Patient Reported OutcomeNCT05177302
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 3
An observational study of Patient Reported Outcome, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Patient Reported Outcome
- What is being tested?
- HAGOS-C and SF-36v2
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The individuals with long-standing hip and/ or groin pain lasting 2 to 6 month, which hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint, and tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis will be included . The individuals with other symptoms in lumbar, knee or ankle joint will be excluded.
Who may be able to join
- 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.
Who cannot join
- other symptoms in lumbar, knee or ankle joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(3)
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.
Read the detailed description
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.
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.
- Conditions
- Patient Reported Outcome
- Being tested
- HAGOS-C, SF-36v2
- Keywords
- hip and/ or groin pain, reliability, validity, responsiveness, HAGOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAGOS-COther
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
SF-36v2Other
The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HAGOS-C; Other: SF-36v2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAGOS-C
The individuals will be asked to complete 37 items of the HAGOS-C after instruction
Measured: immediately after the intervention
SF-36v2
The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation
Measured: immediately after the intervention
HAGOS-C
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.
Measured: after 1 week
HAGOS-C
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness
Measured: after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Mar 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported OutcomeStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, Ph.D, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177302
- Sponsor's protocol ID
- YM110027E(3)
- Status last verified
- Nov 2023
- First submitted
- 2 Dec 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(3)
- ClinicalTrials.gov ID
- NCT05177302
- Acronym / sponsor ID
- YM110027E(3)
- Conditions
- Patient Reported Outcome
- Keywords
- hip and/ or groin pain, reliability, validity, responsiveness, HAGOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with hip and/ or groin pain | – | Other: HAGOS-C, Other: SF-36v2The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The individuals with long-standing hip and/ or groin pain lasting 2 to 6 month, which hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint, and tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis will be included . The individuals with other symptoms in lumbar, knee or ankle joint will be excluded.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- other symptoms in lumbar, knee or ankle joint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAGOS-CThe 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 | Individuals with hip and/ or groin pain |
| SF-36v2The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C | Other | Individuals with hip and/ or groin pain |
Primary outcome
HAGOS-C
Time frame: immediately after the intervention
The individuals will be asked to complete 37 items of the HAGOS-C after instruction
SF-36v2
Time frame: immediately after the intervention
The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation
HAGOS-C
Time frame: after 1 week
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.
HAGOS-C
Time frame: after 4 months
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Fen Shih, Ph.D study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcome, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAGOS-C (time frame: immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.