Clinical trial NCT04324788: Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.
Official title: Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Transtibial and Transfemoral Amputes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stair up and Down, Amputation
Amputation,Stair up and Down
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unilateral transfemoral and transtibial amputate patients

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the mechanical properties of the muscle-1
timeFrame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
measure: Evaluation of the mechanical properties of the muscle-2
timeFrame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
measure: Evaluation of the mechanical properties of the muscle-3
timeFrame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
measure: Evaluation of the back pain
timeFrame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
measure: Evaluation of the pressure-pain threshold
timeFrame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yasar Tatar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.