- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07593183
Comparing the Effects of Lumbar Stability Exercises and Telerehabilitation on Reducing Lumbar Lordotic Angle, Pain, and Disability in Postpartum Women
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hafiz Ali Bin Asim, MS-SPT
- Telefonní číslo: 03135088144
- E-mail: pt.ali.asim@gmail.com
Studijní záloha kontaktů
- Jméno: Ayesha Khan, DPT
- Telefonní číslo: 03025220691
- E-mail: Ayeshakh877@gmail.com
Studijní místa
-
-
Punjab Province
-
Islamabad, Punjab Province, Pákistán, 44000
- Nábor
- Foundation University College of Physical Therapy
-
Kontakt:
- Ayesha Khan, DPT
- Telefonní číslo: 03025220691
- E-mail: Ayeshakh877@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Lumbar Pain Intensity
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ayesha Khan, DPT, Foundation University Islamabad
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Bolesti zad
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolesti v kříži
- Správa zdravotnických služeb
- Poskytování zdravotní péče
- Terapeutika
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Telemedicína
- Řízení péče o pacienty
- Telerehabilitace
Další identifikační čísla studie
- FUI/FUCP/CTR/08.26/Ayesha Khan
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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