Phantom LimbNCT05247827
The Effects of Targeted Phantom Motor Execution on Phantom Limb Control
A study testing Targeted phantom limb motor execution (exercise) in people with Phantom Limb and Motor Activity, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Lower limb amputations account for more than 85% of all amputations. In Canada, it has been reported that transtibial amputation (TTA) is the most common level of amputation. Many people with limb amputation have awareness and feel that their missing limb still exists (phantom limb), with perceptions of sensation or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb, Motor Activity, Amputation Stump
- What is being tested?
- Targeted phantom limb motor execution (exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Amputation surgery in Manitoba
- Amputation surgery at least 6 months ago
- Unilateral TTA
- Existence of mature and wound-free residual limb
- Experience of walking with a prosthesis for at least five months
Show all 11Show fewer
- Having contralateral healthy foot with no wounds, ulcers, abrasions, or loss of toes
- Ability to walk independently for two minutes with/without an assistive device
- Presence of PLA
- Ability to read, write, and understand instructions and questionnaires in English
- Have the dexterity to use a computer, tablet, or smartphone and the ability to communicate through Zoom application.
Who cannot join
- Existence of psychological or psychiatric conditions (e.g. depression or anxiety) that negatively impact daily life
- Addiction to alcohol or drug
- Any medical condition that might conceivably alter how a person perceives the body or their ability to execute movements
- Inability to move the intact limb at the foot and ankle joints
- Fluctuating doses of pain suppressing medications in the previous month
- Receiving formal training on exercising phantom limb
- Existence of severe pain that limits activity
- Undergoing prosthetic adjustments (e.g. in socket fit, components, alignment) in the past five months or plan to have prosthetic adjustments over the study period
Trial locations and contacts
1 site in 1 country.
Canada1 site
Winnipeg Prosthetics and Orthotics (WinPO) Clinic
Winnipeg, Manitoba, R2H 0T6
About this study
Official title: The Effects of Targeted Phantom Motor Execution, Prosthetic Embodiment, and Surgical Closure on Phantom Limb Control, and Physical Function in People With Unilateral (Single) Transtibial (Below-the-knee) Amputation
Lower limb amputations account for more than 85% of all amputations. In Canada, it has been reported that transtibial amputation (TTA) is the most common level of amputation. Many people with limb amputation have awareness and feel that their missing limb still exists (phantom limb), with perceptions of sensation or pain, and the ability to move the limb with or without intention. Phantom limb sensation (PLS) is defined as all non-painful somatic sensations (e.g. sense of the limb position, touch, pressure, warmth or cold, or movement) in the missing part of the limb. The incidence of PLS is about 60% in adults after 17 months. In addition to PLS, 60-70% of people with amputation experience phantom limb pain (PLP), an intense chronic pain perception in their phantom limb, in the first year after amputation. Although PLP is well known to decrease the quality of life and lessen function, little is known about PLS and phantom limb control (PLC), the ability to intentionally move or control movements of the phantom limb. Enhancing PLS and PLC especially in the immediate months after amputation, could decrease painful perception, facilitate prosthetic control, and improve the function of people with amputations. Keeping this therapeutic and rehabilitative significance in mind, it is hypothesized that a targeted program of phantom motor execution, designed to address phantom limb awareness (PLA), the general knowledge of the presence or existence of the missing limb as one's own, could be associated with improving PLC in people with TTA. Furthermore, prosthetic embodiment, the sense that the prosthesis is accepted as a part of the body with the same functional abilities, may play a role in PLC. Investigating the association of PLC, as one of the phantom phenomena (i.e. PLA, PLS, PLP, and PLC), with surgical, clinical, and demographic characteristics of people with TTA will provide better insight into how phantom phenomena develop. The association of PLC with physical function has significant clinical importance that has never been investigated in people with TTA.
Read the detailed description
This research explores testing of the following hypotheses with four independent but interrelated studies:
Study #1:
In people with TTA, post-amputation exercises focus on strength, balance, flexibility, and endurance training of the residual limb and intact limb muscles. Phantom limb motor execution, the active movement of the amputated body part, is not usually encouraged until a patient complains of PLP with the hypothesis that this intervention could re-organize the motor cortex to pre-amputation neural network and function. It was shown that phantom motor execution promoted by mirror therapy, virtual reality, and augmented reality could be used as a non-invasive therapy to relieve PLP in people with limb amputation. However, it is not clear if training with phantom motor execution improves peripheral control over the phantom limb. Therefore, this study explores the effects of a targeted phantom motor execution program on PLC in people with unilateral TTA.
Specific aim: To determine if targeted phantom motor execution improves control of the phantom limb, as measured by EMG patterning, in people with unilateral TTA.
Research hypothesis: People with unilateral TTA will improve control of their phantom limb after completion of a targeted phantom motor execution program.
Study #2:
Prosthetic embodiment is a sense that people with limb amputation feel that their prosthesis is integrated into their body and acts like their limb before amputation. It has been shown that higher prosthesis embodiment is associated with less PLP with the thought that it reverses brain plasticity after amputation. It is not clear whether prosthetic embodiment has any effect on PLC. This study explores the potential association between prosthetic embodiment and PLC in people with unilateral TTA.
Specific aim: To determine if there is a correlation between prosthetic embodiment, as measured by the self-reported TAPES-R and PEmbS-LLA questionnaires, and PLC (self-report), in people with unilateral TTA.
Research hypothesis: There is a strong positive association between prosthetic embodiment and PLC in people with unilateral TTA.
Study #3:
Surgical closure of the dissected muscles of the residual limb has been shown to impact PLP in people with limb amputation. The two most common surgical closure techniques are myodesis connection of the dissected muscles to bone/periosteum, and myoplasty, the connection of the dissected muscles to antagonist muscles. Residual limb muscles activity and PLA could be influenced by the distal closure of the dissected muscles. However, there is a scarcity of evidence on how surgical closure impacts the PLC. This study explores the association of surgical closure with PLC by measuring the symmetry of EMG muscle activity between the amputated and intact sides in people with unilateral TTA.
Specific aim: To determine if PLC, as measured by the symmetry of EMG muscle activity, is influenced by the surgical closure technique of the dissected muscles.
Research hypothesis: People who undergo unilateral TTA and myodesis surgical closure of the dissected muscles will have better PLC, as measured by the symmetry of EMG muscle activity, than those who undergo unilateral TTA and myoplasty surgical closure of the dissected muscles.
Study #4:
The previous three studies investigate the effects of the targeted phantom motor execution, prosthetic embodiment, and surgical closure on PLC. In the literature, it has been shown that improvement of PLC has been correlated with decreased PLP, and reduced PLP is associated with better function in people with limb amputation. However, it is not clear whether PLC has an association with physical function in people with TTA.
Specific aim: To determine if there is a correlation between PLC (self-report) and physical function, as measured by the four-square step test (FSST), in people with unilateral TTA.
Research hypothesis: There is a strong positive association between PLC and physical function in people with unilateral TTA.
- Conditions
- Phantom Limb, Motor Activity, Amputation Stump, Amputation
- Being tested
- Targeted phantom limb motor execution (exercise)
- Keywords
- Prosthetic embodiment, Surgical closure, Phantom limb control, Physical function
- Medical subject headings
- Phantom Limb, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted phantom limb motor execution (exercise)Other
The targeted phantom motor execution is a specific training program for people with TTA that has been designed to improve the muscles' strength, coordination, and flexibility at the amputated and contralateral intact sides. Such training consists of repeated short-term, short rest interval, and moderate-intensity exercises (Schoenfeld 2010, Krutki, Mrowczynski et al. 2017). Targeted phantom motor execution can improve the body image considering its induced muscular impacts. People with TTA will be trained to follow specific movements of their foot-ankle complexes simultaneously, in order to increase PLA, as well as induce muscular morphologic and brain neuroplastic changes (Moseley and Brugger 2009).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will receive usual and customary post-amputation treatment |
| Exercise Group | Experimental | Participants will be trained for 3 consecutive weeks to perform the targeted exercise of their phantom limb in addition to receiving usual and customary post-amputation treatment. Receives: Other: Targeted phantom limb motor execution (exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phantom limb control as measured by EMG patterning
The ability to intentionally move or control movements of the phantom limb
Measured: 1 year (March 2022 - March 2023)
Prosthetic embodiment as measured by "Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)"
The sense that people with limb amputation feel that their prosthesis is integrated to their body and acts like their limb before amputation
Measured: 1 year (March 2022 - March 2023)
Prosthetic embodiment as measured by "Prosthesis Embodiment Scale for Lower Limb Amputees (PEmbS-LLA)"
The sense that people with limb amputation feel that their prosthesis is integrated to their body and acts like their limb before amputation
Measured: 1 year (March 2022 - March 2023)
Time score for four-square step test (s)
The fastest time required to pass through a sequence of 4 squares without touching the two crossing sticks that make those 4 squares. Both feet must make contact with the floor in each square while the person is face forward during the entire test.
Measured: 1 year (March 2022 - March 2023)
Secondary outcomes (4)
Amplitude of electromyography (EMG) of the agonist and antagonist muscles's activity
The maximum voltage of the EMG signal during activity of the agonist and antagonist muscles (i.e. Tibialis anterior, and Medial and Lateral Gastrocnemius) during targeted phantom motor executions
Measured: 1 year (March 2022 - March 2023)
Frequency of electromyography (EMG) of the agonist and antagonist muscles's activity
The rate of EMG signal oscillation during activity of the agonist and antagonist muscles (i.e. Tibialis anterior, and Medial and Lateral Gastrocnemius) during targeted phantom motor executions
Measured: 1 year (March 2022 - March 2023)
Index of electromyography (EMG) co-activation of the agonist and antagonist muscles
The amount of closeness of the EMG signal frequency of the agonist muscles to that of the antagonist muscles (the rate of EMG frequency of the agonist to that of the antagonist muscles' activity) during targeted phantom motor executions
Measured: 1 year (March 2022 - March 2023)
Foot plantar load (N)
The measured load under the heel, midfoot, and toes of the foot during targeted phantom motor execution when measured by Loadsol insoles
Measured: 1 year (March 2022 - March 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Phantom LimbStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Audrey Zucker-Levin, University of Saskatchewan
- Investigators
- Audrey Zucker-Levin, Professor, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247827
- Sponsor's protocol ID
- Bio 2855
- Status last verified
- Dec 2023
- First submitted
- 25 Jan 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In Saskatchewan and Manitoba, the Health Information Protection Act (HIPA) defines how the privacy of participants' personal health information must be maintained so that their privacy and confidentiality will be respected. No information that discloses participant identity will be released or published without the participant's specific consent to the disclosure. However, research records and medical records identifying participants may be inspected in the presence of the principal investigator by the University of Saskatchewan Research Ethics Board for the purpose of monitoring the research. However, no records, which identify a participant by name or initials, will be allowed to leave the principal investigator's office. The results of this study may be presented in a scientific meeting or published, but the participants' identities will not be disclosed.
Publications
Bekrater-Bodmann R, Reinhard I, Diers M, Fuchs X, Flor H. Relationship of prosthesis ownership and phantom limb pain: results of a survey in 2383 limb amputees. Pain. 2021 Feb 1;162(2):630-640. doi: 10.1097/j.pain.0000000000002063.
PubMed 32868751Brodie EE, Whyte A, Niven CA. Analgesia through the looking-glass? A randomized controlled trial investigating the effect of viewing a 'virtual' limb upon phantom limb pain, sensation and movement. Eur J Pain. 2007 May;11(4):428-36. doi: 10.1016/j.ejpain.2006.06.002. Epub 2006 Jul 20.
PubMed 16857400Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
PubMed 12551807Flor H, Nikolajsen L, Staehelin Jensen T. Phantom limb pain: a case of maladaptive CNS plasticity? Nat Rev Neurosci. 2006 Nov;7(11):873-81. doi: 10.1038/nrn1991.
PubMed 17053811Geertzen JHB, van der Schans SM, Jutte PC, Kraeima J, Otten E, Dekker R. Myodesis or myoplasty in trans-femoral amputations. What is the best option? An explorative study. Med Hypotheses. 2019 Mar;124:7-12. doi: 10.1016/j.mehy.2019.01.008. Epub 2019 Jan 16. No abstract available.
PubMed 30798921Hunter JP, Katz J, Davis KD. The effect of tactile and visual sensory inputs on phantom limb awareness. Brain. 2003 Mar;126(Pt 3):579-89. doi: 10.1093/brain/awg054.
PubMed 12566279Hunter JP, Katz J, Davis KD. Stability of phantom limb phenomena after upper limb amputation: a longitudinal study. Neuroscience. 2008 Oct 28;156(4):939-49. doi: 10.1016/j.neuroscience.2008.07.053. Epub 2008 Aug 3.
PubMed 18755249Imam B, Miller WC, Finlayson HC, Eng JJ, Jarus T. Incidence of lower limb amputation in Canada. Can J Public Health. 2017 Nov 9;108(4):e374-e380. doi: 10.17269/cjph.108.6093.
PubMed 29120308Kilteni K, Groten R, Slater M. The Sense of Embodiment in Virtual Reality. Presence: Teleoperators and Virtual Environments. 2012; 21(4): 373-387.
Krutki P, Mrowczynski W, Baczyk M, Lochynski D, Celichowski J. Adaptations of motoneuron properties after weight-lifting training in rats. J Appl Physiol (1985). 2017 Sep 1;123(3):664-673. doi: 10.1152/japplphysiol.00121.2017. Epub 2017 Jun 8.
PubMed 28596267Marshall HM, Jensen MP, Ehde DM, Campbell KM. Pain site and impairment in individuals with amputation pain. Arch Phys Med Rehabil. 2002 Aug;83(8):1116-9. doi: 10.1053/apmr.2002.33121.
PubMed 12161833Matjacic Z, Burger H. Dynamic balance training during standing in people with trans-tibial amputation: a pilot study. Prosthet Orthot Int. 2003 Dec;27(3):214-20. doi: 10.1080/03093640308726684.
PubMed 14727702Montoya P, Larbig W, Grulke N, Flor H, Taub E, Birbaumer N. The relationship of phantom limb pain to other phantom limb phenomena in upper extremity amputees. Pain. 1997 Aug;72(1-2):87-93. doi: 10.1016/s0304-3959(97)00004-3.
PubMed 9272791Moseley GL, Brugger P. Interdependence of movement and anatomy persists when amputees learn a physiologically impossible movement of their phantom limb. Proc Natl Acad Sci U S A. 2009 Nov 3;106(44):18798-802. doi: 10.1073/pnas.0907151106. Epub 2009 Oct 26.
PubMed 19858475Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
PubMed 27916234
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Targeted Phantom Motor Execution, Prosthetic Embodiment, and Surgical Closure on Phantom Limb Control, and Physical Function in People With Unilateral (Single) Transtibial (Below-the-knee) Amputation
- ClinicalTrials.gov ID
- NCT05247827
- Acronym / sponsor ID
- Bio 2855
- Conditions
- Phantom Limb, Motor Activity, Amputation Stump, Amputation
- Keywords
- Prosthetic embodiment, Surgical closure, Phantom limb control, Physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Feb 2022 (actual)
- 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.
Lower limb amputations account for more than 85% of all amputations. In Canada, it has been reported that transtibial amputation (TTA) is the most common level of amputation. Many people with limb amputation have awareness and feel that their missing limb still exists (phantom limb), with perceptions of sensation or pain, and the ability to move the limb with or without intention. Phantom limb sensation (PLS) is defined as all non-painful somatic sensations (e.g. sense of the limb position, touch, pressure, warmth or cold, or movement) in the missing part of the limb. The incidence of PLS is about 60% in adults after 17 months. In addition to PLS, 60-70% of people with amputation experience phantom limb pain (PLP), an intense chronic pain perception in their phantom limb, in the first year after amputation. Although PLP is well known to decrease the quality of life and lessen function, little is known about PLS and phantom limb control (PLC), the ability to intentionally move or control movements of the phantom limb. Enhancing PLS and PLC especially in the immediate months after amputation, could decrease painful perception, facilitate prosthetic control, and improve the function of people with amputations. Keeping this therapeutic and rehabilitative significance in mind, it is hypothesized that a targeted program of phantom motor execution, designed to address phantom limb awareness (PLA), the general knowledge of the presence or existence of the missing limb as one's own, could be associated with improving PLC in people with TTA. Furthermore, prosthetic embodiment, the sense that the prosthesis is accepted as a part of the body with the same functional abilities, may play a role in PLC. Investigating the association of PLC, as one of the phantom phenomena (i.e. PLA, PLS, PLP, and PLC), with surgical, clinical, and demographic characteristics of people with TTA will provide better insight into how phantom phenomena develop. The association of PLC with physical function has significant clinical importance that has never been investigated in people with TTA.
Detailed description
This research explores testing of the following hypotheses with four independent but interrelated studies:
Study #1:
In people with TTA, post-amputation exercises focus on strength, balance, flexibility, and endurance training of the residual limb and intact limb muscles. Phantom limb motor execution, the active movement of the amputated body part, is not usually encouraged until a patient complains of PLP with the hypothesis that this intervention could re-organize the motor cortex to pre-amputation neural network and function. It was shown that phantom motor execution promoted by mirror therapy, virtual reality, and augmented reality could be used as a non-invasive therapy to relieve PLP in people with limb amputation. However, it is not clear if training with phantom motor execution improves peripheral control over the phantom limb. Therefore, this study explores the effects of a targeted phantom motor execution program on PLC in people with unilateral TTA.
Specific aim: To determine if targeted phantom motor execution improves control of the phantom limb, as measured by EMG patterning, in people with unilateral TTA.
Research hypothesis: People with unilateral TTA will improve control of their phantom limb after completion of a targeted phantom motor execution program.
Study #2:
Prosthetic embodiment is a sense that people with limb amputation feel that their prosthesis is integrated into their body and acts like their limb before amputation. It has been shown that higher prosthesis embodiment is associated with less PLP with the thought that it reverses brain plasticity after amputation. It is not clear whether prosthetic embodiment has any effect on PLC. This study explores the potential association between prosthetic embodiment and PLC in people with unilateral TTA.
Specific aim: To determine if there is a correlation between prosthetic embodiment, as measured by the self-reported TAPES-R and PEmbS-LLA questionnaires, and PLC (self-report), in people with unilateral TTA.
Research hypothesis: There is a strong positive association between prosthetic embodiment and PLC in people with unilateral TTA.
Study #3:
Surgical closure of the dissected muscles of the residual limb has been shown to impact PLP in people with limb amputation. The two most common surgical closure techniques are myodesis connection of the dissected muscles to bone/periosteum, and myoplasty, the connection of the dissected muscles to antagonist muscles. Residual limb muscles activity and PLA could be influenced by the distal closure of the dissected muscles. However, there is a scarcity of evidence on how surgical closure impacts the PLC. This study explores the association of surgical closure with PLC by measuring the symmetry of EMG muscle activity between the amputated and intact sides in people with unilateral TTA.
Specific aim: To determine if PLC, as measured by the symmetry of EMG muscle activity, is influenced by the surgical closure technique of the dissected muscles.
Research hypothesis: People who undergo unilateral TTA and myodesis surgical closure of the dissected muscles will have better PLC, as measured by the symmetry of EMG muscle activity, than those who undergo unilateral TTA and myoplasty surgical closure of the dissected muscles.
Study #4:
The previous three studies investigate the effects of the targeted phantom motor execution, prosthetic embodiment, and surgical closure on PLC. In the literature, it has been shown that improvement of PLC has been correlated with decreased PLP, and reduced PLP is associated with better function in people with limb amputation. However, it is not clear whether PLC has an association with physical function in people with TTA.
Specific aim: To determine if there is a correlation between PLC (self-report) and physical function, as measured by the four-square step test (FSST), in people with unilateral TTA.
Research hypothesis: There is a strong positive association between PLC and physical function in people with unilateral TTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will receive usual and customary post-amputation treatment |
| Exercise Group | Experimental | Other: Targeted phantom limb motor execution (exercise)Participants will be trained for 3 consecutive weeks to perform the targeted exercise of their phantom limb in addition to receiving usual and customary post-amputation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- Amputation surgery in Manitoba
- Amputation surgery at least 6 months ago
- Unilateral TTA
- Existence of mature and wound-free residual limb
Key exclusion criteria (8 listed)
- Existence of psychological or psychiatric conditions (e.g. depression or anxiety) that negatively impact daily life
- Addiction to alcohol or drug
- Any medical condition that might conceivably alter how a person perceives the body or their ability to execute movements
- Inability to move the intact limb at the foot and ankle joints
- Fluctuating doses of pain suppressing medications in the previous month
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 |
|---|---|---|
| Targeted phantom limb motor execution (exercise)The targeted phantom motor execution is a specific training program for people with TTA that has been designed to improve the muscles' strength, coordination, and flexibility at the amputated and contralateral intact sides. Such training consists of repeated short-term, short rest interval, and moderate-intensity exercises (Schoenfeld 2010, Krutki, Mrowczynski et al. 2017). Targeted phantom motor execution can improve the body image considering its induced muscular impacts. People with TTA will be trained to follow specific movements of their foot-ankle complexes simultaneously, in order to increase PLA, as well as induce muscular morphologic and brain neuroplastic changes (Moseley and Brugger 2009). | Other | Exercise Group |
Primary outcome
Phantom limb control as measured by EMG patterning
Time frame: 1 year (March 2022 - March 2023)
The ability to intentionally move or control movements of the phantom limb
Prosthetic embodiment as measured by "Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)"
Time frame: 1 year (March 2022 - March 2023)
The sense that people with limb amputation feel that their prosthesis is integrated to their body and acts like their limb before amputation
Prosthetic embodiment as measured by "Prosthesis Embodiment Scale for Lower Limb Amputees (PEmbS-LLA)"
Time frame: 1 year (March 2022 - March 2023)
The sense that people with limb amputation feel that their prosthesis is integrated to their body and acts like their limb before amputation
Time score for four-square step test (s)
Time frame: 1 year (March 2022 - March 2023)
The fastest time required to pass through a sequence of 4 squares without touching the two crossing sticks that make those 4 squares. Both feet must make contact with the floor in each square while the person is face forward during the entire test.
4 secondary outcomes
Amplitude of electromyography (EMG) of the agonist and antagonist muscles's activity
Time frame: 1 year (March 2022 - March 2023)
Frequency of electromyography (EMG) of the agonist and antagonist muscles's activity
Time frame: 1 year (March 2022 - March 2023)
Index of electromyography (EMG) co-activation of the agonist and antagonist muscles
Time frame: 1 year (March 2022 - March 2023)
Foot plantar load (N)
Time frame: 1 year (March 2022 - March 2023)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 32868751Bekrater-Bodmann R, Reinhard I, Diers M, Fuchs X, Flor H. Relationship of prosthesis ownership and phantom limb pain: results of a survey in 2383 limb amputees. Pain. 2021 Feb 1;162(2):630-640. doi: 10.1097/j.pain.0000000000002063.
- Background: PubMed 16857400Brodie EE, Whyte A, Niven CA. Analgesia through the looking-glass? A randomized controlled trial investigating the effect of viewing a 'virtual' limb upon phantom limb pain, sensation and movement. Eur J Pain. 2007 May;11(4):428-36. doi: 10.1016/j.ejpain.2006.06.002. Epub 2006 Jul 20.
- Background: PubMed 12551807Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
- Background: PubMed 17053811Flor H, Nikolajsen L, Staehelin Jensen T. Phantom limb pain: a case of maladaptive CNS plasticity? Nat Rev Neurosci. 2006 Nov;7(11):873-81. doi: 10.1038/nrn1991.
- Background: PubMed 30798921Geertzen JHB, van der Schans SM, Jutte PC, Kraeima J, Otten E, Dekker R. Myodesis or myoplasty in trans-femoral amputations. What is the best option? An explorative study. Med Hypotheses. 2019 Mar;124:7-12. doi: 10.1016/j.mehy.2019.01.008. Epub 2019 Jan 16. No abstract available.
- Background: PubMed 12566279Hunter JP, Katz J, Davis KD. The effect of tactile and visual sensory inputs on phantom limb awareness. Brain. 2003 Mar;126(Pt 3):579-89. doi: 10.1093/brain/awg054.
- Background: PubMed 18755249Hunter JP, Katz J, Davis KD. Stability of phantom limb phenomena after upper limb amputation: a longitudinal study. Neuroscience. 2008 Oct 28;156(4):939-49. doi: 10.1016/j.neuroscience.2008.07.053. Epub 2008 Aug 3.
- Background: PubMed 29120308Imam B, Miller WC, Finlayson HC, Eng JJ, Jarus T. Incidence of lower limb amputation in Canada. Can J Public Health. 2017 Nov 9;108(4):e374-e380. doi: 10.17269/cjph.108.6093.
- BackgroundKilteni K, Groten R, Slater M. The Sense of Embodiment in Virtual Reality. Presence: Teleoperators and Virtual Environments. 2012; 21(4): 373-387.
- Background: PubMed 28596267Krutki P, Mrowczynski W, Baczyk M, Lochynski D, Celichowski J. Adaptations of motoneuron properties after weight-lifting training in rats. J Appl Physiol (1985). 2017 Sep 1;123(3):664-673. doi: 10.1152/japplphysiol.00121.2017. Epub 2017 Jun 8.
- Background: PubMed 12161833Marshall HM, Jensen MP, Ehde DM, Campbell KM. Pain site and impairment in individuals with amputation pain. Arch Phys Med Rehabil. 2002 Aug;83(8):1116-9. doi: 10.1053/apmr.2002.33121.
- Background: PubMed 14727702Matjacic Z, Burger H. Dynamic balance training during standing in people with trans-tibial amputation: a pilot study. Prosthet Orthot Int. 2003 Dec;27(3):214-20. doi: 10.1080/03093640308726684.
- Individual participant dataSharing planned: No. In Saskatchewan and Manitoba, the Health Information Protection Act (HIPA) defines how the privacy of participants' personal health information must be maintained so that their privacy and confidentiality will be respected. No information that discloses participant identity will be released or published without the participant's specific consent to the disclosure. However, research records and medical records identifying participants may be inspected in the presence of the principal investigator by the University of Saskatchewan Research Ethics Board for the purpose of monitoring the research. However, no records, which identify a participant by name or initials, will be allowed to leave the principal investigator's office. The results of this study may be presented in a scientific meeting or published, but the participants' identities will not be disclosed.
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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.
Audrey Zucker-Levin, Professor principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted phantom limb motor execution (exercise) in people with Phantom Limb and Motor Activity, run by University of Saskatchewan at 1 site in Canada.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 8 Dec 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phantom limb control as measured by EMG patterning (time frame: 1 year (March 2022 - March 2023)). The study lists 4 primary outcomes in all. 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 NCT05247827, which also lists 23 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 8 Dec 2023.