NCT05247827

The Effects of Targeted Phantom Motor Execution on Phantom Limb Control

Completed NA Last updated 8 December 2023

What this trial tests

NA trial testing Targeted phantom limb motor execution (exercise) in Phantom Limb in 30 participants. Completed in 1 May 2023.

Timeline

1 June 2022

Primary endpoint
1 March 2023

1 May 2023

Quick facts

Lead sponsor	University of Saskatchewan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 June 2022
Primary completion	1 March 2023
Estimated completion	1 May 2023
Sites	1 location across Canada

Drugs / interventions tested

• Targeted phantom limb motor execution (exercise)

Conditions studied

• Phantom Limb — all drugs for Phantom Limb →
• Motor Activity — all drugs for Motor Activity →
• Amputation Stump — all drugs for Amputation Stump →
• Amputation — all drugs for Amputation →

Sponsor

University of Saskatchewan

Who can join

18 and older, any sex, with Phantom Limb or Motor Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.