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

Amputation, Traumatic Clinical Trial

Official title:

The Relationship of Stump Length With Muscle Strength, Balance, and Proprioception in Patients With Traumatic Unilateral Transfemoral Amputation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05435326
• Other study ID #: 28
• Status: Not yet recruiting
• Start date: July 18, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2022
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Gizem Kilinç Kamaci, MD
• Phone: 03122912413
• Email: kilinc_gizem[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	through study completion, an average of one month
Secondary	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.	through study completion, an average of one month