NCT06981884

Brief Summary

The aim of this study is to examine the effectiveness of core stabilization exercises applied with motor imagery training on motor imagery skills, functional status, body awareness, dynamic balance, quality of life and anxiety level parameters in mothers with physically disabled children within a biopsychosocial framework and to determine whether motor imagery training given in addition to core stabilization training has an effect on these parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

May 15, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

May 7, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

MothersDisabled childMotor imageryCore stabilizationlumbar instability

Outcome Measures

Primary Outcomes (9)

  • Oswestry Disability Index

    The Oswestry Disability Index is a valid functional measure for assessing axial LBP. The Turkish validity and reliability study of the questionnaire was conducted by Yakut and colleagues in 2004 (Yakut et al., 2004). The questionnaire reveals the level of functional disability related to activities of daily living (ADL) such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life and travel. Each disability in ADL is scored between 0 and 5, with 0 indicating no pain and 5 indicating the worst pain imaginable. The scores are then added up and converted to a percentage of the maximum score of 50. The resulting percentage is used to measure the level of disability. The evaluation is made by taking into account the questions answered as follows. Scoring = (Patient's score / Possible maximum score) X 100

    8 weeks

  • Visual Analog Scale

    The Visual Analog Scale, a subjective assessment of pain intensity, consists of a 100 mm long line. Participants were asked to rate their back pain during activity using basic descriptions from 0 to 10, such as "no pain" and "worst imaginable pain." The participant placed a mark reflecting the pain intensity, and the distance from the left endpoint to the mark was measured in mm.

    8 weeks

  • Algometer

    Pressure pain thresholds (PPTs) are usually used to measure deep muscular tissue sensitivity in experimental and clinical studies. The PPT is defined as the amount of pressure over a given area in which a steadily increasing non-painful pressure stimulus turns into a painful pressure sensation. The "gold standard" for measuring pressure pain sensitivity is the electronic pressure algometer, which quantifies the application of mechanical pressure.The pressure was increased steadily at a rate of approximately 1 kg/s. The patient was informed to stop when pressure sensitivity turned into pain. Each assessment was repeated 3 times with 10 seconds between measurements, and the mean value of the measurements was recorded as the pressure pain threshold.The test was stopped as soon as the patient reported pain and the force applied was recorded. BASELINE®, Doloriometer was used for PPT assessment.

    8 weeks

  • McGill's core endurance tests

    McGill's core endurance tests: McGill's tests were Used to examine participants' core endurance. These tests consisted of four positions: the trunk anterior flexor test, the right and left lateral plank, and trunk posterior extensor test. Participants performed one practice trial that lasted a few seconds to confirm correct positioning and then one test trial was recorded per position where the maximum time (seconds) participants could maintain a static Position was measured. The same investigator visually determined the end of all tests to assure reliability of testing. This investigator used the commands 'start' and 'stop' to initiate and conclude the test while an assistant investigator recorded the times using a stopwatch. The order of the four test positions was randomly assigned.

    8 weeks

  • Modified Star Excursion Balance Test

    The Modified Star Excursion Balance Test is reliable methods commonly used to clinically assess dynamic balance of the lower extremity.The 8 directions in the Star Excursion Balance Test are arranged as 3 directions in the Modified Star Excursion Balance Test.The tape measures were fixed by sticking them to the floor so that the angle between the anterior and posterolateral and posteromedial directions was 135ᵒ; the angle between the posteromedial-posterolateral directions was 90ᵒ. Then, they were asked to reach 3 times for all directions and the average was taken. The test score was calculated with the formula \[Average reach distance (cm) / lower extremity length (cm) x 100\]

    8 weeks

  • Pressure Biofeedback

    A pressure biofeedback device (Chatanooga, Australia, 2005) was used to evaluate the activity of the TrA muscle. The pressure biofeedback device is a tool used in practice in the clinic to measure the pressure produced by the TrA muscle during activation, with an emphasis on segmental stabilization . Before the test, all participants were taught the abdominal wall pulling (abdominal hallowing) maneuver. The pressure biofeedback device was fixed at 70 mmHg. For the measurement of TrA muscle activity, the pressure biofeedback device was placed under the abdomen at the level of the anterior superior iliac spine while the patient was in a supine position. The participant was asked to perform the abdominal hallowing maneuver and continue the contraction for 10 seconds. The change in pressure was recorded, and the highest value from 3 trials was taken.

    8 weeks

  • Modified Schober Test

    alternatives. Learn more Participants' lumbar flexion flexibility was evaluated with the Modified Schober Test. The researcher physiotherapist placed both thumbs on the participant's posterior superior iliac spine and marked the midpoint of the distance between the two points. Then, 10 cm above and 5 cm below this point were determined and marked. After the researcher physiotherapist told the participant to bend forward as much as possible with their knees straight, he measured and recorded the new distance between the lower and upper limit points. The distance difference between the new measurements is used to indicate the amount of lumbar flexion. A difference of 0-5 cm indicates that lumbar flexion flexibility has decreased, while a difference of 10 cm or more indicates that lumbar flexion flexibility has increased. Values between 5-10 cm are considered normal.

    8 weeks

  • Movement Imagery Questionnaire-3

    Participants' motor imagery ability was assessed using the Movement Imagery Questionnaire-3.. The survey consists of 3 sub-dimensions: internal visual imagery, external visual imagery and kinesthetic imagery, and includes 12 tasks. Participants were asked to perform these tasks in the visual and kinesthetic imagery type. Each task was first explained, physically performed, then the participant returned to the starting position and imagery was performed according to the visual/kinesthetic imagery type. The participant rated the ease or difficulty of creating an imagery on a 7-point scale. In this scale, 1 means "very difficult to see/feel" and 7 means "very easy to see/feel". The actions performed included the upper extremity, lower extremity and body. When calculating the score, the scores of all sub-dimensions were added separately and averaged by dividing by 4. A higher score indicates better mental imagery ability.

    8 weeks

  • Body Awareness Questionnaire

    The Body Awareness Questionnaire is a scale that includes physical, emotional and social elements about a person's sensitivity to normal or abnormal body states and processes and questions their sensitivity to physical reactions.The questionnaire consists of four subscales. These are (1) estimation of body reactions, (2) sleep-wake cycle, (3) estimation of the onset of the disease, and (4) attention to changes and reactions in body processes. Participants were asked to score each of the 18 statements on a scale of 1 to 7 (1=Not true for me at all, 7=Very true for me). The maximum score that can be obtained from the questionnaire is 126, and the minimum score is 18. The higher the score, the better the level of body awareness.

    8 weeks

Secondary Outcomes (3)

  • SF-36

    8 weeks

  • Trait Anxiety Inventory.

    8 weeks

  • International Physical Activity Questionnaire - Short Form

    8 weeks

Study Arms (2)

core stabilization exercises group

ACTIVE COMPARATOR

Group 1: Core stabilization exercise group Participants will be given core stabilization exercises 2 days a week, 45 minutes per session, for 2 months. At the end of 2 months, the outcome measurements will be taken by an evaluator physiotherapist who is not present during the treatment.

Other: core stabilization exercises

motor imagery training group

EXPERIMENTAL

Group 2: Core stabilization exercise + motor imagery training group Participants will be given core stabilization exercises and motor imagery training 2 days a week, 60 minutes per session, for 2 months. At the end of 2 months, the outcome measurements will be taken by the same evaluator physiotherapist who is not present during the treatment.

Other: core stabilization exercisesOther: motor imagery training group

Interventions

Participants will be given core stabilization exercises 2 days a week, 45 minutes per session, for 2 months. At the end of 2 months, the outcome measurements will be taken by an evaluator physiotherapist who is not present during the treatment.

core stabilization exercises groupmotor imagery training group

core stabilization exercise + motor imagery training group Participants will be given core stabilization exercises and motor imagery training 2 days a week, 60 minutes per session, for 2 months. Motor imagery training will be applied for 15 minutes immediately after the core stabilization exercisesAt the end of 2 months, the outcome measurements will be taken by the same evaluator physiotherapist who is not present during the treatment

motor imagery training group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 18-65 (Mothers of physically disabled children)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The primary caregiver of the disabled child is the mother
  • The prone lumbar instability test is (+)
  • Not receiving any medical treatment for pain
  • Not having any obstacles to exercise
  • VAS ≥4 low back pain at baseline

You may not qualify if:

  • Pregnancy
  • History of previous back surgery in the last year
  • Having peripheral vascular diseases,radiculopathy, spondylolisthesis, tumor, systemic inflammatory diseases.
  • Having cognitive disorders.
  • Having central or peripheral neurological disease affecting mobility.
  • Having received physical therapy due to back pain in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman Fatih Kılınç Özel Eğitim ve Rehabilitasyon Merkezi

Batman, Merkez, 72000, Turkey (Türkiye)

Location

Related Publications (4)

  • Imamura M, Alfieri FM, Filippo TR, Battistella LR. Pressure pain thresholds in patients with chronic nonspecific low back pain. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):327-336. doi: 10.3233/BMR-150636.

    PMID: 26406214BACKGROUND
  • La Touche R, Grande-Alonso M, Cuenca-Martinez F, Gonzalez-Ferrero L, Suso-Marti L, Paris-Alemany A. Diminished Kinesthetic and Visual Motor Imagery Ability in Adults With Chronic Low Back Pain. PM R. 2019 Mar;11(3):227-235. doi: 10.1016/j.pmrj.2018.05.025. Epub 2019 Jan 15.

    PMID: 29908933BACKGROUND
  • Vrana A, Hotz-Boendermaker S, Stampfli P, Hanggi J, Seifritz E, Humphreys BK, Meier ML. Differential Neural Processing during Motor Imagery of Daily Activities in Chronic Low Back Pain Patients. PLoS One. 2015 Nov 16;10(11):e0142391. doi: 10.1371/journal.pone.0142391. eCollection 2015.

    PMID: 26569602BACKGROUND
  • Salik Sengul Y, Kaya N, Yalcinkaya G, Kirmizi M, Kalemci O. The effects of the addition of motor imagery to home exercises on pain, disability and psychosocial parameters in patients undergoing lumbar spinal surgery: A randomized controlled trial. Explore (NY). 2021 Jul-Aug;17(4):334-339. doi: 10.1016/j.explore.2020.02.001. Epub 2020 Feb 22.

    PMID: 32147444BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled single-blind study consisting of 2 groups: experimental and control. The control group received only core stabilization exercises, the experimental group received motor imagery training + core stabilization exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 21, 2025

Study Start

May 15, 2024

Primary Completion

May 20, 2025

Study Completion

June 5, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

no reason.

Locations