Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 3

Sponsor

National Yang Ming University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05177302

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al.

Condition or Disease	Intervention/Treatment	Phase
Patient Reported Outcome	Other: HAGOS-C Other: SF-36v2

Detailed Description

We translated the questionnaire from the English version involved following steps: (1)initial translation with two bilingual translators (2) holding consensus meeting for the preliminary Chinese version (3) back translation with other two bilingual back translators (4) another consensus meeting for ensuring the consistency with original English version (5) pretesting for wording and understanding (6) Wording, rephrasing and format corrected to obtain final Chinese version of the HAGOS.

The aim of the study is to determine the validity, reliability and responsiveness of HAGOS-C by recruiting young to middle-aged physically active individuals with long-standing hip and/ or groin pain.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(3)

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Individuals with hip and/ or groin pain The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month.	Other: HAGOS-C The subjects will be instructed to complete HAGOS-C at the initial contact and again after 1 week and 4 month for reliability and responsiveness test, respectively Other: SF-36v2 The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C

Arm

Intervention/Treatment

Individuals with hip and/ or groin pain

The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month.

Other: HAGOS-C

The subjects will be instructed to complete HAGOS-C at the initial contact and again after 1 week and 4 month for reliability and responsiveness test, respectively

Other: SF-36v2

The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C

Outcome Measures

Primary Outcome Measures

HAGOS-C [immediately after the intervention]
The individuals will be asked to complete 37 items of the HAGOS-C after instruction
SF-36v2 [immediately after the intervention]
The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation
HAGOS-C [after 1 week]
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.
HAGOS-C [after 4 months]
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

physically active at least 2.5 hrs/week
tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis
hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint.
pain lasting for 2 to 6 month and no obvious changes within 3 week recently.

Exclusion Criteria:

other symptoms in lumbar, knee or ankle joint.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Yang Ming University	Taipei		Taiwan	11221

Sponsors and Collaborators

National Yang Ming University

Investigators

Study Director: Yi-Fen Shih, Ph.D, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi-Fen Shih, Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT05177302

Other Study ID Numbers:

YM110027E(3)

First Posted:

Jan 4, 2022

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yi-Fen Shih, Professor, National Yang Ming University

hip and/ or groin pain

Study Results

No Results Posted as of Mar 23, 2022