- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07593183
Comparing the Effects of Lumbar Stability Exercises and Telerehabilitation on Reducing Lumbar Lordotic Angle, Pain, and Disability in Postpartum Women
연구 개요
상세 설명
Group A will undergo 6 weeks onsite lumbar stabilization protocols and Group B will undergo 6 weeks telerehab lumbar stabilization protocols, both groups will undergo 3 sessions per week on alternate day. Both groups will have educational session on the pre-assessment day. Then group a Group A will undergo onsite lumbar stabilization protocols in-front of therapist while Group B will receive exercise session video and group B will perform exercise during live call with the therapist. There will be 5 minutes warm up period before each session in which quick rhythmic movement of the body will be perform. A cool down period will be performed after each session in which adductor stretch, iliopsoas stretch will be performed.
Week 1-2 Core awareness & activation In week 1, diaphragmatic breathing, abdominal drawing-in maneuvers 30 seconds to 1 minute, and pelvic floor contraction. In week 2, pelvic tilting in supine, supine line heel slide, supine lying marching will be added. Perform it ten times per set, 1 sets a day. The set and repetition will be increase progressively according to individual stamina.
Week 3-4 Core Stabilizing excercise Continue week 1-2 maneuvers but in addition with glutes bridges, quadrupled bird dog, clamshells. Perform it ten times per set, 1 sets a day. The set and repetition will be increase progressively according to individual stamina.
Week 5-6 Functional Activity Modified side plank, modified front planks, modified squatting, lunges. Perform it 5 times per set, 1 sets a day. The set and repetition will be increase progressively according to individual stamina.
Diaphragmatic breathing Patient will be hook lying in supine position. Therapist will give cue to patient to place one hand on the chest and other hand below the ribs and take slow breath in through your nose for 2-3 sec and let the ribs expand sideways and allow the belly to gently rise after that exhale slowly through the mouth, like blowing the candle.
Abdominal bracing Patient will be hook lying in supine position. Patient will place her hand on the lateral side of the abdominal wall. Therapist will give cue take breath in and now breath out, as you breathe out gently draw your belly button in and up. Patient will feel firming under the fingers Pelvic floor contraction Patient will be hook lying in supine position. Therapist will give cue to patient that think of tightening the pelvic floor upward in order to stop the flow of urine 10midstream. As you breath squeeze and lift the pelvic floor muscle hold for 5 second and then relax for 5 seconds Pelvic tilting Patient will be hook lying in supine position. Patient will take breath in and patient will gently flatten the lower back on the floor. Therapist will give cues to patient that imagine, there is sheet place under your lower back and I'm pulling it so you will flatten your lower back and will not let it go.
Supine lying heel slide Patient will be hook lying in supine position on her back, with knee bent and arms relaxed neutral spine. Patient will engage her core by abdominal bracing and then slide her one foot will keeping her heel on the mat, straightening her leg and then bend her knee. Same will be performed on her alternate leg.
Supine lying marching Patient will be hook lying in supine position on her back, with knee bent and arms relaxed neutral spine. Patient will engage her core by abdominal bracing and then lift her one foot off the floor , bringing the knee toward the chest Same will be perform on her alternate leg.
Glutes bridge Patient will be hook lying in supine position on her back, with knee bent and arms relaxed neutral spine. Patient will position her heels close to body squeeze her glutes and then drive her hip up from the floor, and will continue lifting until her body form a straight line from shoulder to knee and then slowly lower her hip back to starting position.
Quadrupled bird dog Patient will be on hand and knee on floor. Hand will be directly under the shoulders and knee will directly under the hips. Patient will brace her abdominal and slowly lift her arm and alternate leg and extend it while maintain stability. She will hold this position for few second and then return to starting position. Same will be performed on alternate side.
Clamshell Patient will be lying on her side with her knee bent while keeping her feet together, she will slowly lift her top knee toward the ceiling, rotating the hip and then slowing return to starting position. Same will be perform on alternate side Modified Side plank Patient will be lying on her side with her knee bent at 90 degree and place her elbow directly under the shoulder. While bracing her abdominal, patient will lift her body from the floor until her body is at straight alignment and hold it for 10 second and then return to start position.
Modified plank Patient will lie prone on the mat while her knee bent and elbow directly under her shoulder and will lift her hips off the floor and will keep her body in the straight alignment. She will hold this position for 10 second while breathing steadily Modified squatting Patient will stand with their back against a wall. Feet will be placed few inches apart from the walls and will be directly under the hip level. Then patient will slowly slide her back down by bending her hips and knee at the angle of 45 degree knee bent. She will hold this position for the 10 second and then return to start position Modified lunges Patient will stand upright with the feet hip-width apart and she will place her one foot forward and the other foot back, keeping both feet pointing straight ahead and will be holding chair for the balance. She will slowly bend both her knees, while lowering her body straight down. Therapist will give cues that keep your front knee inline the ankle and don't move past your toes. She will hold this position for the 10 second and then return to start position.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hafiz Ali Bin Asim, MS-SPT
- 전화번호: 03135088144
- 이메일: pt.ali.asim@gmail.com
연구 연락처 백업
- 이름: Ayesha Khan, DPT
- 전화번호: 03025220691
- 이메일: Ayeshakh877@gmail.com
연구 장소
-
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Punjab Province
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Islamabad, Punjab Province, 파키스탄, 44000
- 모병
- Foundation University College of Physical Therapy
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연락하다:
- Ayesha Khan, DPT
- 전화번호: 03025220691
- 이메일: Ayeshakh877@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female participants 6 weeks up to 12 month post-partum women.
- Participants who has access to internet services and technologies
- Participants with mild-to-moderate self-reported low back pain for at least 2 weeks.
- Objectively measured lumbar lordotic angle beyond normative range of 40 Degree
Exclusion Criteria:
- Congenital spine deformities like scoliosis
- Pelvic prolapsed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Group A; Lumbar Stabilization
Group A will undergo 6 weeks onsite lumbar stabilization protocols in front of the therapist and will undergo 3 sessions per week on alternate day. It will have educational session on the pre-assessment day. There will be 5 minutes warm up period before each session in which quick rhythmic movement of the body will be perform. A cool down period will be performed after each session in which adductor stretch, iliopsoas stretch will be performed. Week 1-2 Core awareness & activation In week 1, diaphragmatic breathing, abdominal drawing-in maneuvers 30 seconds to 1 minute, and pelvic floor contraction. In week 2, pelvic tilting in supine, supine line heel slide, supine lying marching will be added. Perform it ten times per set, 1 sets a day. Week 3-4 Core Stabilizing exercise Continue week 1-2 maneuvers but in addition with glutes bridges, quadrupled bird dog, clamshells. Week 5-6 Functional Activity Modified side plank, modified front planks, modified squatting, lunges. |
Group A will undergo 6 weeks onsite lumbar stabilization protocols in front of the therapist and will undergo 3 sessions per week on alternate day. It will have educational session on the pre-assessment day. There will be 5 minutes warm up period before each session in which quick rhythmic movement of the body will be perform. A cool down period will be performed after each session in which adductor stretch, iliopsoas stretch will be performed. Week 1-2 Core awareness & activation In week 1, diaphragmatic breathing, abdominal drawing-in maneuvers 30 seconds to 1 minute, and pelvic floor contraction. In week 2, pelvic tilting in supine, supine line heel slide, supine lying marching will be added. Perform it ten times per set, 1 sets a day. The set and repetition will be increase progressively according to individual stamina. Week 3-4 Core Stabilizing exercise Continue week 1-2 maneuvers but in addition with glutes bridges, quadrupled bird dog, clamshells. |
|
실험적: Group B; Telerehabilitation
Group B will undergo 6 weeks telerehab lumbar stabilization protocols, will undergo 3 sessions per week on alternate day. Then group B will receive exercise session video and group B will perform exercise during live call with the therapist. There will be 5 minutes warm up period before each session in which quick rhythmic movement of the body will be perform. A cool down period will be performed after each session in which adductor stretch, iliopsoas stretch will be performed. Week 1-2 Core awareness & activation In week 1, diaphragmatic breathing, abdominal drawing-in maneuvers 30 seconds to 1 minute, and pelvic floor contraction. In week 2, pelvic tilting in supine, supine line heel slide, supine lying marching will be added. Week 3-4 Core Stabilizing exercise Continue week 1-2 maneuvers but in addition with glutes bridges, quadrupled bird dog, clamshells. Perform it ten times per set, 1 sets a day. |
Group B will undergo 6 weeks telerehab lumbar stabilization protocols, will undergo 3 sessions per week on alternate day. It will have educational session on the pre-assessment day. Then group B will receive exercise session video and group B will perform exercise during live call with the therapist. There will be 5 minutes warm up period before each session in which quick rhythmic movement of the body will be perform. A cool down period will be performed after each session in which adductor stretch, iliopsoas stretch will be performed. Week 1-2 Core awareness & activation In week 1, diaphragmatic breathing, abdominal drawing-in maneuvers 30 seconds to 1 minute, and pelvic floor contraction. In week 2, pelvic tilting in supine, supine line heel slide, supine lying marching will be added. Perform it ten times per set, 1 sets a day. The set and repetition will be increase progressively according to individual stamina. Week 3-4 Core Stabilizing exercise. Week 5-6 Functional Activity |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lumbar Pain Intensity
기간: baseline and post-intervention (week6)
|
It will be measured by numeric pain rating scale in which patients rate their pain from 0 (no pain) to 10 (worst pain imaginable).
|
baseline and post-intervention (week6)
|
|
Lumbar Disability
기간: baseline and post-intervention (week6)
|
It will be measured by Oswestry Disability Index(ODI) which reliable and valid self-administered questionnaire consisting of 10 sections to assess level of disability in patients.
|
baseline and post-intervention (week6)
|
|
Lumbar Lordotic Angle
기간: baseline and post-intervention (week6)
|
Lumbar Lordotic Angle is measured through Flexicurve method.
The spinous processes of T12 (as the starting point) and S2 (as the endpoint) were identified through palpation by an evaluator during the assessment of spinal curvature.
While contouring the flexicurve along the spine, the locations of the T12 and S1 spinous processes were marked using the instrument's integrated metric scale.
Once the flexicurve was molded to match the spinal curvature, it was carefully removed, and its internal edge previously in contact with the skin was traced onto graph paper.
This tracing represented the lumbar curvature in the sagittal plane, with the relevant spinous processes clearly marked.
A vertical line was drawn between T12 and S2, and the deepest point of the curve was used to draw a perpendicular line to calculate the depth.
These measurements were used to assess lumbar curvature.
Formula θ=4Arctan 2H/L Whereas 'L' is the length of the spine segment and 'H' is the maximum depth of the curve.
|
baseline and post-intervention (week6)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ayesha Khan, DPT, Foundation University Islamabad
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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