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Relationship Between Gait Variability and Sensation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02934074
Enrollment
20
Registered
2016-10-14
Start date
2016-10-31
Completion date
2016-11-30
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Traumatic

Keywords

Limb Loss, Gait Variability, Phantom Sensation, Phantom Pain, Peripheral Sensation

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 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.

Interventions

OTHERNo intervention

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Step length variability assesment while walking.Initially evaluation at first minuteGait 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.

Secondary

MeasureTime frameDescription
Phantom sensation and phantom pain assessmentInitially evaluation at first minutePhantom sensation and phantom pain will be asked as existence or not.
Sensory testInitially evaluation at first minuteSensorial 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026