NCT04324788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

March 24, 2020

Last Update Submit

September 27, 2021

Conditions

Stair up and Down, AmputationAmputation,Stair up and Down

Outcome Measures

Primary Outcomes (5)

  • Evaluation of the mechanical properties of the muscle-1

    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

    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

    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

    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

    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

Study Arms (2)

Group 1

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

Other: Group 1

Group 2

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

Other: Group 2

Interventions

Group 1OTHER

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

Group 1
Group 2OTHER

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

Group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailswith unilateral transtibial/transfemoral amputation
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Unilateral transfemoral and transtibial amputate patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasar Tatar

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 24296234BACKGROUND

  • 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.

    PMID: 23726183BACKGROUND

  • 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.

    PMID: 28066528BACKGROUND

  • 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.

    PMID: 30254233BACKGROUND

  • 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.

    PMID: 10847567BACKGROUND

  • 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.

    PMID: 30368344BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

February 1, 2020

Primary Completion

April 15, 2020

Study Completion

December 20, 2020

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)