Whole-Body Vibration and Postural Stability in Painful HSD

NCT07830589 | Active Not Recruiting

• 1 other identifier: 2025.296.IRB2.137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate the effects of adding whole-body vibration training to a conventional exercise program on postural stability and pain in painful women with hypermobility spectrum disorder. Participants are randomly allocated to conventional exercise or conventional exercise plus whole-body vibration groups and complete a 6-week supervised intervention program.

Conditions

Hypermobility Spectrum Disorder

Keywords

Joint Hypermobility; Whole-Body Vibration; Postural Stability; Balance; Pain; exercise

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Mean Velocity of Postural Sway

  Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Mean velocity was automatically calculated by the APDM system and expressed in meters per second (m/sec). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway velocity.

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Path Length of Postural Sway

  Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Path length was automatically calculated by the APDM system and expressed in meters per second squared (m/sec²). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less postural sway. Change = post-intervention minus baseline; negative values indicate reduced path length.

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Sway Area

  Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Sway area was automatically calculated by the APDM system and expressed in square meters per second to the fourth power (m²/sec⁴). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway area.

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Normalized Reach Distance on the Star Excursion Balance Test

  Dynamic postural stability was assessed with the Star Excursion Balance Test (SEBT). Reach distance was measured in the anterior, posteromedial, and posterolateral directions on both lower limbs. Three trials were performed for each direction, and the mean was normalized to the corresponding limb length: (mean reach distance / limb length) × 100. Results were expressed as % of limb length. Six values were analyzed separately: right and left anterior, posteromedial, and posterolateral reach. This is a continuous distance-based measure, with a minimum of 0% and no fixed maximum. Higher values indicate better reach performance. Change = post-intervention minus baseline; positive values indicate improvement.

  Baseline and 3 to 10 days after completion of the 6-week intervention.

Secondary Outcomes (8)

• Change From Baseline in Isometric Muscle Strength Measured With a Hand-Held Dynamometer

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Average Pain Intensity Assessed With the Numeric Rating Scale

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Pressure Pain Threshold

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in Dominant-Side Handgrip Strength

  Baseline and 3 to 10 days after completion of the 6-week intervention.

• Change From Baseline in 6-Minute Walk Distance

  Baseline and 3 to 10 days after completion of the 6-week intervention.

Study Arms (2)

Conventional Exercise Group

ACTIVE COMPARATOR

Participants allocated to this arm received a supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician.

Other: Conventional Exercise Program

Conventional Exercise Plus Whole-Body Vibration Group

EXPERIMENTAL

Participants allocated to this arm received the same supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, with the addition of whole-body vibration exercises. The intervention was continued for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician.

Other: Conventional Exercise Program; Device: Whole-Body Vibration

Interventions

Conventional Exercise Program OTHER

A supervised exercise program consisting of proprioceptive, core stabilization, and resistance exercises was performed for six weeks. Exercises were progressively administered according to the study protocol under the supervision of a resident physician.

Conventional Exercise Group; Conventional Exercise Plus Whole-Body Vibration Group

Whole-Body Vibration DEVICE

Whole-body vibration exercises were performed using a Power Plate Pro5 vibration platform in addition to the conventional exercise program. The intervention was administered as part of the supervised six-week exercise program.

Also known as: Power Plate Pro5

Conventional Exercise Plus Whole-Body Vibration Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of hypermobility spectrum disorder (Beighton score ≥4/9)
• Female participants aged 18-45 years
• Presence of musculoskeletal pain for at least 3 months

You may not qualify if:

• Pregnancy
• Presence of a cardiac pacemaker, an implanted brain stimulator, a metal implant
• Acute or chronic arthritis
• Active malignancy
• Acute infection
• Initiation of medications that may affect proprioception or postural stability (e.g., antidepressants, antipsychotics, or hypnotics) within the previous 2 months
• Regular exercise more than 3 days per week
• Postmenopausal status
• Orthopedic surgery within the previous 12 months
• Vertigo
• Acute painful conditions that would prevent participation in exercise

Sponsors & Collaborators

• Gökalp Arif Utkugün: lead

Study Sites (1)

Koç University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Mittal N, Santa Mina D, Buryk-Iggers S, Lopez-Hernandez L, Hussey L, Franzese A, Katz J, Laflamme C, McGillis L, McLean L, Rachinsky M, Rozenberg D, Slepian M, Weinrib A, Clarke H. The GoodHope Exercise and Rehabilitation (GEAR) Program for People With Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders. Front Rehabil Sci. 2021 Nov 8;2:769792. doi: 10.3389/fresc.2021.769792. eCollection 2021.

  PMID: 36188836 BACKGROUND

• Ewertowska P, Formella O, Poniatowski L, Zielinska A, Krzysztofik M, Czaprowski D. Effect of whole-body vibration on postural stability in young adults with generalized joint hypermobility: A comparative study. J Back Musculoskelet Rehabil. 2024;37(5):1363-1371. doi: 10.3233/BMR-240004.

  PMID: 38607750 BACKGROUND

MeSH Terms

Conditions

Joint Instability; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gökalp Utkugün, MD

  Koc University Hospital

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: July 3, 2025
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)