Clinical trial NCT05435326: The Relationship of Stump Length With Muscle Strength in Patients With Traumatic Unilateral Transfemoral Amputation
Official title: The Relationship of Stump Length With Muscle Strength, Balance, and Proprioception in Patients With Traumatic Unilateral Transfemoral Amputation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation, Traumatic
Keywords: amputation
stump length
muscle strength
balance
proprioception
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: The isokinetic muscle strength of the hip extensors and flexors
timeFrame: through study completion, an average of one month
Secondary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: through study completion, an average of one month
measure: Proprioception assessment
timeFrame: through study completion, an average of one month
Other outcomes:
Locations:
Study officials:
affiliation: Specialist
name: Gizem Kılınç Kamacı, MD
role: PRINCIPAL_INVESTIGATOR
References: