NCT02934074

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 12, 2016

Last Update Submit

October 12, 2016

Conditions

Keywords

Limb LossGait VariabilityPhantom SensationPhantom PainPeripheral Sensation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Phantom sensation and phantom pain assessment

    Initially evaluation at first minute

  • Sensory test

    Initially evaluation at first minute

Study Arms (1)

Unilateral Lower Limb Loss

Individuals with unilateral lower limb loss will be participants of the group.

Other: No intervention

Interventions

Unilateral Lower Limb Loss

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with traumatic lower limb loss

You may qualify if:

  • Individuals with unilateral lower limb loss Traumatic limb loss Age between 20-55 years Using conventional type socket design Dynamic foot using

You may not qualify if:

  • Have passive joint limitation at extremities Surgery at last 1 year Systemic problems such as neurologic disorders, rheumatoid disorders… Another orthopedic anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amputation, TraumaticPhantom Limb

Condition Hierarchy (Ancestors)

Wounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
20 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,PT

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10