The Relationship Between Trunk Position Sense and Muscle Activation, Balance and Quality of Life in Amputees

NCT06046300 | Unknown

• 1 other identifier: GO 21/1104
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to examine the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. Individuals with unilateral transtibial amputation who have been using prostheses for at least 1 year and volunteered to participate in the study, as well as healthy individuals with similar demographic characteristics will be included in the study. The number of cases considered to be included in the study will be obtained from the statistical analysis of the results of the pilot study to be conducted with 5 individuals, since there is no study on the subject. The power of the study will be determined as 0.80. After determining the number of individuals to be included in the study group, a control group will be formed with the same number of healthy individuals. The study will be terminated when the determined total number of participants is reached. Body position sense, trunk muscle activation, static and dynamic balance performances and quality of life of all individuals will be evaluated. Body position sense of individuals with "Dualer IQ Pro Digital Inclinometer" device, trunk muscle activation with "Delsys Trigno IM wireless surface electromyography (sEMG) system", balance with "Bertec balance platform", balance and functional mobility with "Berg Balance Scale (BDI) ", "Timed Up and Go Test (SKYT)" and "Modified Star Excursion Test (SEBT)" and quality of life will be evaluated with "Trinity Amputation and Prosthesis Experience Scale (TAPES)". As a result of our study, investigators think that it will contribute to the current scientific knowledge about the somatosensory and biomechanical mechanisms underlying the abnormalities that occur in the trunk after transtibial amputation, to determine whether the trunk position sense of individuals with transtibial amputation is affected or not, and to determine the relationship between trunk position sense and muscle activation, balance and quality of life.

Conditions

Amputation; Muscle Activation; Balance; Quality of Life; Sense of Control

Keywords

Transtibial amputation; Sense of position; Muscle activation; Balance; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Trunk Position Sense measurement

  Thanks to dual-sensor measurement with Dualer IQ Pro Digital Inclinometer, spine evaluations can be made by collecting easy and reliable data. The device is recommended by the American Medical Association (AMA). It is a calibrated device with a 1 degree margin of error, used in the measurement of joint range of motion and position sense in the clinic. It determines the potential difference between the two end heads and converts this potential difference to the corresponding joint angle to measure the range of motion of the spine and limbs without a computer.

  30 minutes

Secondary Outcomes (1)

• Trunk Muscle Activation measurement

  30 minutes

Other Outcomes (2)

• Balance measurement

  30 minutes

• Quality of Life measurement

  30 minutes

Study Arms (2)

Amputees

Individuals with a transtibial amputation

Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.

Healthy

Healthy individuals

Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.

Interventions

Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. DIAGNOSTIC_TEST

It is aimed to investigate whether the trunk position sense, including the trunk right and left sides of the individuals with transtibial amputation, is affected and the relationship between trunk position sense and muscle activation, balance and quality of life.

Amputees; Healthy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study group consisted of individuals with transtibial amputation who volunteered to participate in the study and came to Hacettepe University Faculty of Physical Therapy and Rehabilitation, Prosthesis-Orthotics and Biomechanics Unit and Bilim Orthotics Prosthesis Center; The control group will consist of healthy individuals in the immediate vicinity who volunteered to participate in the study.

You may qualify if:

• For Transtibial Amputation Group;
• Having a traumatic unilateral transtibial amputation,
• Using prosthesis for at least 1 year,
• K2 and K3 functional classification according to K level,
• Between the ages of 18-45,
• Having received standard physiotherapy methods (prosthesis training),
• It was determined as individuals who volunteered to participate in the study. For the Healthy Group;
• Between the ages of 18-45,
• Having similar demographic characteristics with the individuals in the transtibial amputee group,
• No neurological and/or orthopedic problems,
• Individuals who agreed to participate in the study voluntarily.

You may not qualify if:

• For both groups;
• Having hip, knee or ankle joint limitation,
• Having muscle shortness that prevents walking and other activities,
• Having a history of falling in the last 1 year,
• Body mass index (BMI) \>30 kg/m²,
• Individuals using a walking aid. For the Amputation Group;
• Having phantom pain,
• Individuals with any disease or systemic health problem that may affect their gait other than amputation.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06, Turkey (Türkiye)

Location

Study Officials

• Ozlem Ulger

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Semra TOPUZ

CONTACT

03123051576; fztsemra@yahoo.com

Hüseyin ÇELİK

CONTACT

05056642631; fzthuseyincelik@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSC, Clinical Professor

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: February 15, 2025
• Primary Completion: September 25, 2025
• Study Completion: October 25, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)