Transtibial AmputationNCT02026570
Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.
A study testing Internal Focus of Attention and External Focus of Attention in people with Transtibial Amputation, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
Objectives: The purpose of this study is to investigate attentional (internal vs. external) focus effects on persons with amputation to perform a defined compensatory movement to reduce the likelihood of a fall. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Internal Focus of Attention and External Focus of Attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone amputation within the past year.
- 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.
Who cannot join
- Not cleared by Physical Therapy to use the prosthesis without contact precautions.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
V.A. Long Beach Healthcare System
Long Beach, California, 90822
About this study
Objectives: The purpose of this study is to investigate attentional (internal vs. external) focus effects on persons with amputation to perform a defined compensatory movement to reduce the likelihood of a fall. An internal focus of attention directs a person's conscious attention to their body's movements, whereas an external focus of attention directs a person's conscious attention to the effects of their movements or specific features in the environment. Numerous experiments have investigated the effects of an internal and external focus of attention on motor performance and the findings are in favor of an external focus of attention. In our work, we propose a motor learning research experiment to evaluate attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the new proprioceptive information for persons with a recent transtibial amputation.
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.
Read more
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.
- Conditions
- Transtibial Amputation
- Being tested
- Internal Focus of Attention, External Focus of Attention
- Keywords
- Prosthesis, Falls, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Focus of AttentionBehavioural
Providing instructions for the user to manipulate their residual limb in space during standing and walking tasks.
External Focus of AttentionBehavioural
Providing instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Persons with unilateral transtibial amputation receiving standard physical therapy. |
| Motor Control Internal Focus | Experimental | Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with motor control internal focus of attention instructions. Receives: Behavioral: Internal Focus of Attention |
| Motor Control External Focus | Experimental | Persons with unilateral transtibial amputation receiving standard physical therapy and additional training with external focus of attention instructions. Receives: Behavioral: External Focus of Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time
Time for subject to laterally displace Center of Mass two standard deviations from normative trajectory following stimulus.
Measured: Five visits over a three week period.
Secondary outcomes (1)
Movement Time
Time from reaction time to completion of task, which is a side step following stimulus.
Measured: Five visits over a three week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- California State University, Long Beach, California State University, Dominguez Hills
- Responsible party
- Principal investigator, Dana Craig, Southern California Institute for Research and Education
- Investigators
- Dana D. Craig, M.A., Principal investigator, V.A. Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026570
- Sponsor's protocol ID
- 01234
- Status last verified
- Apr 2019
- First submitted
- 19 Dec 2013
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7105581D. 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.
PubMed 6527290Fan 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.
PubMed 18586606Kaczmarek 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.
PubMed 2026426Kadkade 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.
PubMed 14960115G.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.
PubMed 11494181J.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.
PubMed 11848583Yoshida 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.
PubMed 8682528D. 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.
- ClinicalTrials.gov ID
- NCT02026570
- Acronym / sponsor ID
- 01234
- Conditions
- Transtibial Amputation
- Keywords
- Prosthesis, Falls, Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- California State University, Long Beach, California State University, Dominguez Hills
- Study start
- Jun 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2019 (estimated)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The purpose of this study is to investigate attentional (internal vs. external) focus effects on persons with amputation to perform a defined compensatory movement to reduce the likelihood of a fall. An internal focus of attention directs a person's conscious attention to their body's movements, whereas an external focus of attention directs a person's conscious attention to the effects of their movements or specific features in the environment. Numerous experiments have investigated the effects of an internal and external focus of attention on motor performance and the findings are in favor of an external focus of attention. In our work, we propose a motor learning research experiment to evaluate attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the new proprioceptive information for persons with a recent transtibial amputation.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Persons with unilateral transtibial amputation receiving standard physical therapy. |
| Motor Control Internal Focus | Experimental | Behavioral: Internal Focus of AttentionPersons with unilateral transtibial amputation receiving standard physical therapy and additional training with motor control internal focus of attention instructions. |
| Motor Control External Focus | Experimental | Behavioral: External Focus of AttentionPersons with unilateral transtibial amputation receiving standard physical therapy and additional training with external focus of attention instructions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergone amputation within the past year.
- 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.
Key exclusion criteria (2 listed)
- Not cleared by Physical Therapy to use the prosthesis without contact precautions.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Focus of AttentionProviding instructions for the user to manipulate their residual limb in space during standing and walking tasks. | Behavioural | Motor Control Internal Focus |
| External Focus of AttentionProviding instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks. | Behavioural | Motor Control External Focus |
Primary outcome
Reaction Time
Time frame: Five visits over a three week period.
Time for subject to laterally displace Center of Mass two standard deviations from normative trajectory following stimulus.
1 secondary outcome
Movement Time
Time frame: Five visits over a three week period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 7105581Clippinger 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.
- BackgroundD. 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.
- Background: PubMed 6527290Doubler JA, Childress DS. An analysis of extended physiological proprioception as a prosthesis-control technique. J Rehabil Res Dev. 1984 May;21(1):5-18.
- Background: PubMed 18586606Fan 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.
- Background: PubMed 2026426Kaczmarek 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.
- Background: PubMed 14960115Kadkade 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.
- BackgroundG.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
- Background: PubMed 11494181Miller 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.
- BackgroundJ.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
- BackgroundJ.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
- BackgroundD.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
- BackgroundD.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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana D. Craig, M.A. principal investigator
V.A. Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Focus of Attention and External Focus of Attention in people with Transtibial Amputation, run by Southern California Institute for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time (time frame: Five visits over a three week period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026570, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.