Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908, United States
NCT Number: NCT02328859
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.
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Notify Me18 year–65 year
All sexes
Interventional
Early Phase 1
Providence, Rhode Island, 02908, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
A conventional treadmill with no visual display will be used to gait train amputees for a period of six 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).
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
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
Time frame: Baseline and at 6 weeks
Gait symmetry will be determined by side to side trunk lean.
Time frame: Baseline and at 6 weeks
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
Time frame: Baseline and at 6 weeks
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
Time frame: Baseline and at 6 weeks
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
Time frame: Baseline and at 6 weeks
Test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards
Time frame: Baseline and at 6 weeks
The maximum excursions and standard deviations of the center of mass trajectory in the Mediolateral direction of the body will be measured.
Time frame: Baseline and at 6 weeks
The maximum excursions and standard deviations of the center of mass trajectory in the anteroposterior direction of the body will be measured.
VA Office of Research and Development
Fed
Virtual Reality for Rehabilitation for Individuals With Lower Limb Amputation
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