An interventional study of Conventional Exercise Program and Whole-Body Vibration in Hypermobility Spectrum Disorder, sponsored by Gökalp Arif Utkugün. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Gökalp Arif Utkugün · Not applicable, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 58 interventional studies indexed under Joint Instability.
Browse Joint Instability studies →This is the only study on the registry with Gökalp Arif Utkugün as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Isometric Muscle Strength Measured With a Hand-Held Dynamometer
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.
Time frame: 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
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Pressure Pain Threshold
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Dominant-Side Handgrip Strength
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in 6-Minute Walk Distance
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
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Weight
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Fat Percentage
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Muscle Mass
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.
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Plan to share: No — Individual participant data will not be made publicly available in order to protect participant confidentiality.
Started Jul 2025 (actual). Primary completion is estimated for Oct 2026, 15 months after the start.
Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 15 months is close to that.
Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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