Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

NCT07652619 | Completed DMC

• 1 other identifier: 0017-22-LOE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputation - Unilateral; Transtibial Amputation; Transtibial Amputee

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Feasibility: Participants' Recruitement

  The actual number of participants successfully recruited for each group

  Within 72 hours post-intervention

• Feasiblity: Safety

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

  Within 72 hours post-intervention

• Feasibility: Compliance

  The percentage of MI sessions successfully complated by participants

  Within 72 hours post-intervention

• Feasibility: Participants' Feedback

  Opinions and insights expressed by the participants about the intervention.

  Within 72 hours post-intervention

• Amputee Mobility Predictor

  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.

  Within 72 hours prior to initial VESSA training

• Daily Functioning Ability Test

  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.

  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)

• Timed Up and Go

  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.

  Once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)

• Ten-meter Walk Test

  A functional test for assessing early gait after amputation. The time (in seconds) for completing a ten-meter forward walk was recorded.

  Once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours)

Secondary Outcomes (3)

• Prosthesis Embodiment Scale of Lower Limb Amputees

  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).

• McGill Pain Questionnaire-Short Form

  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).

• Kinesthetic Visual Imagery Questionnaire

  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).

Study Arms (2)

Pre VESSA

EXPERIMENTAL

Participants attended the motor imagery training prior to beginning actual temporary prosthetic (VESSA) training

Behavioral: Motor Imagery

With VESSA

EXPERIMENTAL

Participants attended the motor imagery training alongside actual temporary prosthetic (VESSA) training

Behavioral: Motor Imagery

Interventions

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: 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.

Also known as: Motor Imagery Practice, Mental Imagery

Pre VESSA; With VESSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transtibial amputation
• No experience with VESSA training

You may not qualify if:

• 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

Sponsors & Collaborators

• Ariel University: lead
• Loewenstein Hospital: collaborator

Study Sites (1)

Loewenstein Rehabilitation Hospital

Raanana, Israel

Location

Related Publications (19)

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• Samuelsen BT, Andrews KL, Houdek MT, Terry M, Shives TC, Sim FH. The Impact of the Immediate Postoperative Prosthesis on Patient Mobility and Quality of Life after Transtibial Amputation. Am J Phys Med Rehabil. 2017 Feb;96(2):116-119. doi: 10.1097/PHM.0000000000000553.

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Study Officials

• Amir Haim, MD

  Loewenstein Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not possible given the study design.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 17, 2026
• Study Start: January 10, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available once the manuscript is published and for approximately 2 years.

Locations

IL (1)