Pes PlanusNCT05296850
Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus
A study testing Manual Release and Kinesio Taping in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Pes planus is a postural deformity seen with decreased medial longitudinal arch (MLA) height and this causes intense stress on the plantar fascia. Pes planus may affect individuals' activities of daily living, their productivity in occupational environments, and the risk of injury and performance in sports; It has… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Manual Release and Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2022to 16 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who volunteer to participate in the study
- Individuals with bilateral pes planus
- Individuals who have not had any ankle injury in the last 6 months
Who cannot join
- Individuals with severe visual and hearing impairment
- Individuals with congenital shortness or deformity in their lower extremities
- Individuals who have had any lower extremity surgery
- Individuals with hallux valgus, hallux rigidus, or calcaneal epine
- Individuals with any musculoskeletal problem other than pes planus and systemic, neurological problems
- Individuals with chronic ankle instability
- Individuals who have had problems walking for the last 6 months
- Individuals who have received treatment for pes planus in the last 6 months and use insoles
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: Investigation of the Immediate Effects of Kinesio Taping and Manual Release on Lower Extremity Performance in Young Adults With Pes Planus
Pes planus is a postural deformity seen with decreased medial longitudinal arch (MLA) height and this causes intense stress on the plantar fascia. Pes planus may affect individuals' activities of daily living, their productivity in occupational environments, and the risk of injury and performance in sports; It has also been reported that it may cause different musculoskeletal diseases such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain in the future. Many clinical methods are used as a treatment for pes planus and most treatments involve supporting an overstretched plantar fascia and weakened MLA. The aim of the study is to investigate the immediate effects of kinesio taping and manual release on lower extremity performance in young adults with pes planus.
Read the detailed description
This study is a randomized controlled trial, will be carried out on volunteer individuals with pes planus aged between 18-25, studying at Ankara Yıldırım Beyazıt University. Evaluation of parameters and inclusion criteria, kinesio taping and manual release applications will be made by the Physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, Group 1 [Manual Release (MR)] and Group 2 [Kinesio Taping (KT)]. A simple randomization method will be used with opaque sealed envelopes containing "1" or "2". Group allocation will be performed by an independent therapist, not involved in the study. All individuals will be evaluated with timed up-and-go test, heel rise test, 10-meter walking test, and functional reach test before and after the intervention. Manual release will be applied to group 1 after the evaluation and the evaluations will be repeated immediately the end of the application. Kinesio taping will be applied to group 2 after the evaluation and the evaluations will be repeated 45 minutes after the end of the application.
- Conditions
- Pes Planus
- Being tested
- Manual Release, Kinesio Taping
- Keywords
- Pes planus, Kinesio Taping, Manual release, Plantar fascia
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ReleaseOther
Individuals are placed in the prone position with their knees extended. The calcaneus is kept in eversion while maintaining talocrural dorsiflexion. As the toes are stretched in dorsiflexion, the therapist slides the big toe distally and proximally along the plantar fascia and flexor hallucis longus. Soft tissue mobilization depth will be applied according to the patient's tolerance and reactivity.
Kinesio TapingOther
In the first technique, an "I" tape will be applied on the plantar surface of the foot from the metatarsal heads to the popliteal fossa. First, the middle of the band is attached to the inferior of the calcaneus as the first anchor, then the ankle is dorsiflexed and the upper part of the band is applied with 15-25% tension until the popliteal fossa. The plantar fascia is placed in a stretched position by dorsiflexing the ankle and fingers, and the ends of the tape, which is divided into 4 parts, are applied separately to the metatarsal heads with 75-100% tension. In the second technique, the application is made with an "I" tape. The initial anchor starts from the dorsal aspect of the 5th metatarsal on the lateral aspect of the foot. Then, the tape passes to the medial side of the foot with 75-100% tension and is adhered to the medial side of the foot and ankle over the navicular. The end anchor is applied without tension.
| Study group | Role | What they receive |
|---|---|---|
| Manual release group | Experimental | Manual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes. Receives: Other: Manual Release |
| Kinesio taping group | Experimental | Two techniques will be used in kinesio taping application; first technique is the gastrocnemius muscle inhibition technique and the plantar fascia ligament correction technique and other technique is the transverse arch ligament correction technique. Receives: Other: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test (TUG)
The timed up and go test is used to assess functional mobility. The test involves getting up from a standard chair without armrests, walking around a cone 3 m in front of the chair, and returning to the original sitting position as quickly as possible without running. The test is started with the researcher's verbal "go" instruction and the time to complete the test is recorded. After a familiarization attempt, three recorded exercises are performed with one-minute rest intervals. The fastest of three attempts is saved.
Measured: Change from baseline at immediately after one-session treatment
Secondary outcomes (4)
Heel rise test (HRT)
The endurance of the gastro-soleus muscle complex is evaluated with the heel rise test. The number of toe-ups in one minute is determined when the knees of the subjects are in extension. The results are recorded as the number of repetitions.
Measured: Change from baseline at immediately after one-session treatment
10 meter walk test, walking speed
Walking speed is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). Measurements are repeated 3 times and the average time is recorded in seconds.
Measured: Change from baseline at immediately after one-session treatment
10 meter walk test, cadence
Cadence is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). During the 10-meter walk, the number of steps is recorded.
Measured: Change from baseline at immediately after one-session treatment
Functional reach test (FUT)
Balance is assessed with the functional reach test. In the application of the test, the individual is asked to keep his feet open and close to a parallel shoulder-width wall. The individual have a measuring stick attached to the wall at shoulder level. The individual is asked to punch his hand and flex his shoulder 90 degrees without touching the wall, and bring the third metacarpal finger joint of his hand to the starting point of the measuring stick.The individual is guided to reach as far as possible without taking a step, without lifting his heels, without bending his knees, and the end point is recorded. The difference between the starting position and the ending position is measured in cm. The test is repeated three times and the average of the three measurements is recorded.
Measured: Change from baseline at immediately after one-session treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start16 Feb 2022
- Primary completion16 Apr 2022 (estimated)
- Study completion16 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial: Two parallel treatment groups; participants were randomly allocated to Group 1 \[Manual release (MR)\] and Group 2 \[Kinesio taping (KT)\]
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
- Investigators
- Tuğba Ulusoy, PT, Principal investigator, Ankara Yildirim Beyazıt UniversityErtuğrul Demirdel, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296850
- Sponsor's protocol ID
- 2021-512
- Status last verified
- Apr 2022
- First submitted
- 7 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govind, S., Singh, K., Mahalingam, K. ve SREE Vamsi, G. To Compare the Effectiveness of Taping and Arch Support on the Flexible Flat Foot on a Random Population. Indian Journal of Forensic Medicine and Toxicology. 2020
Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.
PubMed 31590069Tas S, Unluer NO, Korkusuz F. Morphological and mechanical properties of plantar fascia and intrinsic foot muscles in individuals with and without flat foot. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018802482. doi: 10.1177/2309499018802482.
PubMed 30270752Angin S, Mickle KJ, Nester CJ. Contributions of foot muscles and plantar fascia morphology to foot posture. Gait Posture. 2018 Mar;61:238-242. doi: 10.1016/j.gaitpost.2018.01.022. Epub 2018 Mar 20.
PubMed 29413791Filardi V. Flatfoot and normal foot a comparative analysis of the stress shielding. J Orthop. 2018 Aug 16;15(3):820-825. doi: 10.1016/j.jor.2018.08.002. eCollection 2018 Sep.
PubMed 30140126Wang JS, Um GM, Choi JH. Immediate effects of kinematic taping on lower extremity muscle tone and stiffness in flexible flat feet. J Phys Ther Sci. 2016 Apr;28(4):1339-42. doi: 10.1589/jpts.28.1339. Epub 2016 Apr 28.
PubMed 27190479Montgomery G, McPhee J, Paasuke M, Sipila S, Maier AB, Hogrel JY, Degens H. Determinants of Performance in the Timed Up-and-Go and Six-Minute Walk Tests in Young and Old Healthy Adults. J Clin Med. 2020 May 21;9(5):1561. doi: 10.3390/jcm9051561.
PubMed 32455757Gunay S, Karaduman A, Ozturk BB. Effects of Aircast brace and elastic bandage on physical performance of athletes after ankle injuries. Acta Orthop Traumatol Turc. 2014;48(1):10-6. doi: 10.3944/AOTT.2014.2981.
PubMed 24643094Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.
PubMed 33986307Tedla JS, Asiri F, Alshahrani MS, Sangadala DR, Gular K, Rengaramanujam K, Mukherjee D. Reference Values of Functional and Lateral Reach Test Among the Young Saudi Population: Their Psychometric Properties and Correlation with Anthropometric Parameters. Med Sci Monit. 2019 Jul 31;25:5683-5689. doi: 10.12659/MSM.916443.
PubMed 31365521Baltacı, G. Bantlama. (N. Ozunlu Pekyavas, Ed.). Ankara: Hipokrat Yayıncılık.2020; 194-195
Cleland JA, Abbott JH, Kidd MO, Stockwell S, Cheney S, Gerrard DF, Flynn TW. Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2009 Aug;39(8):573-85. doi: 10.2519/jospt.2009.3036.
PubMed 19687575
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Immediate Effects of Kinesio Taping and Manual Release on Lower Extremity Performance in Young Adults With Pes Planus
- ClinicalTrials.gov ID
- NCT05296850
- Acronym / sponsor ID
- 2021-512
- Conditions
- Pes Planus
- Keywords
- Pes planus, Kinesio Taping, Manual release, Plantar fascia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 16 Apr 2022 (estimated)
- Study completion
- 16 Apr 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pes planus is a postural deformity seen with decreased medial longitudinal arch (MLA) height and this causes intense stress on the plantar fascia. Pes planus may affect individuals' activities of daily living, their productivity in occupational environments, and the risk of injury and performance in sports; It has also been reported that it may cause different musculoskeletal diseases such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain in the future. Many clinical methods are used as a treatment for pes planus and most treatments involve supporting an overstretched plantar fascia and weakened MLA. The aim of the study is to investigate the immediate effects of kinesio taping and manual release on lower extremity performance in young adults with pes planus.
Detailed description
This study is a randomized controlled trial, will be carried out on volunteer individuals with pes planus aged between 18-25, studying at Ankara Yıldırım Beyazıt University. Evaluation of parameters and inclusion criteria, kinesio taping and manual release applications will be made by the Physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, Group 1 [Manual Release (MR)] and Group 2 [Kinesio Taping (KT)]. A simple randomization method will be used with opaque sealed envelopes containing "1" or "2". Group allocation will be performed by an independent therapist, not involved in the study. All individuals will be evaluated with timed up-and-go test, heel rise test, 10-meter walking test, and functional reach test before and after the intervention. Manual release will be applied to group 1 after the evaluation and the evaluations will be repeated immediately the end of the application. Kinesio taping will be applied to group 2 after the evaluation and the evaluations will be repeated 45 minutes after the end of the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial: Two parallel treatment groups; participants were randomly allocated to Group 1 [Manual release (MR)] and Group 2 [Kinesio taping (KT)]
| Arm | Type | Receives |
|---|---|---|
| Manual release group | Experimental | Other: Manual ReleaseManual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes. |
| Kinesio taping group | Experimental | Other: Kinesio TapingTwo techniques will be used in kinesio taping application; first technique is the gastrocnemius muscle inhibition technique and the plantar fascia ligament correction technique and other technique is the transverse arch ligament correction technique. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals who volunteer to participate in the study
- Individuals with bilateral pes planus
- Individuals who have not had any ankle injury in the last 6 months
Key exclusion criteria (8 listed)
- Individuals with severe visual and hearing impairment
- Individuals with congenital shortness or deformity in their lower extremities
- Individuals who have had any lower extremity surgery
- Individuals with hallux valgus, hallux rigidus, or calcaneal epine
- Individuals with any musculoskeletal problem other than pes planus and systemic, neurological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual ReleaseIndividuals are placed in the prone position with their knees extended. The calcaneus is kept in eversion while maintaining talocrural dorsiflexion. As the toes are stretched in dorsiflexion, the therapist slides the big toe distally and proximally along the plantar fascia and flexor hallucis longus. Soft tissue mobilization depth will be applied according to the patient's tolerance and reactivity. | Other | Manual release group |
| Kinesio TapingIn the first technique, an "I" tape will be applied on the plantar surface of the foot from the metatarsal heads to the popliteal fossa. First, the middle of the band is attached to the inferior of the calcaneus as the first anchor, then the ankle is dorsiflexed and the upper part of the band is applied with 15-25% tension until the popliteal fossa. The plantar fascia is placed in a stretched position by dorsiflexing the ankle and fingers, and the ends of the tape, which is divided into 4 parts, are applied separately to the metatarsal heads with 75-100% tension. In the second technique, the application is made with an "I" tape. The initial anchor starts from the dorsal aspect of the 5th metatarsal on the lateral aspect of the foot. Then, the tape passes to the medial side of the foot with 75-100% tension and is adhered to the medial side of the foot and ankle over the navicular. The end anchor is applied without tension. | Other | Kinesio taping group |
Primary outcome
Timed up and go test (TUG)
Time frame: Change from baseline at immediately after one-session treatment
The timed up and go test is used to assess functional mobility. The test involves getting up from a standard chair without armrests, walking around a cone 3 m in front of the chair, and returning to the original sitting position as quickly as possible without running. The test is started with the researcher's verbal "go" instruction and the time to complete the test is recorded. After a familiarization attempt, three recorded exercises are performed with one-minute rest intervals. The fastest of three attempts is saved.
4 secondary outcomes
Heel rise test (HRT)
Time frame: Change from baseline at immediately after one-session treatment
10 meter walk test, walking speed
Time frame: Change from baseline at immediately after one-session treatment
10 meter walk test, cadence
Time frame: Change from baseline at immediately after one-session treatment
Functional reach test (FUT)
Time frame: Change from baseline at immediately after one-session treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- BackgroundGovind, S., Singh, K., Mahalingam, K. ve SREE Vamsi, G. To Compare the Effectiveness of Taping and Arch Support on the Flexible Flat Foot on a Random Population. Indian Journal of Forensic Medicine and Toxicology. 2020
- Background: PubMed 31590069Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.
- Background: PubMed 30270752Tas S, Unluer NO, Korkusuz F. Morphological and mechanical properties of plantar fascia and intrinsic foot muscles in individuals with and without flat foot. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018802482. doi: 10.1177/2309499018802482.
- Background: PubMed 29413791Angin S, Mickle KJ, Nester CJ. Contributions of foot muscles and plantar fascia morphology to foot posture. Gait Posture. 2018 Mar;61:238-242. doi: 10.1016/j.gaitpost.2018.01.022. Epub 2018 Mar 20.
- Background: PubMed 30140126Filardi V. Flatfoot and normal foot a comparative analysis of the stress shielding. J Orthop. 2018 Aug 16;15(3):820-825. doi: 10.1016/j.jor.2018.08.002. eCollection 2018 Sep.
- Background: PubMed 27190479Wang JS, Um GM, Choi JH. Immediate effects of kinematic taping on lower extremity muscle tone and stiffness in flexible flat feet. J Phys Ther Sci. 2016 Apr;28(4):1339-42. doi: 10.1589/jpts.28.1339. Epub 2016 Apr 28.
- Background: PubMed 32455757Montgomery G, McPhee J, Paasuke M, Sipila S, Maier AB, Hogrel JY, Degens H. Determinants of Performance in the Timed Up-and-Go and Six-Minute Walk Tests in Young and Old Healthy Adults. J Clin Med. 2020 May 21;9(5):1561. doi: 10.3390/jcm9051561.
- Background: PubMed 24643094Gunay S, Karaduman A, Ozturk BB. Effects of Aircast brace and elastic bandage on physical performance of athletes after ankle injuries. Acta Orthop Traumatol Turc. 2014;48(1):10-6. doi: 10.3944/AOTT.2014.2981.
- Background: PubMed 33986307Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.
- Background: PubMed 31365521Tedla JS, Asiri F, Alshahrani MS, Sangadala DR, Gular K, Rengaramanujam K, Mukherjee D. Reference Values of Functional and Lateral Reach Test Among the Young Saudi Population: Their Psychometric Properties and Correlation with Anthropometric Parameters. Med Sci Monit. 2019 Jul 31;25:5683-5689. doi: 10.12659/MSM.916443.
- BackgroundBaltacı, G. Bantlama. (N. Ozunlu Pekyavas, Ed.). Ankara: Hipokrat Yayıncılık.2020; 194-195
- Background: PubMed 19687575Cleland JA, Abbott JH, Kidd MO, Stockwell S, Cheney S, Gerrard DF, Flynn TW. Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2009 Aug;39(8):573-85. doi: 10.2519/jospt.2009.3036.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Ulusoy, PT principal investigator
Ankara Yildirim Beyazıt University
Ertuğrul Demirdel, PhD principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Release and Kinesio Taping in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (TUG) (time frame: Change from baseline at immediately after one-session treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296850, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.