The Effects of Targeted Phantom Motor Execution on Phantom Limb Control

NCT05247827 | Completed

• 1 other identifier: Bio 2855
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Phantom Limb; Motor Activity; Amputation Stump; Amputation

Keywords

Prosthetic embodiment; Surgical closure; Phantom limb control; Physical function

Outcome Measures

Primary Outcomes (4)

• Phantom limb control as measured by EMG patterning

  The ability to intentionally move or control movements of the phantom limb

  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

  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

  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.

  1 year (March 2022 - March 2023)

Secondary Outcomes (4)

• Amplitude of electromyography (EMG) of the agonist and antagonist muscles's activity

  1 year (March 2022 - March 2023)

• Frequency of electromyography (EMG) of the agonist and antagonist muscles's activity

  1 year (March 2022 - March 2023)

• Index of electromyography (EMG) co-activation of the agonist and antagonist muscles

  1 year (March 2022 - March 2023)

• Foot plantar load (N)

  1 year (March 2022 - March 2023)

Study Arms (2)

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.

Other: Targeted phantom limb motor execution (exercise)

Interventions

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).

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Manitoba: collaborator

Study Sites (1)

Winnipeg Prosthetics and Orthotics (WinPO) Clinic

Winnipeg, Manitoba, R2H 0T6, Canada

Location

Related Publications (23)

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  BACKGROUND

• 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.

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  PMID: 12161833 BACKGROUND

• Matjacic 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.

  PMID: 14727702 BACKGROUND

• Montoya 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.

  PMID: 9272791 BACKGROUND

• Moseley 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.

  PMID: 19858475 BACKGROUND

• Ortiz-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.

  PMID: 27916234 BACKGROUND

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  PMID: 12514453 BACKGROUND

• Schafer ZA, Perry JL, Vanicek N. A personalised exercise programme for individuals with lower limb amputation reduces falls and improves gait biomechanics: A block randomised controlled trial. Gait Posture. 2018 Jun;63:282-289. doi: 10.1016/j.gaitpost.2018.04.030. Epub 2018 Apr 30.

  PMID: 29804023 BACKGROUND

• Schoenfeld BJ. The mechanisms of muscle hypertrophy and their application to resistance training. J Strength Cond Res. 2010 Oct;24(10):2857-72. doi: 10.1519/JSC.0b013e3181e840f3.

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  PMID: 23462830 BACKGROUND

• Srinivasan SS, Gutierrez-Arango S, Teng AC, Israel E, Song H, Bailey ZK, Carty MJ, Freed LE, Herr HM. Neural interfacing architecture enables enhanced motor control and residual limb functionality postamputation. Proc Natl Acad Sci U S A. 2021 Mar 2;118(9):e2019555118. doi: 10.1073/pnas.2019555118.

  PMID: 33593940 BACKGROUND

• Stankevicius A, Wallwork SB, Summers SJ, Hordacre B, Stanton TR. Prevalence and incidence of phantom limb pain, phantom limb sensations and telescoping in amputees: A systematic rapid review. Eur J Pain. 2021 Jan;25(1):23-38. doi: 10.1002/ejp.1657. Epub 2020 Sep 28.

  PMID: 32885523 BACKGROUND

• Trevelyan EG, Turner WA, Robinson N. Perceptions of phantom limb pain in lower limb amputees and its effect on quality of life: a qualitative study. Br J Pain. 2016 May;10(2):70-7. doi: 10.1177/2049463715590884. Epub 2015 Jun 23.

  PMID: 27551416 BACKGROUND

• Yaghi K, Yaghi Y, McDonald AA, Yadegarfar G, Cecil E, Seidl J, Dubois E, Rawaf S, Majeed A. Diabetes or war? Incidence of and indications for limb amputation in Lebanon, 2007. East Mediterr Health J. 2012 Dec;18(12):1178-86.

  PMID: 23301391 BACKGROUND

MeSH Terms

Conditions

Phantom Limb; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Audrey Zucker-Levin, Professor

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 21, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)