- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324788
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Transtibial and Transfemoral Amputes.
With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological structure of the muscle, especially in the muscles of the waist, hip and knee and recruitment.
The aim of this study is to investigate the effect of stairing up and down activity on the mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with lower lumbar region pain.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34000
- Yasar Tatar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- to be TTA and TFA
- No complaints of chronic low back pain before amputation
- Using prosthesis for at least 6 months
- Being able to climb up and down stairs
- No history of falls that will cause injury or pain in the past 6 months
- Having good prosthesis comfort
- BMI<28.5
- Who can have cognitive functions to understand Arabic language
Exclusion Criteria:
- To be amputated due to congenital and tumor
- Who can not have cognitive functions to understand Arabic language
- Having orthopedic or neurological disorders that may cause chronic pain or functional impairment in the lumbar region
- Ankylosing spondolitis and rheumatoid arthritis patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Transtibial amputation The patients will be asked to go up and down 9-step stair with the highest speed they can make. |
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
|
Group 2
Transfemoral amputation The patients will be asked to go up and down 9-step stair with the highest speed they can make. |
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the mechanical properties of the muscle-1
Time Frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia
|
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Evaluation of the mechanical properties of the muscle-2
Time Frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
|
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Evaluation of the mechanical properties of the muscle-3
Time Frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
|
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Evaluation of the back pain
Time Frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Pain will be evaluated by using Visual analog scale ranging 0 (no pain)- 10 (worst pain)
|
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Evaluation of the pressure-pain threshold
Time Frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
The pressure-pain threshold (lbs) will be measured in algometer commander (JTECH MEDICAL, MM036_K, 2016)
|
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kelly-Martin R, Doughty L, Garkavi M, Wasserman JB. Reliability of modified adheremeter and digital pressure algometer in measuring normal abdominal tissue and C-section scars. J Bodyw Mov Ther. 2018 Oct;22(4):972-979. doi: 10.1016/j.jbmt.2018.02.017. Epub 2018 Feb 17.
- Devan H, Hendrick P, Ribeiro DC, Hale LA, Carman A. Asymmetrical movements of the lumbopelvic region: is this a potential mechanism for low back pain in people with lower limb amputation? Med Hypotheses. 2014 Jan;82(1):77-85. doi: 10.1016/j.mehy.2013.11.012. Epub 2013 Nov 16.
- Hendershot BD, Bazrgari B, Nussbaum MA. Persons with unilateral lower-limb amputation have altered and asymmetric trunk mechanical and neuromuscular behaviors estimated using multidirectional trunk perturbations. J Biomech. 2013 Jul 26;46(11):1907-12. doi: 10.1016/j.jbiomech.2013.04.018. Epub 2013 May 29.
- Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
- Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
- Michaud SB, Gard SA, Childress DS. A preliminary investigation of pelvic obliquity patterns during gait in persons with transtibial and transfemoral amputation. J Rehabil Res Dev. 2000 Jan-Feb;37(1):1-10.
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
Other Study ID Numbers
- 09.2019.969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Stair up and Down, Amputation
-
Ruhr University of BochumNot yet recruitingOne Week Follow-up Assessment | Six Weeks Follow-up Assessment | Three Months Follow-up AssessmentGermany
-
Liberating Technologies, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAmputation | Prosthesis User | Amputation; Traumatic, Hand | Amputation, CongenitalUnited States
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple Therapeutics...RecruitingAmputation | Amputation; Traumatic, HandUnited States
-
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Medipol UniversityRecruitingEvaluation of Functionality of Amputees According to the Medicare Functional K Classification SystemAmputation | Amputation; Traumatic, Leg, LowerTurkey
-
University of MichiganActive, not recruitingAmputation | Amputation; Traumatic, Leg, LowerUnited States
-
Shirley Ryan AbilityLabUnited States Department of DefenseCompletedAmputation | Amputation; Traumatic, Arm, UpperUnited States
-
Peking University Third HospitalCompletedFollow-up Time, Postoperative Knee Joint Score, Postoperative X-ray, Follow-up Postural Image DataChina
Clinical Trials on Group 1
-
Arkansas Children's Hospital Research InstituteRecruiting
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
-
Ichnos Sciences SAGlenmark Pharmaceuticals S.A.CompletedModerate to Severe Atopic DermatitisUnited States, Canada, Czechia, Germany, Poland
-
Shanghai General Hospital, Shanghai Jiao Tong University...UnknownRetinal Detachment | High Myopia | Macular HolesChina
-
Biruni UniversityCompleted
-
Weill Medical College of Cornell UniversityTerminatedChronic Obstructive Pulmonary Disease | COPDUnited States
-
Biotronik SE & Co. KGBiotronik Japan, Inc.RecruitingImplantable Cardioverter Defibrillator(ICD)Japan
-
Riphah International UniversityCompleted
-
Nantes University HospitalFondation ApicilTerminated
-
University of California, San FranciscoNational Institute on Aging (NIA); Alzheimer's Association; Posit Science Corporation and other collaboratorsCompleted