Transtibial Amputation - UnilateralNCT07652619
Motor Imagery for Prosthetic Gait Training in Transtibial Amputees
A study testing Motor Imagery in people with Transtibial Amputation - Unilateral and Transtibial Amputation, run by Ariel University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transtibial Amputation - Unilateral, Transtibial Amputation, Transtibial Amputee
- What is being tested?
- Motor Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jan 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputation
- No experience with VESSA training
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Imagery Prior to or Alongside Initial Prosthetic Gait Training in Acute Transtibial Amputees: A Feasibility Pilot Study
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.
Read the 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.
- Being tested
- Motor Imagery
- Keywords
- transtibial amputation, prosthetic rehabilitation, motor imagery, cognition, gait retraining, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ImageryBehavioural
Also called Motor Imagery Practice, Mental 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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pre VESSA | Experimental | Participants attended the motor imagery training prior to beginning actual temporary prosthetic (VESSA) training Receives: Behavioral: Motor Imagery |
| With VESSA | Experimental | Participants attended the motor imagery training alongside actual temporary prosthetic (VESSA) training Receives: Behavioral: Motor Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Participants' Recruitement
The actual number of participants successfully recruited for each group
Measured: Within 72 hours post-intervention
Feasiblity: Safety
The lack of adverse events or negative effects throughout the intervention.
Measured: Within 72 hours post-intervention
Feasibility: Compliance
The percentage of MI sessions successfully complated by participants
Measured: Within 72 hours post-intervention
Feasibility: Participants' Feedback
Opinions and insights expressed by the participants about the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start10 Jan 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Transtibial Amputation - UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Loewenstein Hospital
- Responsible party
- Sponsor
- Investigators
- Amir Haim, MD, Study director, Loewenstein Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652619
- Sponsor's protocol ID
- 0017-22-LOE
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data (without identifiers) will be shared upon request submitted by email to the researchers.
Publications
Bekrater-Bodmann R. Mind over matter: Perceived phantom/prosthesis co-location contributes to prosthesis embodiment in lower limb amputees. Conscious Cogn. 2022 Feb;98:103268. doi: 10.1016/j.concog.2021.103268. Epub 2022 Jan 6.
PubMed 34999318Abraham A, Hart A, Andrade I, Hackney ME. Dynamic Neuro-Cognitive Imagery Improves Mental Imagery Ability, Disease Severity, and Motor and Cognitive Functions in People with Parkinson's Disease. Neural Plast. 2018 Mar 14;2018:6168507. doi: 10.1155/2018/6168507. eCollection 2018.
PubMed 29725348Malouin F, Richards CL, Jackson PL, Lafleur MF, Durand A, Doyon J. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007 Mar;31(1):20-9. doi: 10.1097/01.npt.0000260567.24122.64.
PubMed 17419886Saruco E, Guillot A, Saimpont A, Di Rienzo F, Durand A, Mercier C, Malouin F, Jackson P. Motor imagery ability of patients with lower-limb amputation: exploring the course of rehabilitation effects. Eur J Phys Rehabil Med. 2019 Oct;55(5):634-645. doi: 10.23736/S1973-9087.17.04776-1. Epub 2017 Nov 16.
PubMed 29144105Ladda AM, Lebon F, Lotze M. Using motor imagery practice for improving motor performance - A review. Brain Cogn. 2021 Jun;150:105705. doi: 10.1016/j.bandc.2021.105705. Epub 2021 Feb 27.
PubMed 33652364Jeannerod M. Mental imagery in the motor context. Neuropsychologia. 1995 Nov;33(11):1419-32. doi: 10.1016/0028-3932(95)00073-c.
PubMed 8584178Lotze M, Halsband U. Motor imagery. J Physiol Paris. 2006 Jun;99(4-6):386-95. doi: 10.1016/j.jphysparis.2006.03.012. Epub 2006 May 22.
PubMed 16716573Bekrater-Bodmann R. Factors Associated With Prosthesis Embodiment and Its Importance for Prosthetic Satisfaction in Lower Limb Amputees. Front Neurorobot. 2021 Jan 15;14:604376. doi: 10.3389/fnbot.2020.604376. eCollection 2020.
PubMed 33519413Isakov E, Burger H, Krajnik J, Gregoric M, Marincek C. Influence of speed on gait parameters and on symmetry in trans-tibial amputees. Prosthet Orthot Int. 1996 Dec;20(3):153-8. doi: 10.3109/03093649609164437.
PubMed 8985994Isakov E, Keren O, Benjuya N. Trans-tibial amputee gait: time-distance parameters and EMG activity. Prosthet Orthot Int. 2000 Dec;24(3):216-20. doi: 10.1080/03093640008726550.
PubMed 11195356Barr S, Howe TE. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD005260. doi: 10.1002/14651858.CD005260.pub4.
PubMed 30350430Samuelsen 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.
PubMed 27386805Zidarov D, Swaine B, Gauthier-Gagnon C. Quality of life of persons with lower-limb amputation during rehabilitation and at 3-month follow-up. Arch Phys Med Rehabil. 2009 Apr;90(4):634-45. doi: 10.1016/j.apmr.2008.11.003.
PubMed 19345780Sarroca N, Valero J, Deus J, Casanova J, Luesma MJ, Lahoz M. Quality of life, body image and self-esteem in patients with unilateral transtibial amputations. Sci Rep. 2021 Jun 15;11(1):12559. doi: 10.1038/s41598-021-91954-1.
PubMed 34131211MacKenzie EJ, Jones AS, Bosse MJ, Castillo RC, Pollak AN, Webb LX, Swiontkowski MF, Kellam JF, Smith DG, Sanders RW, Jones AL, Starr AJ, McAndrew MP, Patterson BM, Burgess AR. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92. doi: 10.2106/JBJS.F.01350.
PubMed 17671005
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery Prior to or Alongside Initial Prosthetic Gait Training in Acute Transtibial Amputees: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT07652619
- Acronym / sponsor ID
- 0017-22-LOE
- Keywords
- transtibial amputation, prosthetic rehabilitation, motor imagery, cognition, gait retraining, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Loewenstein Hospital
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pre VESSA | Experimental | Behavioral: Motor ImageryParticipants attended the motor imagery training prior to beginning actual temporary prosthetic (VESSA) training |
| With VESSA | Experimental | Behavioral: Motor ImageryParticipants attended the motor imagery training alongside actual temporary prosthetic (VESSA) training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral transtibial amputation
- No experience with VESSA training
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor ImageryAlso: Motor Imagery Practice, Mental ImageryThe 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. | Behavioural | Pre VESSA, With VESSA |
Primary outcome
Feasibility: Participants' Recruitement
Time frame: Within 72 hours post-intervention
The actual number of participants successfully recruited for each group
Feasiblity: Safety
Time frame: Within 72 hours post-intervention
The lack of adverse events or negative effects throughout the intervention.
Feasibility: Compliance
Time frame: Within 72 hours post-intervention
The percentage of MI sessions successfully complated by participants
Feasibility: Participants' Feedback
Time frame: Within 72 hours post-intervention
Opinions and insights expressed by the participants about the intervention.
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.
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.
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.
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.
3 secondary outcomes
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 34999318Bekrater-Bodmann R. Mind over matter: Perceived phantom/prosthesis co-location contributes to prosthesis embodiment in lower limb amputees. Conscious Cogn. 2022 Feb;98:103268. doi: 10.1016/j.concog.2021.103268. Epub 2022 Jan 6.
- Background: PubMed 29725348Abraham A, Hart A, Andrade I, Hackney ME. Dynamic Neuro-Cognitive Imagery Improves Mental Imagery Ability, Disease Severity, and Motor and Cognitive Functions in People with Parkinson's Disease. Neural Plast. 2018 Mar 14;2018:6168507. doi: 10.1155/2018/6168507. eCollection 2018.
- Background: PubMed 17419886Malouin F, Richards CL, Jackson PL, Lafleur MF, Durand A, Doyon J. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007 Mar;31(1):20-9. doi: 10.1097/01.npt.0000260567.24122.64.
- Background: PubMed 29144105Saruco E, Guillot A, Saimpont A, Di Rienzo F, Durand A, Mercier C, Malouin F, Jackson P. Motor imagery ability of patients with lower-limb amputation: exploring the course of rehabilitation effects. Eur J Phys Rehabil Med. 2019 Oct;55(5):634-645. doi: 10.23736/S1973-9087.17.04776-1. Epub 2017 Nov 16.
- Background: PubMed 33652364Ladda AM, Lebon F, Lotze M. Using motor imagery practice for improving motor performance - A review. Brain Cogn. 2021 Jun;150:105705. doi: 10.1016/j.bandc.2021.105705. Epub 2021 Feb 27.
- Background: PubMed 8584178Jeannerod M. Mental imagery in the motor context. Neuropsychologia. 1995 Nov;33(11):1419-32. doi: 10.1016/0028-3932(95)00073-c.
- Background: PubMed 16716573Lotze M, Halsband U. Motor imagery. J Physiol Paris. 2006 Jun;99(4-6):386-95. doi: 10.1016/j.jphysparis.2006.03.012. Epub 2006 May 22.
- Background: PubMed 33519413Bekrater-Bodmann R. Factors Associated With Prosthesis Embodiment and Its Importance for Prosthetic Satisfaction in Lower Limb Amputees. Front Neurorobot. 2021 Jan 15;14:604376. doi: 10.3389/fnbot.2020.604376. eCollection 2020.
- Background: PubMed 8985994Isakov E, Burger H, Krajnik J, Gregoric M, Marincek C. Influence of speed on gait parameters and on symmetry in trans-tibial amputees. Prosthet Orthot Int. 1996 Dec;20(3):153-8. doi: 10.3109/03093649609164437.
- Background: PubMed 11195356Isakov E, Keren O, Benjuya N. Trans-tibial amputee gait: time-distance parameters and EMG activity. Prosthet Orthot Int. 2000 Dec;24(3):216-20. doi: 10.1080/03093640008726550.
- Background: PubMed 30350430Barr S, Howe TE. Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD005260. doi: 10.1002/14651858.CD005260.pub4.
- Background: PubMed 27386805Samuelsen 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.
- Individual participant dataSharing planned: Yes. Collected data (without identifiers) will be shared upon request submitted by email to the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Haim, MD study director
Loewenstein Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery in people with Transtibial Amputation - Unilateral and Transtibial Amputation, run by Ariel University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Participants' Recruitement (time frame: Within 72 hours post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07652619, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.