- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652619
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Raanana, Israel
- Loewenstein Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre VESSA
Participants attended the motor imagery training prior to beginning actual temporary prosthetic (VESSA) training
|
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:
Other Names:
|
|
Experimental: With VESSA
Participants attended the motor imagery training alongside actual temporary prosthetic (VESSA) training
|
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:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Participants' Recruitement
Time Frame: Within 72 hours post-intervention
|
The actual number of participants successfully recruited for each group
|
Within 72 hours post-intervention
|
|
Feasiblity: Safety
Time Frame: Within 72 hours post-intervention
|
The lack of adverse events or negative effects throughout the intervention.
|
Within 72 hours post-intervention
|
|
Feasibility: Compliance
Time Frame: Within 72 hours post-intervention
|
The percentage of MI sessions successfully complated by participants
|
Within 72 hours post-intervention
|
|
Feasibility: Participants' Feedback
Time Frame: Within 72 hours post-intervention
|
Opinions and insights expressed by the participants about the intervention.
|
Within 72 hours post-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.
|
Within 72 hours prior to initial VESSA training
|
|
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.
|
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
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.
|
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
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.
|
Once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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).
|
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).
|
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).
|
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.
|
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).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Amir Haim, MD, Loewenstein Rehabilitation Hospital
Publications and helpful links
General Publications
- Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Malouin 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.
- MacKenzie 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.
- Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
- Abraham 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.
- Lotze 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.
- Essien SK, Kopriva D, Linassi AG, Zucker-Levin A. Trends of limb amputation considering type, level, sex and age in Saskatchewan, Canada 2006-2019: an in-depth assessment. Arch Public Health. 2022 Jan 4;80(1):10. doi: 10.1186/s13690-021-00759-1.
- 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.
- Saruco 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.
- Ladda 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.
- Jeannerod M. Mental imagery in the motor context. Neuropsychologia. 1995 Nov;33(11):1419-32. doi: 10.1016/0028-3932(95)00073-c.
- Bekrater-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.
- Isakov 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.
- Isakov 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.
- Barr 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.
- 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.
- Zidarov 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.
- Sarroca 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.
- Kalbaugh CA, Strassle PD, Paul NJ, McGinigle KL, Kibbe MR, Marston WA. Trends in Surgical Indications for Major Lower Limb Amputation in the USA from 2000 to 2016. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):88-96. doi: 10.1016/j.ejvs.2020.03.018. Epub 2020 Apr 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0017-22-LOE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transtibial Amputation
-
MuscleMetrix, LLCRecruitingTranstibial Amputation | Transtibial AmputeeUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Miami; Walter Reed National Military Medical Center; Uniformed... and other collaboratorsUnknownTranstibial Amputation | Transfemoral AmputationUnited States
-
VA Office of Research and DevelopmentRecruitingTranstibial Amputation | Transfemoral AmputationUnited States
-
US Department of Veterans AffairsUniversity of MichiganCompletedTranstibial AmputationUnited States
-
VA Office of Research and DevelopmentCompletedTranstibial AmputationUnited States
-
Southern California Institute for Research and...California State University, Long Beach; California State University, Dominguez...UnknownTranstibial AmputationUnited States
-
University of WashingtonCompleted
-
University of OklahomaTerminated
-
Massachusetts Institute of TechnologyEnrolling by invitationTranstibial Amputation - UnilateralUnited States
-
Union de Gestion des Etablissements des Caisses...Otto Bock France SNC; Hôpital d'Instruction des armées Percy; Institution Nationale... and other collaboratorsRecruitingTranstibial Amputation | Lower Limb Amputation Below KneeFrance
Clinical Trials on Motor Imagery
-
Abant Izzet Baysal UniversityNot yet recruitingCerebral Palsy (CP) | Spasticity | Motor LearningTurkey
-
Ege UniversityThe Scientific and Technological Research Council of TurkeyCompletedMotor Imagery Training | Virtual Reality | Resistance TrainingTurkey (Türkiye)
-
Abant Izzet Baysal UniversityRecruitingCerebral Palsy, SpasticTurkey
-
KTO Karatay UniversityRecruitingPregnancy-related Lumbopelvic PainTurkey (Türkiye)
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Universidad Autonoma de MadridCompletedAnalgesia | ExerciseSpain
-
Dr. Mehak NaeemUniversity of Health Sciences LahoreRecruiting
-
Seoul National University Bundang HospitalTerminatedStroke | HemiplegiaKorea, Republic of
-
Green International UniversityCompletedComplex Regional Pain Syndrome (CRPS) | Shoulder Hand SyndromePakistan
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown