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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amputation, Traumatic

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.

• Study Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

• Study Contact: Name: Gizem Kılınç Kamacı, MD; Phone Number: 03122912413; Email: kilinc_gizem@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Gizem Kılınç Kamacı, MD, Specialist

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: muscle strength; proprioception; balance; amputation; stump length
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No