NCT05435326

Brief Summary

Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.

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
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 23, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

amputationstump lengthmuscle strengthbalanceproprioception

Outcome Measures

Primary Outcomes (1)

  • The isokinetic muscle strength of the hip extensors and flexors

    The isokinetic muscle strength of the hip extensors and flexors will be measured with the computer -assisted isokinetic system (CYBEX). The tests were performed at the angular velocities of 60° and 120°/s, while measuring flexion and extension of the amputated side.

    through study completion, an average of one month

Secondary Outcomes (2)

  • The Berg Balance Scale (BBS)

    through study completion, an average of one month

  • Proprioception assessment

    through study completion, an average of one month

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18-65 who underwent traumatic amputation at least 6 months ago will participate in the study.

You may qualify if:

  • Age between 18-65 years
  • Time after amputation ≥ 6 months
  • Unilateral transfemoral traumatic amputation

You may not qualify if:

  • Bilateral transfemoral amputation
  • Unilateral non-traumatic transfemoral amputation
  • Presence of neurological, auditory, or vision-related disease that may affect balance and proprioception
  • Presence of cardiovascular or pulmonary disease that will affect muscle strength

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kilinc Kamaci G, Orucu Atar M, Ozcan F, Demir Y, Aydemir K. Relationship of stump length with muscle strength, proprioception, and balance in patients with traumatic unilateral transfemoral amputation. Prosthet Orthot Int. 2024 Dec 18;49(3):268-273. doi: 10.1097/PXR.0000000000000385.

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Gizem Kılınç Kamacı, MD

    Specialist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gizem Kılınç Kamacı, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

July 18, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06