NCT07483892

Brief Summary

This study investigates the effects of Pilates reformer exercise combined with cervical sensorimotor training using laser-guided visual feedback on balance performance. Participants were randomly assigned to three groups: a combined training group, a Pilates-only group, and a control group. Static and dynamic balance were assessed before and after the intervention. This study was registered retrospectively on ClinicalTrials.gov after participant enrollment had begun. Institutional Review Board (IRB) approval was obtained prior to participant enrollment.

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 Sep 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

cervical joint position sensesensorimotor trainingPilates exercisevisual feedbackbalance

Outcome Measures

Primary Outcomes (3)

  • Title: Dynamic balance - COP medio-lateral excursion rate(COP ML Rate) during gait stance phase

    Dynamic postural control assessed as the COP medio-lateral rate during gait (COP medio-lateral distance (mm)/foot width (mm)x100); higher percentages indicate greater COP curvature, reflecting a more normal foot rollover pattern. Unit of Measure: percent (%)

    Baseline and 12 weeks

  • Dynamic balance - COP Sway Rate during gait stance phase

    Dynamic postural control assessed as COP Sway Rate during gait (Net Sway Length/COP Path Length × 100); values closer to 0% indicate better dynamic balance. Unit of Measure: percent (%)

    Baseline and 12 weeks

  • Dynamic balance - Y-Balance Test (YBT) composite score

    Dynamic balance assessed using Y-Balance Test score (% of limb length); higher values indicate better dynamic balance. Unit of Measure: percent (%)

    Baseline and 12 weeks

Secondary Outcomes (4)

  • Title: Static balance - COP Sway Distance during quiet standing

    Baseline and 12 weeks

  • Static balance - COP ellipse area during quiet standing

    Baseline and 12 weeks

  • Cervical Joint Position Sense(CJPS) - Accuracy

    Baseline and 12 weeks

  • Cervical Joint Position Sense(CJPS) - Precision

    Baseline and 12 weeks

Other Outcomes (2)

  • Static posture balance - plantar pressure distribution across foot quadrants

    Baseline and 12 weeks

  • Rearfoot alignment - resting calcaneal stance position (RCSP)

    Baseline and 12 weeks

Study Arms (3)

Cervical Sensorimotor Training with Pilates Reformer Exercise

EXPERIMENTAL

Participants performed Pilates reformer exercise combined with cervical sensorimotor training using laser-guided visual feedback.

Behavioral: Cervical Sensorimotor TrainingBehavioral: Pilates Reformer Exercise

Pilates-only Exercise Group

ACTIVE COMPARATOR

Participants performed a Pilates reformer exercise program without cervical sensorimotor training.

Behavioral: Pilates Reformer Exercise

Control Group

NO INTERVENTION

Participants had no intervention

Interventions

Laser-guided cervical sensorimotor training designed to improve cervical joint position sense. Training included head repositioning tasks with visual feedback under progressively challenging postural conditions involving different base-of-support and surface stability levels.

Also known as: laser-guided visual-vestibular-cervical sensorimotor training
Cervical Sensorimotor Training with Pilates Reformer Exercise

Pilates Reformer-based exercise focusing on trunk stabilization, postural alignment, controlled balance using spring-based resistance and different base-of-support.

Cervical Sensorimotor Training with Pilates Reformer ExercisePilates-only Exercise Group

Eligibility Criteria

Age30 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female adults were included to reduce sex-related variability in balance and cervical proprioception measurements.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female adults aged 30-49 years
  • Individuals who use a computer for ≥6 hours per day
  • Individuals who have experienced musculoskeletal pain and discomfort (neck, shoulder, or lower back) within the past year
  • Individuals who voluntarily agreed to participate in the study
  • Individuals able to participate in exercise training

You may not qualify if:

  • History of musculoskeletal or neurological surgery within the past 6 months
  • Individuals diagnosed with severe fractures or neurological disorders requiring surgical treatment
  • Any severe condition affecting balance or gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University

Seoul, 03760, South Korea

Location

Related Publications (3)

  • Zarei, H., Norasteh, A. A., Rahmanpournashrudkoli, A. and Hajihoseini, E. (2020). The effects of Pilates training on static and dynamic balance of female deaf students: A randomized controlled trial. Journal of Bodywork and Movement Therapies, 24, 63-69.

    BACKGROUND
  • Wannaprom, N., Treleaven, J., Jull, G. and Uthaikhup, S. (2018). Neck muscle vibration produces diverse responses in balance and gait speed between individuals with and without neck pain. Musculoskeletal Science and Practice, 35, 25-29. https://doi.org/10.1016/j.msksp.2018.02.001

    BACKGROUND
  • Treleaven, J. (2017). Dizziness, unsteadiness, visual disturbances, and sensorimotor control in traumatic neck pain. Journal of Orthopaedic & Sports Physical Therapy, 47, 492-502. https://doi.org/10.2519/jospt.2017.7052

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This was an open-label study. Blinding was not feasible due to the nature of the exercise intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three groups: (1) Pilates exercise combined with sensory integration training, (2) Pilates exercise only, or (3) a control group with no exercise intervention. The intervention were conducted for a specified period, and gait parameters were measured as outcome variables to evaluate the effects of the interventions on gait characteristics.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 19, 2026

Study Start

September 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 10, 2021

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to privacy and ethical restrictions.

Locations