An interventional study of Plantar Sensorial Training and Control Group in Hallux Valgus, Pain and Balance; Distorted, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
Among 11 studies in Hallux Valgus with a site in Turkey — 4 open to participants now, 4 under way, none of them phase 3. Hallux Valgus · Turkey.
Among the 11 studies in Hallux Valgus with a site in Turkey, this one is the only one that started in 2020, is one of 7 with no phase, and was the 1st registered.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
Browse Hallux Valgus studies →4 of the 11 studies in Hallux Valgus with a site in Turkey are open now. Recruiting first, the newest first:
Beylikduzu State Hospital · Sites in Turkey
Ages 60–80
Hacettepe University · Sites in Turkey
Ages 18–65
Bezmialem Vakif University · Sites in Turkey
Ages 18–55 · Healthy volunteers
SEFA HAKTAN HATIK · Sites in Turkey
Ages 18+ · Healthy volunteers
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 1 started in 2020.
This study's enrollment of 30 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Median enrollment 31 across the 7 interventional studies, 69 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 10 most frequent:
Hacettepe University is the lead sponsor of 1,009 studies on the registry; 214 are open to participants now.
Hacettepe University has 4 studies filed under Hallux Valgus — fewer than ten, so there is no comparison to draw.
1 of the studies in Hallux Valgus with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07409974Hacettepe UniversityImmediate Effect of Taping on Foot Biomechanics in Patients With Hallux Valgus | 2027-02-15 |
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Among the 11 studies in Hallux Valgus with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Hallux valgus is a forefoot deformity with a high prevalence, which can progress to lateral deviation of the big toe, medial deviation of the first metatarsal, and subluxation of the first metatarsophalangeal joint in the future. It has been reported in studies that changes in the load distribution of the foot in hallux valgus patients, hyperkeratosis, especially first-line pain, and sensory receptors on the sole of the foot may result in the effect of sensory receptors on the sole of the foot, and thus the balance may be negatively affected, poor postural stability and an increase in the risk of falling. It is thought that increased sensitivity to the senses coming from the feet with sensory training can improve the balance and reduce the risk of falling as a result of better perception of foot orientation and position.
Achieving balance depends on the visual, vestibular and somatosensory systems working together and in interaction. One of the important components of the somatosensory system is the cutaneous receptors. Merkel discs, Paccini corpuscles, Meissner corpuscles and Ruffini endings are located on the plantar surface of the foot, which makes contact with the ground. Plantar cutaneous receptors are sensitive to pressure during ground contact and provide site-specific information for cortical mapping and may affect postural responses. It is recommended that sensory training of the sole of the foot, rough insoles and transcutaneous electrical stimulation applications should be added to rehabilitation in order to increase the afferent sensory feedback from the sole of the foot in patients with multiple sclerosis, starting from the early stages of the disease. It has been reported in studies that the sensory input of different foot regions has an important role in the transition and timing of the stance and swing phase in gait. It has been suggested that cutaneous reflexes in the foot can provide functional locomotion and modulation of lower extremity flexor and extensor muscle activity. It has been reported in studies that changes in the load distribution of the foot in hallux valgus patients, hyperkeratosis, especially first-line pain, and sensory receptors on the sole of the foot may result in the effect of sensory receptors on the sole of the foot, and thus the balance may be negatively affected, poor postural stability and an increase in the risk of falling. It is thought that increased sensitivity to the senses coming from the feet with sensory training can improve the balance and reduce the risk of falling as a result of better perception of foot orientation and position. Therefore, the aim of our study; It was determined as the examination of the effect of plantar sensory training on pain, foot posture, functional activities, gait and balance parameters in individuals with hallux valgus.
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Exclusion Criteria:
In addition to hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint, sensory training (using deep plantar massage, brushing, dipping techniques) will be performed.
Other: Plantar Sensorial Training
Routine hallux valgus physiotherapy approaches such as: hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint.
Other: Control Group
In addition to the routine treatment, plantar sensorial training will be added.
Routine physiotherapy management of the Hallux valgus
Change in Foot-Related pain assessment
Visual Analogue Scale will be used to evaluate the pain severity of individuals. Participants will be asked to mark their pain at rest and activity on a horizontal line of 100 millimeters, with 100 indicating maximum pain and 0 indicating no pain.
Time frame: change from baseline pain severity at 6 weeks
Change in Light touch sensation
The light touch sense of the sole of the foot will be evaluated with the Semmes-Weinstein monofilament test. This test is widely used to evaluate light touch and pressure sense. The response to touch is tested with monofilaments of varying thickness and diameter, and the value that the patient feels is recorded.
Time frame: change from baseline light touch sensation at 6 weeks
Change in foot function
The AOFAS Hallux-Metatarsophalangeal-Interphalangeal Scale created by the American Foot and Ankle Foundation (AOFAS) will also be used to evaluate foot function. In this scale, which is a 100-point scoring system that evaluates pain, function, and alignment, 90-100 points are excellent, 75-89 points are good, 50-74 points are good, and less than 50 points indicate poor status.
Time frame: change from baseline foot function at 6 weeks
Change in lower extremity functional level
The Lower Extremity Functionality Scale (LEFS), which is used in individuals with lower extremity problems, will be used to classify the functional status of individuals. AEFS is a 5-point Likert scale consisting of 20 questions. High scores in this scale, which has been adapted to Turkish and whose scoring ranges from 0 to 80, represent a better functional situation
Time frame: change from baseline Lower extremity functional level at 6 weeks
Change in gait parameters
Individuals' gait will be assessed using the GAITRite® computerized walking path (CIR System INC. Clifton, NJ 07012). Data from the system, which has 18,432 sensors, is obtained by pressure-activated sensors at a rate of 60-120 Hz. In order to eliminate the learning effect, the subjects will be asked to walk at the pace they choose after three attempts are made. Rest breaks will be given between assessments and the average of three repetitions of the walk will be recorded
Time frame: change from baseline temporo-spatial gait parameters at 6 weeks
Change in balance
Stability limits of individuals will be evaluated with Bertec Balance Check Trainer. Participants will be asked to lie on this device in the front, back, right and left directions as far as they can go without losing their balance and without lifting the soles of their feet off the platform, and the measurement results will be recorded by the system. Also, Postural sway of individuals will be evaluated and recorded with the Bertec Balance Check Trainer. It will be evaluated in four different conditions: flat ground with eyes open, flat ground with eyes closed, soft ground with eyes open and soft ground with eyes closed. Individuals will be asked to stand upright for 10 seconds for each situation, and the results will be recorded in centimeters by the system (Force plate AM, Bertec, Columbus, OH).
Time frame: change from baseline postural sway and limits of stability at 6 weeks
Plan to share: No
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Ran from Oct 2020 to primary completion in Oct 2022, 24 months.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 24 months is close to that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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