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NCT06046300

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

Status unknown Last updated 6 October 2023
What this trial tests

trial testing Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. in Amputation in 30 participants. Status unknown.

Timeline
15 February 2025
Primary endpoint
25 September 2025
25 October 2025

Quick facts

Lead sponsorHacettepe University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment30
Start date15 February 2025
Primary completion25 September 2025
Estimated completion25 October 2025
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Hacettepe University

Who can join

Adults 18 to 45, any sex, with Amputation or Muscle Activation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Amputation

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06046300.

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