Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss

Amputation Clinical Trial

Official title:

Comparison of Gait Characteristics in Individuals With Trans Femaoral and Trans Tibial Limb Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02988310
• Other study ID #: G10
• Status: Not yet recruiting
• Phase: N/A
• First received: December 7, 2016
• Last updated: December 8, 2016
• Start date: December 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.

Description:

Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this study.

Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index, gait speed) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 4nd and 6th minutes at walk.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Individuals with unilateral above knee lower limb loss and below knee limb loss

• Age between 20-55 years

• Using conventional type socket design Dynamic foot using

Exclusion Criteria:

• Have passive joint limitation at extremities

• Surgery at last 1 year

• Systemic problems such as neurological disorders, rheumatoid disorders

• Another orthopedic anomalies

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step length assesment while walking.		Initially evaluation at first minute	Yes
Secondary	Ambulation index assessment while walking.		Initially evaluation at first minute	Yes