Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328859
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Transtibial Amputation Other: Virtual Reality Gait Training Other: Treadmill Gait Training Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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


  4. 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

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328859


Locations
Layout table for location information
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Susan E D'Andrea, PhD MS BS Providence VA Medical Center, Providence, RI
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02328859    
Other Study ID Numbers: A1598-P
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Gait
Rehabilitation
Virtual Reality