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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02934074
Other study ID # GO 16/344
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 12, 2016
Last updated October 12, 2016
Start date October 2016
Est. completion date November 2016

Study information

Verified date October 2016
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Twenty individuals who were referred to receive physiotherapy 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, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments


Description:

Twenty participants with lower limb loss who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, will be the subjects of this study.

Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) 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 2nd and 4th minutes at walk. Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

Individuals with unilateral lower limb loss Traumatic 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 neurologic disorders, rheumatoid disorders… Another orthopedic anomalies

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


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 variability assesment while walking. Gait parameters (step length, variation of step length) will be evaluated 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 2nd and 4th minutes at walk. Initially evaluation at first minute Yes
Secondary Phantom sensation and phantom pain assessment Phantom sensation and phantom pain will be asked as existence or not. Initially evaluation at first minute Yes
Secondary Sensory test Sensorial loss will be evaluated with Semmes Weinstein Monofilaments (SWME) which is a noninvasive, inexpensive, rapid, and easy-to-apply test and often used in clinical routine assessment. The monofilaments will be applied to the stump along to the incision area and grafted skin area until the monofilaments bended for about one second. Participants will be instructed to say "yes" once they feel the monofilament on their skin. Each test will be repeated for 7 times whether the sensation loss was existed or not. Five true answers from 7 repeat will be accepted as normal feeling. Monofilament tests will beggin at 4.56 as known as protective sensation. Initially evaluation at first minute Yes
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