
Primary outcome
Change from Baseline in Knee Joint Symmetry at 6 weeks
Time frame: Baseline and at 6 weeks
Knee joint symmetry will be determined by joint loading (knee joint moments). Changes in joint loading will be measured as the difference in knee joint moment between the left and right leg (measured in Newtons/meter/kilogram of body weight).
Change from Baseline in Gait Speed (m/s) at 6 weeks
Time frame: Baseline, at 3 weeks and at 6 weeks
Gait speed (meters/second) will be measured while the participant is walking across a 40 foot walkway at a self selected speed
Change from Baseline in Gait Variability at 3 weeks and 6 weeks
Time frame: Baseline, at 3 weeks and at 6 weeks
Gait variability will be determined by calculating the magnitude of stride-to -stride fluctuations, normalized to each subject's mean stride time to define the Coefficient of Variation
Change from Baseline in Trunk Lean on the Prosthetic versus Non-Prosthetic Side of the Body (measured in degrees) at 6 weeks.
Time frame: Baseline and at 6 weeks
Gait symmetry will be determined by side to side trunk lean.
6 secondary outcomes
Postural sway parameters - Swept Area - measured in meters x meters
Time frame: Baseline and at 6 weeks
Berg Balance Scale - clinical evaluation - scored on a scale of 0 -4 with a maximum score of 56
Time frame: Baseline and at 6 weeks
Dynamic Gait Index - A four-point ordinal scale, ranging from 0-3 with a maximum score of 24.
Time frame: Baseline and at 6 weeks
Four Square Step Test - the time it takes to step in four squares backwards, sideways and forward. Measured in seconds.
Time frame: Baseline and at 6 weeks
Postural sway parameters - Mediolateral excursion of the center of mass measured in millimeters
Time frame: Baseline and at 6 weeks
Postural sway parameters - Anteroposterior excursion of the center of mass measured in millimeters
Time frame: Baseline and at 6 weeks
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 24 Oct 2019.
- 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: Undecided
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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.
Susan E D'Andrea, PhD MS BS principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Reality Gait Training and Treadmill Gait Training in people with Transtibial Amputation, run by VA Office of Research and Development at 1 site in United States.
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 4 inclusion and 10 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 24 Oct 2019. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from Baseline in Knee Joint Symmetry at 6 weeks (time frame: Baseline and at 6 weeks). The study lists 4 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 NCT02328859, which also lists 1 linked publication.
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 24 Oct 2019.