NCT07109037

Brief Summary

This study aims to compare the effects of suspension exercise therapy combined with conventional exercise therapy and conventional exercise therapy alone on pain, Cobb angle, functional impairment, and quality of life in adult patients with idiopathic scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

April 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 24, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Sling exercise trainingExercise therapyAdultIdiopathic scoliosis

Outcome Measures

Primary Outcomes (1)

  • Cobb angle

    The measurements and evaluations were conducted on the first day of treatment and after the completion of the 30 - day treatment respectively.

Secondary Outcomes (3)

  • Oswestry Disability Index

    The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

  • Pain score (Visual Analogue Scale, VAS)

    The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

  • Quality of life assessment (Scoliosis Research Society - 22 questionnaire, SRS - 22)

    The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.

Study Arms (2)

Conventional exercise therapy group

ACTIVE COMPARATOR

Conventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes .

Other: Conventional exercise therapy

Combined Intervention group

EXPERIMENTAL

Suspension training and conventional exercise therapy

Other: Suspension training and conventional exercise therapy

Interventions

Conventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes .

Conventional exercise therapy group

Suspension training alternates with conventional exercise therapy. It is conducted every other day, 45 minutes each time, 2-3 times a week for four consecutive weeks. Elastic ropes for suspension training are chosen based on patients' body mass: single - strand for those with body mass ≤ 30 kg and double - strand for those with body mass \> 30 kg. Suspension slings are placed on the head, lower back, and pelvis, and non-elastic rope slings on the ankles. Lower the lifting bed so that the vertical distance from the ankles to the bed surface is about 25-30 cm.

Combined Intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the anteroposterior and lateral X-ray films of the spine in the standing position, the Cobb angle is ≥10° and \<40°
  • The age ranges from 18 to 75 years old
  • No previous history of surgery
  • Not wearing a corrective brace

You may not qualify if:

  • Having mental illnesses
  • Having severe cognitive and communication disorders
  • Having severe cardiopulmonary dysfunction or cardiovascular diseases
  • Having adult degenerative and secondary scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power-sling suspension device (SPS-F11, Nanjing Sbird Biotechnology Co., Ltd.)

Neijiang, Sichuan, 642450, China

Location

Related Publications (2)

  • Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.

    PMID: 35859288BACKGROUND
  • Zhou Z, Liu F, Li R, Chen X. The effects of exercise therapy on adolescent idiopathic scoliosis: An overview of systematic reviews and meta-analyses. Complement Ther Med. 2021 May;58:102697. doi: 10.1016/j.ctim.2021.102697. Epub 2021 Feb 23.

    PMID: 33636298BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 7, 2025

Study Start

April 25, 2025

Primary Completion

May 25, 2025

Study Completion

June 27, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

In order to protect the patients' personal privacy from infringement and to make this part of data available for subsequent research.

Locations