Scoliosis; AdolescenceNCT06416592
Reliability and Validity of Hand Dynamometer Trunk Muscle Strength Measurements in Patients With AIS
An observational study of Scoliosis; Adolescence and Adolescent Idiopathic Scoliosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Adolescent Idiopathic Scoliosis
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 10 Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent idiopathic scoliosis patients
Who may be able to join
- Being between the ages of 10-18
- Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
- Ability to understand instructions
- Volunteering to participate in the study
Who cannot join
- History of traumatic trunk or pelvic injury
- History of acute, subacute or chronic low back pain or neurological disease
- Having had spinal surgery
- Participating in heavy physical activity at least one day before the test days
- Having experienced any acute situation that could affect muscle strength between the two tests (within 7 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-rater and Inter-rater Reliability and Validity of Hand Dynamometer Trunk Flexor, Extensor and Lateral Flexor Muscle Strength Measurements in Patients With Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane. It has been reported that in the presence of scoliosis, there is a change in muscle strength of people compared to their healthy peers due to the deterioration of their postural balance. There are many studies in the literature that evaluate the muscle strength of cases diagnosed with scoliosis with objective devices. Among these objective devices, reliability studies on hand dynamometry devices, which are easy to use, portable and cheaper than other devices, have been conducted for different populations. However, no reliability study of the handheld dynamometer device in patients with AIS has been found in the literature. Therefore, the aim of our study is to study the intra-rater and inter-rater reliability and validity of the trunk flexion, extension and lateral flexion muscle strengths of the hand dynamometer device in cases with AIS, which are known to have changes in muscle strength compared to their peers as a result of the change in spinal alignment. After obtaining the demographic information of the cases that meet the inclusion criteria within the scope of the study, the isometric muscle strength of the trunk flexor, extensor and right-left lateral flexor muscles will be evaluated by two different evaluators using a Lafayette hand dynamometer. To avoid systematic error, each participant will perform the isometric handheld dynamometer protocol in a random testing order. In order to determine interobserver reliability, on the first day of the test, the same hand dynamometer protocol will be applied to each participant by two different evaluators, after a 1-hour rest to prevent fatigue. To determine intraobserver reliability and compliance, participants will be re-evaluated by the same researchers at the same protocol, place and day period, 1 week apart to prevent learning effects. This study will reveal the intraobserver and interobserver reliability and validity of the handheld dynamometer device, which can be used in the evaluation of trunk muscle strength for clinicians working with AIS.
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane, and is an important public health problem with a global prevalence of 0.47-5.2%. Muscle strength is an important factor in maintaining postural balance in AIS, and it is observed that both clinicians and researchers evaluate the muscle strength of cases with AIS using different objective devices. Objective muscle strength assessment methods include electromyography, hand dynamometry and isokinetic dynamometry. Electromyography devices and isokinetic dynamometers are expensive and their use in the clinic is limited because they are not easily portable. Therefore, it has been shown to be a valid and reliable method to evaluate trunk muscle strength in different populations and pathologies such as healthy adults, healthy athletic individuals, chronic low back pain or hemiplegic patients; The handheld dynamometer device, which has the advantage of being cheaper and more portable than other devices, appears as a suitable option for clinicians to evaluate trunk isometric muscle strength. No reliability studies of hand dynamometer devices have been found in the AIS population. Therefore, our aim in the study is to study the intra-observer and inter-observer reliability and validity of the trunk flexion, extension and lateral flexion muscle strengths of the hand dynamometer device in patients with AIS, who are known to have changes in muscle strength compared to their peers as a result of the change in spinal alignment. This study will reveal the validity of the hand dynamometer device that can be used in the evaluation of trunk muscle strength for clinicians working with AIS.
- Keywords
- Scoliosis, Rehabilitation, Exercise, Reliability
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intra-rater and inter-rater validity and reliability | Intra-rater and inter-rater validity and reliability of trunk flexion, extension and right-left lateral flexion isometric muscle strength in cases with AIS will be performed with the Lafeyette hand dynamometer device ((Lafayette Manual Muscle Testing System, Lafayette Instrument Co, Lafayette, Indiana). To avoid systematic error, each participant will perform the isometric handheld dynamometer protocol in a random testing order. In order to determine inter-rater reliability, the same hand dynamometer protocol will be applied to each participant by two different assessors on the first day of the test. Participants will be given a 1-hour rest period between evaluators to prevent fatigue in the evaluations to be held on the same day. To determine inter-rater reliability and agreement, participants will be re-evaluated by the same researchers, at the same protocol, place and day, with a 1-week interval to prevent learning effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric trunk flexor strength
Isometric trunk flexor strength, two different test positions were adapted based on current literature. The first position will be measured on the back at 0 degrees of extension, with the knees straight. The dynamometer will be placed below the suprasternal notch of the sternum. Participants will be instructed to place their hand on the opposite acromion. To prevent pelvic rotation, participants will be fixed with the help of a belt from the anterior superior iliac spine and 10 cm above the lateral malleolus. The second position will be measured on the back in a 30 degree flexion position with the knees straight. The dynamometer will be placed below the suprasternal notch of the sternum. Participants will be instructed to place their hand on the opposite acromion. To prevent pelvic rotation, participants will be fixed with the help of a belt from the anterior superior iliac spine and 10 cm above the lateral malleolus.
Measured: Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1)
Isometric trunk extension strength
Isometric trunk extension strength, two different test positions were adapted based on current literature. The first position will be measured face down in 0 degree extension position. The dynamometer will be placed at the height T4. Participants will be instructed to place their hands on their foreheads. Participants will be fixed with the help of a belt from the posterior superior iliac spine and 10 cm above the lateral malleolus to prevent pelvic rotation. The second position will be measured face down in a 30 degree flexion position. The dynamometer will be placed at the height T4. Participants will be instructed to place their hands on their foreheads. Participants will be fixed with the help of a belt from the posterior superior iliac spine and 10 cm above the lateral malleolus to prevent pelvic rotation.
Measured: Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1)
Isometric trunk lateral flexion strength
Isometric trunk lateral flexion strength will be measured in the sitting position. Participants will sit on a chair with their feet not touching the ground and their hips in 90° flexion, and the participant will be fixed with the help of a strap. The dynamometer will be placed at shoulder level. Participants will be instructed to place their hand on the opposite acromion. Trials in which excessive motion (a detectable amount of movement or rotation in the transverse plane) occurs will be rejected and measured as.
Measured: Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Kurt, Istanbul University - Cerrahpasa
- Investigators
- İrem Kurt Ulusoy, Principal investigator, Istanbul University - CerrahpasaElcin Akyurek, Principal investigator, Istanbul University - Cerrahpasaİpek Yeldan, Principal investigator, Istanbul University - CerrahpasaAyse Zengin Alpozgen, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416592
- Sponsor's protocol ID
- IUC5
- Status last verified
- Jun 2026
- First submitted
- 12 May 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No