Interventional Study on Gait Biomechanics and Posture Walking in Women with Low Back and Pelvic Pain

JRCT ID: jRCT1062240091

Registered date:13/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: low back pain/ pelvic girdle pain
• Date of first enrollment: 13/12/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

In this study, women with pelvic girdle pain (PGP) will participate in posture walking training sessions.
Posture walking is a walking method that emphasizes maintaining proper posture. By walking with correct posture, the core and lower limb muscles are engaged effectively, particularly the core muscles (abdominal and back muscles), enhancing overall stability. Posture walking focuses on aligning all body parts, from head to toes, to maintain a balanced posture. This approach reduces the strain on the body, enabling more efficient walking. Consequently, it can help alleviate joint and muscle strain, preventing conditions like low back pain and knee pain.

### Training Sessions
The posture walking training consists of three sessions over two months, with each session lasting 45 minutes. The first session will be conducted in person at the measurement site, while the second and third sessions will be delivered online using a video conferencing system. Details about the online sessions are outlined below:

### How to Attend Online Sessions
#### Reservation Procedure
- **Input through a reservation form**: Participants will receive a link to a Google Form during the first session. The form will require the participant's ID number, email address, and preferred dates/times for the session. Participants can select from the available options.

#### Session Delivery
1. **Platform**: Zoom will be used for online sessions.
2. **Guidance**: Participants will receive an email with the session schedule, meeting link, and preparation instructions in advance.

#### Flow on the Day of the Session
1. **Preparation**: Participants should access the meeting link before the session starts.
2. **Session**: Each session will last for 45 minutes.
3. **Display Name**: Participants' Zoom display names will remain hidden for privacy.

Outcome(s)

• Primary Outcome: Fear-Avoidance Beliefs Score (FABQ)

Secondary Outcome

- Subjective Well-Being
Change rate before and after intervention (using markerless motion capture to analyze gait patterns).
- Peak Hip Flexor Moment
- Total Hip Work and Hip Contribution to Work
- Hip Inclination Angle
- Aesthetic Score (ordinal variable)
- Gait Interval, Gait Stride Width, Gait Center of Gravity Width

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Female

Include criteria

1. Individuals who can visit the designated measurement venue (on the premises of Okayama University Hospital) between the date of approval by the head of the research institution and September 30, 2026.
2. Individuals who can provide informed consent to participate in the study of their own free will.
3. Women aged 18 to under 60 years at the time of consent.
4. Women weighing less than 100 kg.
5. Women capable of independent walking without the use of walking aids such as canes.
6. Women who can communicate without difficulty in Japanese.

Exclude criteria

1. Women who have undergone knee or hip surgery within the past 3 months.
2. Women with neuromuscular diseases (e.g., Parkinson's disease, multiple sclerosis).
3. Pregnant women.
4. Women who have experienced pelvic fractures, vertebral fractures, or femoral fractures within the past 6 months.
5. Women with physical pain requiring medical treatment by a healthcare provider.
6. Women with a history of myocardial infarction within the past 2 years.
7. Women with untreated or severe cardiac conditions, including moderate to severe aortic stenosis, acute pericarditis, aortic aneurysm, symptomatic angina, symptomatic valvular disease, untreated arrhythmia, or intermittent claudication.
8. Women with uncontrolled atrial fibrillation.
9. Women with a history of cerebral infarction within the past 2 years.
10. Women with respiratory dysfunction:
- (1) Users of home oxygen therapy.
- (2) Under treatment for airway-obstructive diseases (e.g., thyroid tumors or other metastatic tumors causing airway obstruction).
11. Women with severe renal impairment requiring dialysis.
12. Women with resting systolic blood pressure >200 mmHg or resting diastolic blood pressure >100 mmHg.
13. Others deemed unsuitable for the study by the principal investigator due to insufficient understanding of the study content or objections to the study.

Related Information

• Primary Sponsor: MAKI JOTA