The Effects of Targeted Phantom Motor Execution on Phantom Limb Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Phantom Limb, Motor Activity, Amputation Stump, Amputation

Intervention / Treatment
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* Other: Targeted phantom limb motor execution (exercise)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants will receive usual and customary post-amputation treatment | |
| Experimental: Exercise Group<br>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)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 1 year (March 2022 - March 2023) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthetic embodiment, Surgical closure, Phantom limb control, Physical function