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Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

Motor Imagery Prior to or Alongside Initial Prosthetic Gait Training in Acute Transtibial Amputees: A Feasibility Pilot Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07652619
Enrollment
10
Registered
2026-06-17
Start date
2023-01-10
Completion date
2023-10-20
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transtibial Amputation, Transtibial Amputation - Unilateral, Transtibial Amputee

Keywords

transtibial amputation, prosthetic rehabilitation, motor imagery, cognition, gait retraining, rehabilitation

Brief summary

This study included the development of motor imagery (i.e., the cognitive process of mentally reheasing a motor task) protocol for improving prosthetic gait among acute transtibial amputees. Further, the researchers investigated whether praciticng motor imagery before or alongside initial temporary prosthetic training (aka VESSA) would affect measures of functional status, pain, prosthethis embodiement and motor imagery ability.

Detailed description

Background: People undergoing transtibial amputation (TTA) face impairments in gait, balance, confidence, pain, and prosthesis embodiment. Motor imagery (MI) is a cognitive approach for addressing motor and cognitive performance. The current study aimed to (1) explore the feasibility of MI for individuals with acute TTA and (2) investigate the preliminary effects of MI on participants' functional status, gait, pain, prosthesis embodiment and imagery ability. Methods: Ten participants (age range: 46-68 years, eight males) with acute unilateral TTA were randomly allocated into two groups based on delivery timing of MI in relation to temporary prosthesis (Vessa) training: prior to (pre-Vessa) or alongside (w-Vessa), both concurrently with conventional physical therapy. Participants underwent eight individualized MI sessions over two weeks. Data were collected at four timepoints: before and after MI, first independent prosthesis gait, and discharge from the hospital. Outcome measures included intervention feasibility, functional status, pain, prosthesis embodiment and imagery ability.

Interventions

BEHAVIORALMotor Imagery

The motor imagery intervention aimed to: (1) introduce rationale, mechanisms of action, and advantages of MI; (2) facilitate kinesthetic and functional familiarization with the prosthesis; and (3) enhance prosthetic gait, weight-bearing, balance and turning. The protocol followed MI paradigms and methodologies (e.g., combining visual and kinesthetic modalities), including the PETTLEP model that was previously used in amputees. The MI contents addressed movement range of motion, quality, timing, and lower extremity and whole-body intersegmental coordination with motor tasks serving as outcome measures not being explicitly practiced. The following components were included: 1. Introduction to MI- definition, mechanisms of effect, advantages, modalities, and perspectives. 2. Acquaintance with and embodiment of the stump, MI of the prosthesis and MI of the stump-prosthesis interaction (e.g., contact area, pressure). 3. Weight bearing and shifting during sit-to-stand, standing and gait.

Sponsors

Ariel University
Lead SponsorOTHER
Loewenstein Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Masking description

Masking was not possible given the study design.

Intervention model description

Participants were allocated into one of two groups: 'pre-Vessa' ('pVessa') or 'with-Vessa' ('wVessa'). Group allocation was based on a cutoff of 14 days (estimated by medical staff) remaining until initial Vessa training. Participants with more than 14 days left were alternately allocated to either group, whereas participants with less than 14 days were allocated to the wVessa group

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Unilateral transtibial amputation * No experience with VESSA training

Exclusion criteria

* Vestibular and/or cerebellar disorders * Cognitive impairments (e.g., mental retardation) * Hearing and/or visual impairment * Bilateral amputation * Acute medical exacerbation in the past two weeks

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: Participants' RecruitementWithin 72 hours post-interventionThe actual number of participants successfully recruited for each group
Feasiblity: SafetyWithin 72 hours post-interventionThe lack of adverse events or negative effects throughout the intervention.
Feasibility: ComplianceWithin 72 hours post-interventionThe percentage of MI sessions successfully complated by participants
Feasibility: Participants' FeedbackWithin 72 hours post-interventionOpinions and insights expressed by the participants about the intervention.
Amputee Mobility PredictorWithin 72 hours prior to initial VESSA trainingA functional assessment of mobility level for determining the appropriate prosthetic prescription. The test consists of 21 daily living functional motor tasks (e.g., turning, sitting down, and walking over an obstacle). Scores are "0" ('inability to perform the task'), "1" ('minimal level of achievement or that some assistance was required in completing the task'), or "2" ('complete independence or mastery of the task'). A higher score indicates a greater level of prosthesis function.
Daily Functioning Ability TestWithin 72 hours pre-intervention, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)An 18-item test for assessing patients' daily functioning inside and outside the hospital ward. Each item is rated on a 7-point scale, with higher scores representing less assistance needed by the patient. Scoring categories are: fully independent (109-126), independent with assistance devices (91-108), requiring supervision (73-90), requiring assistance (37-72), and fully dependent (nursing care; 18-36). Higher scores mean a better outcome.
Timed Up and GoOnce first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)A functional test for quantifying functional mobility. The participants are asked to rise from a chair, walk 3 meters, turn around an obstacle, and return to take a seat as quickly and safely as possible. The average time (in seconds) of two trials was recorded using a stopwatch. Lower scores mean a better outcome.
Ten-meter Walk TestOnce first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours)A functional test for assessing early gait after amputation. The time (in seconds) for completing a ten-meter forward walk was recorded.

Secondary

MeasureTime frameDescription
Prosthesis Embodiment Scale of Lower Limb AmputeesWithin 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).A 10-item questionnaire for assessing perceptual correlates of successful body-prosthesis interaction (i.e., acceptance). Scores for each item are on a 7-point Likert scale ranging from "-3" ('strongly disagree') to "+3" ('strongly agree'). Higher scores mean better outcome (i.e., higher prosthesis embodiment).
McGill Pain Questionnaire-Short FormWithin 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).A 17-item self-administered questionnaire for assessing pain, including post amputation pain. The questionnaire includes three sections: pain visual analog scale (VAS; 0-10 scale), pain intensity index (PPI; 0-5 scale), and total McGill score (0-45 scale). Higher scores mean worse outcome (i.e., higher levels of pain).
Kinesthetic Visual Imagery QuestionnaireWithin 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).A 5-item questionnaire for assessing MI clarity (visual subscale) and intensity (kinesthetic subscale) of motor tasks, including the amputated ('affected') and intact ('unaffected') . Scores range between "1" ('no image at all') and "5" ('image as clear as seeing'). Higher scores mean a better outcome.

Countries

Israel

Contacts

STUDY_DIRECTORAmir Haim, MD

Loewenstein Rehabilitation Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026