Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation

NCT02328859 | Completed Early Phase 1

• 1 other identifier: A1598-P
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputation

Keywords

Gait; Rehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (4)

• 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).

  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

  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

  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.

  Baseline and at 6 weeks

Secondary Outcomes (6)

• Postural sway parameters - Swept Area - measured in meters x meters

  Baseline and at 6 weeks

• Berg Balance Scale - clinical evaluation - scored on a scale of 0 -4 with a maximum score of 56

  Baseline and at 6 weeks

• Dynamic Gait Index - A four-point ordinal scale, ranging from 0-3 with a maximum score of 24.

  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.

  Baseline and at 6 weeks

• Postural sway parameters - Mediolateral excursion of the center of mass measured in millimeters

  Baseline and at 6 weeks

Study Arms (2)

Virtual reality gait rehabilitation

EXPERIMENTAL

Subjects will be trained using a custom treadmill with a virtual environment

Other: Virtual Reality Gait Training

Treadmill training gait rehabilitation

ACTIVE COMPARATOR

Subjects wil be trained using a standard treadmill without any visual display

Other: Treadmill Gait Training

Interventions

Virtual Reality Gait Training OTHER

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

Virtual reality gait rehabilitation

Treadmill Gait Training OTHER

A conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks.

Treadmill training gait rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

• 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.

  PMID: 37276273 DERIVED

Study Officials

• Susan E D'Andrea, PhD MS BS

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 31, 2014
• Study Start: April 1, 2016
• Primary Completion: June 23, 2017
• Study Completion: June 27, 2017
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)