Comparison of Different Amputation Levels

Completed

• Conditions: Plantar Pressure Distrubution; Balance; Amputee
• Interventions: Other: Bipedal with open eyes; Other: Bipedal with closed eyes; Other: Bipedal with open eyes and with platform; Other: Bipedal with closed eyes and with platform

• Registration Number: NCT04330274
• Lead Sponsor: Marmara University

Brief Summary

Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-10-01
• Primary Completion: 2020-02-10
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Being unilateral transfemoral or transtibial amputee
• Have the level of perception to understand and apply the commands given
• Having sedantary life styles

Exclusion Criteria

• Having a neurological or orthopedic disorder that may affect standing posture and balance
• The presence of pain that can affect standing posture and balance
• Visual impairment that impairs the gait pattern and balance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Bipedal with closed eyes and with platform	Unilateral transfemoral amputee
Group 1	Bipedal with open eyes	Unilateral transtibial amputee
Group 1	Bipedal with closed eyes	Unilateral transtibial amputee
Group 2	Bipedal with open eyes	Unilateral transfemoral amputee
Group 1	Bipedal with closed eyes and with platform	Unilateral transtibial amputee
Group 2	Bipedal with closed eyes	Unilateral transfemoral amputee
Group 2	Bipedal with open eyes and with platform	Unilateral transfemoral amputee
Group 1	Bipedal with open eyes and with platform	Unilateral transtibial amputee

Primary Outcome Measures

Name	Time	Method
Measurement of plantar pressure distrubution	Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.	Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel
Determination of center of pressure	Change from baseline center of pressure at second 10, second 20 and second 30.	Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey