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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Raanana、以色列
- Loewenstein Rehabilitation Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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:
其他名称:
|
|
实验性的: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:
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility: Participants' Recruitement
大体时间:Within 72 hours post-intervention
|
The actual number of participants successfully recruited for each group
|
Within 72 hours post-intervention
|
|
Feasiblity: Safety
大体时间:Within 72 hours post-intervention
|
The lack of adverse events or negative effects throughout the intervention.
|
Within 72 hours post-intervention
|
|
Feasibility: Compliance
大体时间:Within 72 hours post-intervention
|
The percentage of MI sessions successfully complated by participants
|
Within 72 hours post-intervention
|
|
Feasibility: Participants' Feedback
大体时间:Within 72 hours post-intervention
|
Opinions and insights expressed by the participants about the intervention.
|
Within 72 hours post-intervention
|
|
Amputee Mobility Predictor
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prosthesis Embodiment Scale of Lower Limb Amputees
大体时间: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
大体时间: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
大体时间: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).
|
合作者和调查者
调查人员
- 研究主任:Amir Haim, MD、Loewenstein Rehabilitation Hospital
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.