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Clinical Trials/NCT04324788
NCT04324788
Completed
N/A

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

Marmara University1 site in 1 country28 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stair up and Down, Amputation
Sponsor
Marmara University
Enrollment
28
Locations
1
Primary Endpoint
Evaluation of the mechanical properties of the muscle-1
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
December 20, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

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)

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

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)

Study Sites (1)

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