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Completed

NCT Number: NCT07652619

Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

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.

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Key information

Conditions

Transtibial Amputation - Unilateral Transtibial Amputation Transtibial Amputee

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loewenstein Rehabilitation Hospital

Raanana, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor Imagery

Behavioral

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:

  • Introduction to MI- definition, mechanisms of effect, advantages, modalities, and perspectives.
  • Acquaintance with and embodiment of the stump, MI of the prosthesis and MI of the stump-prosthesis interaction (e.g., contact area, pressure).
  • Weight bearing and shifting during sit-to-stand, standing and gait.

Other names: Motor Imagery Practice, Mental Imagery

Primary outcomes

  1. Feasibility: Participants' Recruitement

    Time frame: Within 72 hours post-intervention

    The actual number of participants successfully recruited for each group

  2. Feasiblity: Safety

    Time frame: Within 72 hours post-intervention

    The lack of adverse events or negative effects throughout the intervention.

  3. Feasibility: Compliance

    Time frame: Within 72 hours post-intervention

    The percentage of MI sessions successfully complated by participants

  4. Feasibility: Participants' Feedback

    Time frame: Within 72 hours post-intervention

    Opinions and insights expressed by the participants about the intervention.

  5. Amputee Mobility Predictor

    Time frame: Within 72 hours prior to initial VESSA training

    A 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.

  6. Daily Functioning Ability Test

    Time frame: Within 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.

  7. Timed Up and Go

    Time frame: Once 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.

  8. Ten-meter Walk Test

    Time frame: Once 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 outcomes

  1. Prosthesis Embodiment Scale of Lower Limb Amputees

    Time frame: Within 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).

  2. McGill Pain Questionnaire-Short Form

    Time frame: Within 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).

  3. Kinesthetic Visual Imagery Questionnaire

    Time frame: Within 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.

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Collaborators

  • Loewenstein Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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