Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation
|ClinicalTrials.gov Identifier: NCT02328859|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Transtibial Amputation||Other: Virtual Reality Gait Training Other: Treadmill Gait Training||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Virtual Reality for Rehabilitation for Individuals With Lower Limb Amputation|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||June 23, 2017|
|Actual Study Completion Date :||June 27, 2017|
Experimental: Virtual reality gait rehabilitation
Subjects will be trained using a custom treadmill with a virtual environment
Other: Virtual Reality Gait Training
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
Active Comparator: Treadmill training gait rehabilitation
Subjects wil be trained using a standard treadmill without any visual display
Other: Treadmill Gait Training
A conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks.
- 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.
- Postural sway parameters - Swept Area - measured in meters x meters [ 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
- 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 ]
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
- 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 ]
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
- 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 ]Test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards
- Postural sway parameters - Mediolateral excursion of the center of mass measured in millimeters [ 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.
- Postural sway parameters - Anteroposterior excursion of the center of mass measured in millimeters [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328859
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Susan E D'Andrea, PhD MS BS||Providence VA Medical Center, Providence, RI|