NCT02988310

Brief 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.

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
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

1 month

First QC Date

December 7, 2016

Last Update Submit

December 8, 2016

Conditions

Amputation

Keywords

Limb LossGait Characteristics

Outcome Measures

Primary Outcomes (1)

  • Step length assesment while walking.

    Initially evaluation at first minute

Secondary Outcomes (1)

  • Ambulation index assessment while walking.

    Initially evaluation at first minute

Study Arms (3)

Individuals with below knee limb loss

Individuals with below knee limb loss will be participants of the group.

Other: No intervention

Individuals with above knee limb loss

Individuals with above knee limb loss will be participants of the group.

Other: No intervention

Healthy individuals

Healthy individuals will be participants of the group.

Other: No intervention

Interventions

No interventionOTHER
Healthy individualsIndividuals with above knee limb lossIndividuals with below knee limb loss

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with unilateral below or above knee limb loss

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD,PT

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 9, 2016

Record last verified: 2016-12