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Status unknownNCT05435326Updated Jun 28, 2022

The Relationship of Stump Length With Muscle Strength in Patients With Traumatic Unilateral Transfemoral Amputation

An observational study in Amputation, Traumatic, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Status unknown. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
16
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the detailed description

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.

People with unilateral transfemoral amputation have lost their knee and ankle joint.

This causes a loss of proprioceptive feedback from the ankle joint, knee joint and related muscles. Muscle weakness, muscle atrophy and balance problems are common in amputee patients.

There is not enough data to reveal the relationship between stump length and muscle strength, balance, and proprioception. The aim of this study to evaluate the relationship of stump length with muscle strength, balance, and proprioception in patients with traumatic unilateral transfemoral amputation.

02

Conditions studied

  • Amputation, Traumatic

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Keywords

  • amputation
  • stump length
  • muscle strength
  • balance
  • proprioception
03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's planned enrollment of 16 is below the median of 37 across 34 observational studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
16 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: through study completion, an average of one month

Secondary outcomes

  1. The Berg Balance Scale (BBS)

    The balance will be evaluated using the Berg Balance Scale (BBS). The BBS is a clinical test commonly used to assess the patients' static and dynamic balance performance. Berg Balance Scale consist of 14 items. A participant's performance on each task is graded using a 5-point ordinal scale ranging from 0 to 4. Total score of scale is 0-56 points. The higher the scores show the better the balance ability of the patients.

    Time frame: through study completion, an average of one month

  2. Proprioception assessment

    The computer-assisted isokinetic system (CYBEX) will be also used to evaluate the lower extremity proprioceptive sense of patients. The average proprioceptive errors at 15-45° and 30-60° were assessed. Patients will be taught the initial 15° and the targeted 45° hip flexion angles by keeping hip in these angles for 10 seconds. Afterwards, patients will be asked to move from the initial 15° to the target 45° while their eyes are closed. The average proprioceptive errors which are deviations from target angles will be noted. The same procedure will be done for initial 30° and target 60° angles.

    Time frame: through study completion, an average of one month

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Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2022; primary completion for Sep 2022, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Jun 28, 2022
StartEst.
Jul 18, 2022
Primary completionEst.
Sep 15, 2022
CompletionEst.
Sep 15, 2022
Last update
Jun 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05435326
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Yasin Demir (Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Jun 28, 2022
Start date
Jul 18, 2022 (estimated)
Primary completion
Sep 15, 2022 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Jun 28, 2022

Study contacts

Gizem Kılınç Kamacı, MD
Contact
kilinc_gizem@hotmail.com
03122912413
Gizem Kılınç Kamacı, MD
principal investigator · Specialist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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