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

Completed

• Conditions: Stair up and Down, Amputation; Amputation,Stair up and Down
• Interventions: Other: Group 1; Other: Group 2

• Registration Number: NCT04324788
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Primary Completion: 2020-04-15
• Study Completion: 2020-12-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	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 2	Group 2	Transfemoral amputation The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Primary Outcome Measures

Name	Time	Method
Evaluation of the mechanical properties of the muscle-1	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	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	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	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	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)

Trial Locations

Locations (1)

Yasar Tatar; 🇹🇷 Istanbul, Turkey