Clinical trial NCT06266637: Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics
Official title: Effect of Physiotherapeutic Scoliosis-Specific Exercise on Lower Limb Biomechanics in Adolescents With Idiopathic Scoliosis: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic
Keywords: scoliosis
exercise
lower limb
biomechanics
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2024-02-20
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.

HYPOTHESES:

Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.

RESEARCH QUESTION:

What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?

Detailed description: procedures: A randomized controlled clinical trial will be conducted

Assessment:

x-ray computed scanogram radiography of the whole spine and both lower limbs in standing will be used.

The following measurements will be taken pre and post the treatment program:

For the lumbar spine coronal alignment:

1. Cobb's angle for dorso-lumbar scoliosis (curve apex from D10- L4) will be measured.
2. Coronal balance estimated by the distance between plumb line and central sacral line from anterioposterior x-ray view

For both lower limbs:

1. the length will be measured for the limb, the tibia and the femur
2. tibiofemoral angle
3. joint line convergence angle
4. mechanical axis
5. mechanical axis deviation

Treatment:

Patients will be randomly assigned into two groups to receive the prescribed treatment program for 6 months., 1 session per week in addition to a home program of daily exercise .

The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .

The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise

Data will be analyzed using 2 way MANOVA.

Eligibility criteria: Inclusion Criteria:

* Adolescents with age 10-18 years
* complaining of dorsolumbar scoliosis
* curves (apex lies between D10 and L4)
* curve magnitudes greater than 15 degrees and less than 90
* using or not using brace
* all maturity levels (Risser = 0-5)

Exclusion Criteria:

* Other types of scoliosis ; congenital or neuromuscular
* Current physical therapy or medical treatment for scoliosis,
* Contracture or surgery affecting the lumbar spine or lower limbs
* Pathologies such as inflammatory diseases
* congenital anomalies
* Neurological disorders like cerebral palsy or ataxia
* dislocations
* visual or auditory problems

Primary outcomes:
measure: Cobb's angle
timeFrame: From enrollment to the end of treatment at 6 months
measure: Coronal balance
timeFrame: From enrollment to the end of treatment at 6 months
measure: length of the the tibia and femur
timeFrame: From enrollment to the end of treatment at 6 months
measure: tibiofemoral angle
timeFrame: From enrollment to the end of treatment at 6 months
measure: knee joint line convergence angle
timeFrame: From enrollment to the end of treatment at 6 months
measure: lower limb mechanical axis; and mechanical axis deviation
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta university for science and technology
state: Dakahleya
Study officials:
References: