NCT06759415

Brief Summary

Adolescent Idiopathic Scoliosis (AIS) is a prevalent three-dimensional torsional disorder, primarily affecting adolescents during puberty. Characterized by a lateral deviation of the spine greater than 10°, AIS can lead to physical and psychological issues, including back pain, cosmetic deformity, and reduced quality of life. This study aims to compare the effects of Proprioceptive Neuromuscular Facilitation (PNF) techniques and Core Stabilization exercises on physical and functional parameters in adolescents with idiopathic scoliosis. This randomized controlled trial was conducted with 52 adolescents aged 10-18 years, diagnosed with AIS (Cobb angle of 10-30°). Participants were randomly assigned to either the PNF group or the Core Stabilization group. Both groups underwent a 10-week supervised exercise program, supplemented by a home exercise regimen. Primary outcomes included changes in the Cobb angle and Angle of Trunk Rotation (ATR). Secondary outcomes assessed quality of life (SRS-22), perceived trunk appearance (WRVAS), and physical function (6MWT and STS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 5, 2024

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cobb

    The Cobb: Lines are drawn parallel to the upper edge of the superior vertebra and the lower edge of the inferior vertebra. Then, perpendicular lines are drawn to these parallel lines, and the angle between the two perpendiculars is measured. This angle, known as the Cobb angle, indicates the degree of scoliosis.

    24 weeks

Secondary Outcomes (3)

  • The Walter Reed Visual Assessment Scale

    24 weeks

  • Trunk Rotation Angle,

    24 weeks

  • Scoliosis Research Society-22

    24 weeks

Study Arms (2)

PNF group

ACTIVE COMPARATOR

Proprioceptive Neuromuscular Facilitation Group: The Proprioceptive Neuromuscular Facilitation (PNF) PNF exercises focused on enhancing neuromuscular control, flexibility, and strength of the spinal and core muscles. The exercise regimen included spiral and diagonal movement patterns, rhythmic stabilization, and contract-relax techniques. Participants were instructed on the activation of the transverse abdominus (TrA) muscle, starting with palpation techniques to feel the muscle contraction. Exercises progressed from supine positions to more challenging postures, incorporating breathing control to avoid the Valsalva maneuver.

Other: Exercise

core stabilization group

ACTIVE COMPARATOR

Core Stabilization Group: The core stabilization exercises aimed to improve the stability and strength of the core muscles, which are crucial for maintaining spinal alignment and posture. The exercise regimen included static and dynamic postural control exercises, balance training, and functional movement patterns. The core stabilization exercises focused on strengthening the deep trunk muscles, including the transverse abdominis, multifidus, and pelvic floor muscles.

Other: Exercise

Interventions

Exercise therapy was applied to individuals in both groups.

PNF groupcore stabilization group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged between 10 and 18 years old,
  • First-time diagnosis of AIS,
  • Risser sign of 0-3 and a Cobb angle of 10-30°,
  • Sanders classification of 0-6,
  • Lenke curve Type 1 or Type 1A,
  • Volunteered to participate in the study.

You may not qualify if:

  • The presence of other types of scoliosis (e.g., congenital or neuromuscular scoliosis),
  • a history of spinal surgery,
  • use of a brace,
  • contraindications for exercise (e.g., cardiovascular or respiratory disorders),
  • previous AIS treatment,
  • rheumatological diseases, and/or other neuromuscular problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Hanifi KAYA

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor did not know which group the participants were in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the PNF group or the core stabilization group using a computer-generated randomization list to ensure equal distribution of participants across the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pilot Project Manager Lecturer Doctor.

Study Record Dates

First Submitted

June 5, 2024

First Posted

January 6, 2025

Study Start

January 12, 2022

Primary Completion

December 15, 2022

Study Completion

February 10, 2023

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations