Clinical Trial: Relationship Between Gait Variability and Sensation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: Investigating the Relationship Between Gait Variability and Related Factors in Individuals With Lower Limb Loss

Brief 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

Detailed Summary:

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.


Sponsor: Hacettepe University

Current Primary Outcome: Step length variability assesment while walking. [ Time Frame: Initially evaluation at first minute ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Phantom sensation and phantom pain assessment [ Time Frame: Initially evaluation at first minute ]
    Phantom sensation and phantom pain will be asked as existence or not.
  • Sensory test [ Time Frame: Initially evaluation at first minute ]
    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.


Original Secondary Outcome: Same as current

Information By: Hacettepe University

Dates:
Date Received: October 12, 2016
Date Started: October 2016
Date Completion: November 2016
Last Updated: October 12, 2016
Last Verified: October 2016