Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.

NCT ID: NCT04324788

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Stair up and Down, Amputation Amputation,Stair up and Down

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Transtibial amputation

The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Group 1

Intervention Type OTHER

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.

Group 2

Intervention Type OTHER

The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Interventions

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Group 1

The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Intervention Type OTHER

Group 2

The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yasar Tatar

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24296234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23726183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28066528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30254233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10847567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30368344 (View on PubMed)

Other Identifiers

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09.2019.969

Identifier Type: -

Identifier Source: org_study_id

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