Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.
NCT ID: NCT02026570
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
6 participants
INTERVENTIONAL
2013-06-30
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Research Design and Methodology: For this pilot study, six participants with recent unilateral transtibial amputation will be recruited. Four participants will receive internal and external focus of attention training methods while the other two (control group) will receive standard prosthetic training instructions. The experiment will be conducted in three phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 - Learning Test. The training will utilize a vibrotactile device designed to generate tactile sensations at the skin-socket interface simulating contact of the prosthesis with the environment. The sensation simulates a perturbation that signals a potential fall event. During the experiment the augmented sensory information will be introduced randomly while participants walk at a preferred pace on a level surface. Movement kinematics and kinetics of the body will be recorded for analyses using a motion capture system with force plates.
Finding: It is hypothesized that the external focus of attention condition will outperform the internal focus of attention condition when responding to perturbations. The external focus of attention condition will yield faster response time and show improved compensatory responses compared to the internal focus of attention group by producing a greater lateral displacement of the artificial limb relative to the line of progression. In addition, the external condition will demonstrate a greater step length and step height than the internal focus of attention condition when provided with a perturbation.
Clinical Significance: Current practices within the field of Physical Therapy reveal that there is little therapeutic intervention for fall prevention. Instructions are traditionally provided on how to reduce the risk of falling through preparation of a room or obstacle avoidance or on the proper way to fall to decrease injury. However, there are no protocols for providing a prosthetic user with compensatory strategies to avoid a fall after a perturbation occurs. The research findings can result in improved training protocols, which can improve rehabilitative outcome.
Impact/Significance: The growing number of prosthetic users presents a need for improved patient care and effective prosthetic training and rehabilitation methods. Complimentary to the mission of the VA, the results of this research could enhance the quality of patient care and further assist these patients toward becoming prosthetically rehabilitated.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gait Perturbations to Improve Balance Post-stroke
NCT04314830
Improving Propulsion of the Paretic Leg In Chronic Stroke
NCT04650802
Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
NCT07057700
Balance Rehabilitation With Sensory Recalibration After Stroke
NCT01677091
Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
NCT02096367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Persons with unilateral transtibial amputation receiving standard physical therapy.
No interventions assigned to this group
Motor Control Internal Focus
Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with motor control internal focus of attention instructions.
Internal Focus of Attention
Providing instructions for the user to manipulate their residual limb in space during standing and walking tasks.
Motor Control External Focus
Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with external focus of attention instructions.
External Focus of Attention
Providing instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Internal Focus of Attention
Providing instructions for the user to manipulate their residual limb in space during standing and walking tasks.
External Focus of Attention
Providing instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Currently undergoing prosthetic training in Physical Therapy utilizing a prosthesis.
* Be within two weeks of completing prosthetic training in Physical Therapy.
* Ability to tolerate walking for a minimum of 100 yards over the course of a four hour time period with or without resting.
* No current skin breakdown on the residual limb.
Exclusion Criteria
* Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California State University, Long Beach
OTHER
California State University, Dominguez Hills
OTHER
Southern California Institute for Research and Education
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dana Craig
Health System Specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dana D. Craig, M.A.
Role: PRINCIPAL_INVESTIGATOR
V.A. Long Beach Healthcare System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
V.A. Long Beach Healthcare System
Long Beach, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Clippinger FW, Seaber AV, McElhaney JH, Harrelson JM, Maxwell GM. Afferent sensory feedback for lower extremity prosthesis. Clin Orthop Relat Res. 1982 Sep;(169):202-6.
D. J. DiLorenzo, D. J. Edell, M. J. Koris, and R. R. Riso, "Chronic intraneural electrical stimulation for prosthetic sensory feedback," 1st IEEE EMBS Conference on Neural Engineering, pp:116-119, 2003.
Doubler JA, Childress DS. An analysis of extended physiological proprioception as a prosthesis-control technique. J Rehabil Res Dev. 1984 May;21(1):5-18.
Fan RE, Culjat MO, King CH, Franco ML, Boryk R, Bisley JW, Dutson E, Grundfest WS. A haptic feedback system for lower-limb prostheses. IEEE Trans Neural Syst Rehabil Eng. 2008 Jun;16(3):270-7. doi: 10.1109/TNSRE.2008.920075.
Kaczmarek KA, Webster JG, Bach-y-Rita P, Tompkins WJ. Electrotactile and vibrotactile displays for sensory substitution systems. IEEE Trans Biomed Eng. 1991 Jan;38(1):1-16. doi: 10.1109/10.68204.
Kadkade PP, Benda BJ, Schmidt PB, Wall C 3rd. Vibrotactile display coding for a balance prosthesis. IEEE Trans Neural Syst Rehabil Eng. 2003 Dec;11(4):392-9. doi: 10.1109/TNSRE.2003.819937.
G.E. Loeb and F.J. Richmond. BION Implants for Therapeutic and Functional Electrical Stimulation. Neural Prostheses for Restoration of Sensor and Motor Function. CRC Press, Boca Raton, FL, 2000. R.A. Magill. "Motor Learning and Control: Concepts and Applications," (9th ed.). New York, NY: McGraw Hill, 2011
Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.
J.A. Sabolich and G.M. Ortega. "Sense of feel for lower-limb amputees: A phase-one study," Journal of Prosthetics and Orthotics, 6(2):36-41, 1994
J.A. Sabolich, G.M. Ortega, and G.B. Schwabe. "System and method for providing a sense of feel in a prosthetic or sensory impaired limb," United States Patent, December 31, 2002
D.C. Simpson. "The choice of control system for the multimovement prosthesis: extended physiological proprioception (EPP), " In: The Control of Upper-Extremity Prostheses and Orthoses. Springfiled, Illinois, C.C Thomas. pp:146-150, 1974
D.C. Simpson. "The control and supply of a multimovement externally powered upper limb prosthesis," Proc 4th Ini Symp External Control of Human Extremities. Belgrade, Yugoslav Committee for Electronics and Autotlon. pp:247-254, 1973
Wulf G, Prinz W. Directing attention to movement effects enhances learning: a review. Psychon Bull Rev. 2001 Dec;8(4):648-60. doi: 10.3758/bf03196201.
Yoshida K, Horch K. Closed-loop control of ankle position using muscle afferent feedback with functional neuromuscular stimulation. IEEE Trans Biomed Eng. 1996 Feb;43(2):167-76. doi: 10.1109/10.481986.
D. Zambarbieri, M. Schmid, and G. Verni. "Sensory feedback for lower limb prosthesis", in Intelligent Systems and Technologies in Rehabilitation Engineering, Ed. H.L. Teodorescu and L. Jain, CRC Press, Boca Raton, 2001
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01234
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.