NCT07603609

Brief Summary

This randomized controlled study aims to investigate the effects of a sensorimotor training protocol using a mobilized balance platform device on proprioceptive system function, movement control, balance, physical performance, pain severity, and quality of life in patients with chronic low back pain. A total of 44 patients with chronic low back pain will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital. Participants will be randomly assigned to either a sensorimotor training group or a control group. The intervention group will receive sensorimotor training using the Huber 360 balance system, while the control group will perform a home exercise program including stretching, spinal mobility, lumbopelvic control, and balance exercises. Pain severity, proprioception, functional status, balance, physical performance, and quality of life will be assessed before and after treatment by an assessor blinded to group allocation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
6mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress9%
May 2026Nov 2026

First Submitted

Initial submission to the registry

May 3, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 3, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lumbar Proprioception Assessment

    Lumbar proprioception will be assessed using lumbar repositioning tests at 60 degrees flexion and 15 degrees extension. Participants will be asked to reproduce target lumbar positions, and the angular repositioning error will be recorded. Lower repositioning error values indicate better lumbar proprioceptive accuracy.

    Before treatment and immediately after completion of the 5-week intervention program

Secondary Outcomes (9)

  • Pain Severity Assessed by Visual Analog Scale

    Before treatment and immediately after completion of the 5-week intervention program

  • Functional Status Assessed by Oswestry Disability Index

    Before treatment and immediately after completion of the 5-week intervention program

  • Balance and Limits of Stability Assessed by Huber 360

    Before treatment and immediately after completion of the 5-week intervention program

  • Lumbar Flexion Range of Motion

    Before treatment and immediately after completion of the 5-week intervention program

  • Quality of Life Assessed by Short Form-36

    Before treatment and immediately after completion of the 5-week intervention program

  • +4 more secondary outcomes

Study Arms (2)

Home Exercise Program

ACTIVE COMPARATOR

Participants in this group will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises. The program will be performed for 30 minutes per session, twice weekly for 5 weeks.

Behavioral: Home Exercise Program

Huber 360 Sensorimotor Training

EXPERIMENTAL

Participants in this group will receive a sensorimotor training protocol using the Huber 360 balance system. The intervention will include progressive rotational and oscillatory exercises aimed at improving proprioception, balance, neuromuscular control, and movement control. Sessions will be performed for 30 minutes, twice weekly for 5 weeks.

Device: Huber 360 Sensorimotor TrainingBehavioral: Home Exercise Program

Interventions

Participants will receive sensorimotor training using the Huber 360 balance system. The protocol will include progressive rotational and oscillatory exercises designed to improve proprioception, balance, neuromuscular control, and movement control in patients with chronic low back pain. Sessions will be performed for 30 minutes, twice weekly for 5 weeks.

Huber 360 Sensorimotor Training

Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises. The program will be performed for 30 minutes per session, twice weekly for 5 weeks.

Home Exercise ProgramHuber 360 Sensorimotor Training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged between 18 and 55 years
  • Presence of chronic low back pain lasting at least 3 months
  • Pain intensity score of 3 or higher on the Visual Analog Scale (VAS)
  • Individuals with sufficient cognitive ability to understand and follow study procedures
  • Willingness to participate voluntarily in the study

You may not qualify if:

  • Participation in a similar training program within the last 12 months
  • History of lower extremity or spinal surgery
  • Presence of non-mechanical low back pain, inflammatory disease, or tumor
  • Uncontrolled hypertension or cardiac disease
  • History of malignancy
  • Presence of radicular symptoms associated with low back pain
  • Progressive neurological deficits
  • Neurogenic claudication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Gaziler physical therapy and rehabilitation hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sefa GÜMRÜK ASLAN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 22, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations