Hypermobility Spectrum Disorder
Conditions
Keywords
Joint Hypermobility, Whole-Body Vibration, Postural Stability, Balance, Pain, exercise
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.
Detailed description
Participants were randomly allocated to two groups. One group received a conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, while the other group received the same conventional exercise program combined with whole-body vibration exercises. Both groups participated in the exercise program for six weeks. All exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Participants were evaluated before and after the six-week intervention by a blinded outcome assessor who was unaware of the participants' group allocation.
Interventions
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.
DEVICEWhole-Body Vibration
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.
Sponsors
Gökalp Arif Utkugün
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of hypermobility spectrum disorder (Beighton score ≥4/9) * Female participants aged 18-45 years * Presence of musculoskeletal pain for at least 3 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Velocity of Postural Sway | Baseline and 3 to 10 days after completion of the 6-week intervention. | 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. |
| Change From Baseline in Path Length of Postural Sway | Baseline and 3 to 10 days after completion of the 6-week intervention. | 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. |
| Change From Baseline in Sway Area | Baseline and 3 to 10 days after completion of the 6-week intervention. | 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. |
| Change From Baseline in Normalized Reach Distance on the Star Excursion Balance Test | Baseline and 3 to 10 days after completion of the 6-week intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Isometric muscle strength was assessed on the dominant side using a Lafayette hand-held dynamometer. The anterior deltoid and quadriceps were evaluated separately. Three maximal isometric trials were performed for each muscle group, and the highest value was used for analysis. Strength was expressed in Newtons (N). Higher values indicate greater isometric muscle strength. Change from baseline was calculated as the post-intervention value minus the baseline value; positive values indicate increased strength. |
| 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. | Average pain intensity during the previous 2 weeks was assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10. A score of 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. Change from baseline was calculated as the post-intervention score minus the baseline score; negative values indicate a reduction in average pain intensity. |
| Change From Baseline in Pressure Pain Threshold | Baseline and 3 to 10 days after completion of the 6-week intervention. | Pressure pain threshold was assessed on the dominant side using a Wagner FDK20 pressure algometer at four sites: deltoid, trapezius, tibialis anterior, and the L3 paraspinal region. Three measurements were obtained at each site, and the mean of the final two was used for analysis. Results were expressed in kg/cm², and each site was analyzed separately. Higher values indicate a higher pressure pain threshold and lower mechanical pain sensitivity. Change = post-intervention minus baseline; positive values indicate increased pressure pain threshold. |
| Change From Baseline in Dominant-Side Handgrip Strength | Baseline and 3 to 10 days after completion of the 6-week intervention. | Handgrip strength of the dominant upper extremity was assessed using a Jamar digital hand dynamometer. Three maximal trials were performed, and the highest recorded value was used for analysis. Handgrip strength was expressed in kilogram-force (kgf). Higher values indicate greater handgrip strength. Change from baseline was calculated as the post-intervention value minus the baseline value; positive change values indicate increased handgrip strength. |
| Change From Baseline in 6-Minute Walk Distance | Baseline and 3 to 10 days after completion of the 6-week intervention. | Functional walking capacity was assessed using the 6-Minute Walk Test in a standardized 30-meter corridor. Participants were instructed to walk as far as possible during 6 minutes. The total distance walked was recorded in meters (m). Higher values indicate greater functional walking capacity. Change from baseline was calculated as the post-intervention distance minus the baseline distance; positive values indicate an increase in walking distance |
| Change From Baseline in Body Weight | Baseline and 3 to 10 days after completion of the 6-week intervention. | Body weight was measured using a body composition scale and recorded in kilograms (kg). Change from baseline was calculated as the post-intervention body weight minus the baseline body weight. |
| Change From Baseline in Body Fat Percentage | Baseline and 3 to 10 days after completion of the 6-week intervention. | Body fat percentage was estimated using a body composition scale and expressed as a percentage (%) of total body weight. Change from baseline was calculated as the post-intervention body fat percentage minus the baseline body fat percentage. |
| Change From Baseline in Muscle Mass | Baseline and 3 to 10 days after completion of the 6-week intervention. | Muscle mass was estimated using a body composition scale and recorded in kilograms (kg). Change from baseline was calculated as the post-intervention muscle mass minus the baseline muscle mass. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORGökalp Utkugün, MD
Koc University Hospital
Outcome results
None listed