A Comparison of a Smart Orthosis Versus a Standard Orthosis in the Treatment of Hyperkyphosis and Balance Disorders in the Elderly

Design and Construction of New Spinal Orthosis with Vibratory Feedback Alert and Comparison of Its Efficacy versus Semi-Rigid Thoracolumbosacral Orthosis on Spinal Postural Alignment and Balance in Older Adults with Hyperkyphosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250606066092N2

Enrollment

Registered

2025-09-10

Start date

2025-09-13

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperkyphosis.

Interventions

Intervention 1: They used a novel spine orthosis with smart vibratory feedback. This orthosis consisted of a posture sensor and a vibrating motor in the scapular region, along with a soft lumbar suppo

Eligibility

Sex/Gender

All

Age

60 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged between 60 and 75 years Hyperkyphosis with a Cobb angle of 50 to 65 degrees Body Mass Index (BMI) between 23 and 30 kg/m² Ability to walk independently without any assistive devices Ability to stand unassisted for at least 2 minutes A score of 7 or higher on the Short Portable Mental Status Questionnaire (SPMSQ) A score of 4 or less on the 15-item Geriatric Depression Scale (GDS-15) No history of using a spinal orthosis in the past 6 months Current thoracic pain, rated between 3 and 7 on the Visual Analog Scale (VAS) at the time of assessment

Exclusion criteria

Exclusion criteria: Any neurological or muscular disease affecting test performance (e.g., neuropathic or myopathic conditions) Acute cardiovascular or pulmonary disease Any sensory-motor dysfunction Scoliosis exceeding 10 degrees Joint replacement in the lower limbs Severe hearing or visual impairments History of fracture or surgery in the spine or lower limbs within the past 12 months Neck pain at the time of assessment, rated greater than 3 on the Visual Analog Scale (VAS)

Design outcomes

Primary

Measure	Time frame
Kyphosis angle. Timepoint: Before the start of the intervention and after 6 weeks. Method of measurement: Kyphometer.	—

Secondary

Measure	Time frame
Spinal pain. Timepoint: Before intervention and after 6 weeks. Method of measurement: Visual Analog Scale.;Balance. Timepoint: Before intervention and after 6 weeks. Method of measurement: Berg balance test.;Trunk extensor muscle strength. Timepoint: Before intervention and after 6 weeks. Method of measurement: Dynamometer.;Fear of falling. Timepoint: Before intervention and after 6 weeks. Method of measurement: Falls Efficacy Scale.	—

Measure

Time frame

Spinal pain. Timepoint: Before intervention and after 6 weeks. Method of measurement: Visual Analog Scale.;Balance. Timepoint: Before intervention and after 6 weeks. Method of measurement: Berg balance test.;Trunk extensor muscle strength. Timepoint: Before intervention and after 6 weeks. Method of measurement: Dynamometer.;Fear of falling. Timepoint: Before intervention and after 6 weeks. Method of measurement: Falls Efficacy Scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Gasavi Nezhad

University of social welfare and rehabilitation sciences

gasavizeinab@gmail.com21 009822 18 00 10

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026