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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Saskatchewan
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Time score for four-square step test (s)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control Group
Participants will receive usual and customary post-amputation treatment
Exercise Group
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.
Intervention: Targeted phantom limb motor execution (exercise) (Other)
Outcomes
Primary Outcomes
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.
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
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
Secondary Outcomes
- Foot plantar load (N)(1 year (March 2022 - March 2023))
- 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))
Investigators
Audrey Zucker-Levin
Professor
University of Saskatchewan