Dorsiflexion Deformity of FootNCT05814029
Different Mobilization Techniques on Balance, Gait, Jumping and Foot Plantar Pressure
A study testing Mobilization with movement for Ankle in people with Dorsiflexion Deformity of Foot, run by Muhammet Ayhan ORAL at 1 site in Turkey (Türkiye).
Trial summary
Adequate ankle dorsiflexion range of motion is important for normal performance of functional activities such as walking, running and climbing stairs. It is important to gain the ankle dorsiflexion range of motion, which affects the functional activities and sports associated with squats and lunges. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dorsiflexion Deformity of Foot
- What is being tested?
- Mobilization with movement for Ankle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 1 Mar 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35
- Volunteering to participate in the study
- Active Dorsiflexion range of motion is below 45˚
Who cannot join
- Having a history of ankle pain and injury in the last 6 months
- Having a Neurological, Rheumatological or Systemic disease
- Having had any lower extremity surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Mobilization Techniques on Balance, Gait, Jumping and Foot Plantar Pressure in Individuals With Ankle Dorsiflexion Limitation
Adequate ankle dorsiflexion range of motion is important for normal performance of functional activities such as walking, running and climbing stairs. It is important to gain the ankle dorsiflexion range of motion, which affects the functional activities and sports associated with squats and lunges. Stretching and manual therapy are the most frequently used applications to gain range of motion. Manual therapy has been proposed as a possible treatment to improve mobility and restore arthrokinematics of joints. Movement mobilization, which is a manual therapy method, is an active joint mobilization concept. Talocrural mobilization with the movement technique is an extension of traditional joint mobilizations and allows the patient to engage in therapy in an active, partial weight-bearing lunge position. There are variations of this technique that can be applied by the clinician or by the individual himself. Our aim in this study is to compare the effects of movement and mobilization applications, which can be applied by the clinician or by the individual himself, on balance, gait, jumping and plantar pressure. Healthy asymptomatic individuals between the ages of 18-35 whose active ankle dorsiflexion range of motion as measured by the weight-bearing lunge test in the dominant extremity is below 45˚ will be included in the study. According to the inclusion criteria, the individuals to be included in the study will be randomly divided into three groups. Mobilization technique by the clinician will be applied to one group, and the mobilization technique by the individual himself will be applied to another group. The third group will be the control group. Evaluations will be made before and after mobilization applications. Balance will be evaluated with Y balance test, gait and jump will be evaluated with G-Walk, and plantar pressure will be evaluated with pedobarography device.
Read the detailed description
Adequate ankle dorsiflexion range of motion is required for normal performance of functional activities such as walking, running, and climbing stairs. Limited ankle dorsiflexion is a common ankle movement disorder that affects squat and lunge-related functional activities and sports. Soft tissue, myofascial tension or muscle tension in the ankle and foot have been identified as the main etiologic factors causing limited ankle dorsiflexion in asymptomatic populations. Limited dorsiflexion range of motion has been associated with genu recurvatum, excessive subtalar joint pronation, ankle sprains, medial tibial stress syndrome, Achilles tendinopathy, plantar fasciitis, anterior knee pain, gastrocnemius strains, and anterior cruciate ligament injuries. Therefore, gaining ankle dorsiflexion range of motion seems to be an important goal in the treatment of lower extremity injuries. Manual therapy has been proposed as a possible treatment to improve mobility and restore arthrokinematics of joints. Movement mobilization is the concept of active joint mobilization. The aim is to render painful movement disorder painless and allow the patient to engage in normal functional activity in the progressive recovery process. Talocrural mobilization with the movement technique is an extension of traditional joint mobilizations and allows the patient to engage in therapy in an active, partial weight-bearing lunge position. There are variations of this technique that can be applied by the clinician or by the individual himself. There are studies showing the effect of clinician-applied motion mobilization on range of motion, static balance, gait, and plantar pressure in different populations. In a study conducted by Reid et al. in individuals with ankle sprains, they observed an increase in ankle dorsiflexion joint range of motion immediately after mobilization with motion for the talocrural joint. In their study, Vicenzino et al. demonstrated the curative effect of motion mobilization techniques on posterior talar shift and dorsiflexion range of motion in individuals with recurrent lateral ankle sprains. Based on this result, they stated that this technique should be considered in rehabilitation programs after lateral ankle sprain. Tomruk et al. showed that the application of the motion mobilization technique to the ankle joint significantly improved postural control in the anteroposterior direction compared to the sham group in healthy individuals. However, overall postural control and dorsiflexion range of motion were significantly increased in both groups compared with initial measurements. On the other hand, the stability limit reaction time was significantly shortened in the motion-only group. In their study, Marrón-Gómez et al. stated that the application of motion mobilization technique and manipulation of the talocrural joint significantly improved ankle dorsiflexion in participants with chronic ankle instability. No significant difference was found between these two techniques, but the results of the application of the motion mobilization technique before the application and the evaluation two days after the application showed larger in-group effect sizes than the high speed and low intensity talocrural joint manipulation. When both treatments were compared with the placebo group, both active interventions were more effective in improving dorsiflexion with larger effect sizes. Yoon et al. reported that passive ankle dorsiflexion improved range of motion, heel-rise time, and dynamic plantar loading during 5-minute walking with a modified motion mobilization technique using talus gliding taping in individuals with limited ankle dorsiflexion. An and Won found that motion ankle mobilization was more effective than simple weight bearing in improving walking speed in stroke patients with limited ankle motion. Gilbreath et al., in their study, showed that there was no significant change in weight-bearing dorsiflexion joint range of motion, in any aspect of the Star Excursion Balance Test, or in Foot and Ankle Ability Measurement-Activities of Daily Living scores after three sessions of motion mobilization technique in individuals with chronic ankle instability. . Although there was no significant change in these parameters, they found a significant improvement in Foot and Ankle Ability Measurement-Sports-Related Activities scores after intervention. Despite these studies investigating the effectiveness of movement mobilization applied by the clinician in different pathologies, there is only one study in the literature comparing the movement applied by the clinician and the individual and the mobilization technique. Stanek and Pieczynski, in their study in healthy individuals with dorsiflexion limitation, stated that both the clinician-applied mobilization and self-mobilization showed significant and sudden increases in the active weight-bearing dorsiflexion joint range of motion when compared to the control group, both while kneeling and standing. They found no significant difference between the groups to which the technique was applied. Based on the findings of this study, clinicians can prescribe self-administered mobilization technique to their patients and expect similar results to clinician-administered mobilization. However, only active dorsiflexion range of motion was evaluated in this study. Although there are studies showing the effect of the movement mobilization technique applied by the clinician on the active dorsiflexion range of motion, foot plantar pressure, jumping and balance, no study has been found in the literature comparing the movements applied by the clinician and the individual in terms of foot plantar pressure, jumping and dynamic balance. Therefore, the aim of this study is to compare the effects of these two techniques in terms of active dorsiflexion range of motion, plantar pressure, jump and dynamic balance in individuals with limited dorsiflexion range of motion.
- Conditions
- Dorsiflexion Deformity of Foot
- Being tested
- Mobilization with movement for Ankle
- Keywords
- Ankle mobility, Dorsiflexion Limitation, Mobilization with movement, Manuel Therapy, Plantar pressure, Balance, Gait, Jumping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movement for AnkleOther
The participant will assume a lunge position on a rigid serving table with the relevant extremity in a weight-bearing stance and the foot in a neutral position. An inelastic belt will be placed around the clinician's waist, flush with the lower edge of the medial malleolus, around the distal tibia and fibula. The clinician will stabilize the talus and forefoot with the web spacing of the hands and pressure dimensions on the talus and forefoot, and maintain posterior to anterior sliding of the tibia over the talus using the arch. The clinician will continue to apply pressure while the person is reporting discomfort and/or while the lunge moves, which will continue until the end of the range of motion. Mobilization will be performed as a 3 set of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| The group which mobilization with movement technique applied by clinician | Experimental | 17 individuals in this group, after evaluations, mobilization with movement technique applied by clinician and after that same evaluations will be applied Receives: Other: Mobilization with movement for Ankle |
| The group which mobilization with movement technique applied by individual himself | Experimental | 17 individuals in this group, after evaluations, mobilization with movement technique applied by individual himself and after that same evaluations will be applied Receives: Other: Mobilization with movement for Ankle |
| Control Group | No intervention | 16 individuals in this control group, Relevant Extremity will assume a lunge position on a firm mattress with the foot in a weight-bearing stance and the foot in a neutral position. The person will feel uncomfortable and/or the parts will suddenly lunge until the end of their range of motion. No mobilization technique will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active dorsiflexion range of motion (Degree)
Active dorsiflexion range of motion will be evaluated with the Weight Bearing Lunge test. The Weight Bearing Lunge test will be performed using a digital inclinometer. The inclinometer will be placed 15 cm below the anterior part of the tibia and the maximum tibial inclination will be measured while the participant is standing, knee flexed, while transferring weight without lifting the heel off the ground.
Measured: 2 Minutes
Balance (Centimeter)
Y balance test will be used to evaluate the dynamic balance. Participants will be asked to stand barefoot on the weight-bearing platform with their toes positioned back. Then, the participants will be asked to reach anteriorly (ANT), posteromedially (PM), and posterolaterally (PL) three times with their non-weight-bearing extremity.
Measured: 10 Minutes
Gait (second, meter)
Gait analysis will be evaluation with BTS G-WALK device. The G-walk will be placed on the Lumbal 5 level of each participant with the help of a belt. Participants will be asked to walk 8 m at their normal walking speed, turn, and return to their starting point. In this process, the spatiotemporal parameters of the gait will be evaluated.
Measured: 2 Minutes
Jumping (Centimeter)
Jumping performance will be evaluation with BTS G-WALK device. For evaluation, participants will keep their hands on their hips. Three attempts will be made before proceeding to the test. Individuals will be asked to reach the highest possible vertical length with each jump on the dominant leg. Three attempts will be recorded and the average of the jump height and anaerobic performance values for analysis.
Measured: 3 Minutes
Foot Plantar Pressure (centimeter2, contact area %)
Foot plantar pressure will be evaluated using a pedobarographic device. For the measurement, the participants will be asked to stand on the pedobarographic device in a fixed position with bare feet and feet at shoulder level. Participants will be instructed to look across at a fixed point with arms relaxed at both sides. Within the plantar pressure analysis measurements; in static conditions, percentage of contact (%), maximal pressure (N/cm²) and contact area for the dominant foot (cm²), contact surface (%), loads on the fore and hind feet (%) will be determined and recorded.
Measured: 3 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start30 Nov 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dorsiflexion Deformity of FootStudies of the same condition, open and under way.
- 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
- There will be three separate groups in the study. The individuals in the group will be completely different individuals. Each group will receive a different intervention. One of the groups will be the control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammet Ayhan ORAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammet Ayhan ORAL, Kırıkkale University
- Investigators
- Muhammed Yusuf DEMIRKAN, Bachelors, Study chair, Kırıkkale UniversityNevin GUZEL, Prof., Study chair, Gazi UniversityGamze COBANOGLU, Master, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814029
- Sponsor's protocol ID
- KU-MORAL-001
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
PubMed 24679362Hernandez-Guillen D, Roig-Casasus S, Tolsada-Velasco C, Garcia-Gomariz C, Blasco JM. Talus mobilization-based manual therapy is effective for restoring range of motion and enhancing balance in older adults with limited ankle mobility: A randomized controlled trial. Gait Posture. 2022 Mar;93:14-19. doi: 10.1016/j.gaitpost.2022.01.005. Epub 2022 Jan 10.
PubMed 35042057Brumitt J, Patterson C, Dudley R, Sorenson E, Hill G, Peterson C. COMPARISON of LOWER QUARTER Y-BALANCE TEST SCORES for FEMALE COLLEGIATE VOLLEYBALL PLAYERS BASED on COMPETITION LEVEL, POSITION, and STARTER STATUS. Int J Sports Phys Ther. 2019 Jun;14(3):415-423. doi: 10.26603/ijspt20190415.
PubMed 31681500Awotidebe TO, Ativie RN, Oke KI, Akindele MO, Adedoyin RA, Olaogun MO, Olubayode TE, Kolawole BA. Relationships among exercise capacity, dynamic balance and gait characteristics of Nigerian patients with type-2 diabetes: an indication for fall prevention. J Exerc Rehabil. 2016 Dec 31;12(6):581-588. doi: 10.12965/jer.1632706.353. eCollection 2016 Dec.
PubMed 28119881Yazici MV, Cobanoglu G, Yazici G. Test-retest reliability and minimal detectable change for measures of wearable gait analysis system (G-Walk) in children with cerebral palsy. Turk J Med Sci. 2022 Jun;52(3):658-666. doi: 10.55730/1300-0144.5358. Epub 2022 Jun 16.
PubMed 36326313Rodriguez-Rosell D, Mora-Custodio R, Franco-Marquez F, Yanez-Garcia JM, Gonzalez-Badillo JJ. Traditional vs. Sport-Specific Vertical Jump Tests: Reliability, Validity, and Relationship With the Legs Strength and Sprint Performance in Adult and Teen Soccer and Basketball Players. J Strength Cond Res. 2017 Jan;31(1):196-206. doi: 10.1519/JSC.0000000000001476.
PubMed 27172267Rabin A, Kozol Z, Spitzer E, Finestone AS. Weight-bearing ankle dorsiflexion range of motion-can side-to-side symmetry be assumed? J Athl Train. 2015 Jan;50(1):30-5. doi: 10.4085/1062-6050-49.3.40. Epub 2014 Oct 20.
PubMed 25329350Lee J, Park C, Cha Y, You JSH. Comparative effects of different manual techniques on electromyography activity, kinematics, and muscle force in limited ankle dorsiflexion syndrome. J Back Musculoskelet Rehabil. 2021;34(6):1105-1112. doi: 10.3233/BMR-200257.
PubMed 34057133Hernandez-Guillen D, Blasco JM. A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults. Phys Ther. 2020 Apr 17;100(4):645-652. doi: 10.1093/ptj/pzaa003.
PubMed 31944252Gogate N, Satpute K, Hall T. The effectiveness of mobilization with movement on pain, balance and function following acute and sub acute inversion ankle sprain - A randomized, placebo controlled trial. Phys Ther Sport. 2021 Mar;48:91-100. doi: 10.1016/j.ptsp.2020.12.016. Epub 2020 Dec 23.
PubMed 33401232An CM, Jo SO. Effects of Talocrural Mobilization with Movement on Ankle Strength, Mobility, and Weight-Bearing Ability in Hemiplegic Patients with Chronic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):169-176. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.005. Epub 2016 Oct 17.
PubMed 27765557Gilbreath JP, Gaven SL, Van Lunen L, Hoch MC. The effects of mobilization with movement on dorsiflexion range of motion, dynamic balance, and self-reported function in individuals with chronic ankle instability. Man Ther. 2014 Apr;19(2):152-7. doi: 10.1016/j.math.2013.10.001.
PubMed 24834500Tomruk M, Soysal Tomruk M, Alkan E, Gelecek N. Immediate Effects of Ankle Joint Mobilization With Movement on Postural Control, Range of Motion, and Muscle Strength in Healthy Individuals: A Randomized, Sham-Controlled Trial. J Sport Rehabil. 2020 Nov 1;29(8):1060-1068. doi: 10.1123/jsr.2019-0198. Epub 2019 Nov 19.
PubMed 31754078Vicenzino B, Branjerdporn M, Teys P, Jordan K. Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain. J Orthop Sports Phys Ther. 2006 Jul;36(7):464-71. doi: 10.2519/jospt.2006.2265.
PubMed 16881463Yoon JY, Hwang YI, An DH, Oh JS. Changes in kinetic, kinematic, and temporal parameters of walking in people with limited ankle dorsiflexion: pre-post application of modified mobilization with movement using talus glide taping. J Manipulative Physiol Ther. 2014 Jun;37(5):320-5. doi: 10.1016/j.jmpt.2014.01.007.
PubMed 24928640
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Mobilization Techniques on Balance, Gait, Jumping and Foot Plantar Pressure in Individuals With Ankle Dorsiflexion Limitation
- ClinicalTrials.gov ID
- NCT05814029
- Acronym / sponsor ID
- KU-MORAL-001
- Conditions
- Dorsiflexion Deformity of Foot
- Keywords
- Ankle mobility, Dorsiflexion Limitation, Mobilization with movement, Manuel Therapy, Plantar pressure, Balance, Gait, Jumping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Muhammet Ayhan ORALUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Apr 2023 (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.
Adequate ankle dorsiflexion range of motion is important for normal performance of functional activities such as walking, running and climbing stairs. It is important to gain the ankle dorsiflexion range of motion, which affects the functional activities and sports associated with squats and lunges. Stretching and manual therapy are the most frequently used applications to gain range of motion. Manual therapy has been proposed as a possible treatment to improve mobility and restore arthrokinematics of joints. Movement mobilization, which is a manual therapy method, is an active joint mobilization concept. Talocrural mobilization with the movement technique is an extension of traditional joint mobilizations and allows the patient to engage in therapy in an active, partial weight-bearing lunge position. There are variations of this technique that can be applied by the clinician or by the individual himself. Our aim in this study is to compare the effects of movement and mobilization applications, which can be applied by the clinician or by the individual himself, on balance, gait, jumping and plantar pressure. Healthy asymptomatic individuals between the ages of 18-35 whose active ankle dorsiflexion range of motion as measured by the weight-bearing lunge test in the dominant extremity is below 45˚ will be included in the study. According to the inclusion criteria, the individuals to be included in the study will be randomly divided into three groups. Mobilization technique by the clinician will be applied to one group, and the mobilization technique by the individual himself will be applied to another group. The third group will be the control group. Evaluations will be made before and after mobilization applications. Balance will be evaluated with Y balance test, gait and jump will be evaluated with G-Walk, and plantar pressure will be evaluated with pedobarography device.
Detailed description
Adequate ankle dorsiflexion range of motion is required for normal performance of functional activities such as walking, running, and climbing stairs. Limited ankle dorsiflexion is a common ankle movement disorder that affects squat and lunge-related functional activities and sports. Soft tissue, myofascial tension or muscle tension in the ankle and foot have been identified as the main etiologic factors causing limited ankle dorsiflexion in asymptomatic populations. Limited dorsiflexion range of motion has been associated with genu recurvatum, excessive subtalar joint pronation, ankle sprains, medial tibial stress syndrome, Achilles tendinopathy, plantar fasciitis, anterior knee pain, gastrocnemius strains, and anterior cruciate ligament injuries. Therefore, gaining ankle dorsiflexion range of motion seems to be an important goal in the treatment of lower extremity injuries. Manual therapy has been proposed as a possible treatment to improve mobility and restore arthrokinematics of joints. Movement mobilization is the concept of active joint mobilization. The aim is to render painful movement disorder painless and allow the patient to engage in normal functional activity in the progressive recovery process. Talocrural mobilization with the movement technique is an extension of traditional joint mobilizations and allows the patient to engage in therapy in an active, partial weight-bearing lunge position. There are variations of this technique that can be applied by the clinician or by the individual himself. There are studies showing the effect of clinician-applied motion mobilization on range of motion, static balance, gait, and plantar pressure in different populations. In a study conducted by Reid et al. in individuals with ankle sprains, they observed an increase in ankle dorsiflexion joint range of motion immediately after mobilization with motion for the talocrural joint. In their study, Vicenzino et al. demonstrated the curative effect of motion mobilization techniques on posterior talar shift and dorsiflexion range of motion in individuals with recurrent lateral ankle sprains. Based on this result, they stated that this technique should be considered in rehabilitation programs after lateral ankle sprain. Tomruk et al. showed that the application of the motion mobilization technique to the ankle joint significantly improved postural control in the anteroposterior direction compared to the sham group in healthy individuals. However, overall postural control and dorsiflexion range of motion were significantly increased in both groups compared with initial measurements. On the other hand, the stability limit reaction time was significantly shortened in the motion-only group. In their study, Marrón-Gómez et al. stated that the application of motion mobilization technique and manipulation of the talocrural joint significantly improved ankle dorsiflexion in participants with chronic ankle instability. No significant difference was found between these two techniques, but the results of the application of the motion mobilization technique before the application and the evaluation two days after the application showed larger in-group effect sizes than the high speed and low intensity talocrural joint manipulation. When both treatments were compared with the placebo group, both active interventions were more effective in improving dorsiflexion with larger effect sizes. Yoon et al. reported that passive ankle dorsiflexion improved range of motion, heel-rise time, and dynamic plantar loading during 5-minute walking with a modified motion mobilization technique using talus gliding taping in individuals with limited ankle dorsiflexion. An and Won found that motion ankle mobilization was more effective than simple weight bearing in improving walking speed in stroke patients with limited ankle motion. Gilbreath et al., in their study, showed that there was no significant change in weight-bearing dorsiflexion joint range of motion, in any aspect of the Star Excursion Balance Test, or in Foot and Ankle Ability Measurement-Activities of Daily Living scores after three sessions of motion mobilization technique in individuals with chronic ankle instability. . Although there was no significant change in these parameters, they found a significant improvement in Foot and Ankle Ability Measurement-Sports-Related Activities scores after intervention. Despite these studies investigating the effectiveness of movement mobilization applied by the clinician in different pathologies, there is only one study in the literature comparing the movement applied by the clinician and the individual and the mobilization technique. Stanek and Pieczynski, in their study in healthy individuals with dorsiflexion limitation, stated that both the clinician-applied mobilization and self-mobilization showed significant and sudden increases in the active weight-bearing dorsiflexion joint range of motion when compared to the control group, both while kneeling and standing. They found no significant difference between the groups to which the technique was applied. Based on the findings of this study, clinicians can prescribe self-administered mobilization technique to their patients and expect similar results to clinician-administered mobilization. However, only active dorsiflexion range of motion was evaluated in this study. Although there are studies showing the effect of the movement mobilization technique applied by the clinician on the active dorsiflexion range of motion, foot plantar pressure, jumping and balance, no study has been found in the literature comparing the movements applied by the clinician and the individual in terms of foot plantar pressure, jumping and dynamic balance. Therefore, the aim of this study is to compare the effects of these two techniques in terms of active dorsiflexion range of motion, plantar pressure, jump and dynamic balance in individuals with limited dorsiflexion range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- There will be three separate groups in the study. The individuals in the group will be completely different individuals. Each group will receive a different intervention. One of the groups will be the control group
| Arm | Type | Receives |
|---|---|---|
| The group which mobilization with movement technique applied by clinician | Experimental | Other: Mobilization with movement for Ankle17 individuals in this group, after evaluations, mobilization with movement technique applied by clinician and after that same evaluations will be applied |
| The group which mobilization with movement technique applied by individual himself | Experimental | Other: Mobilization with movement for Ankle17 individuals in this group, after evaluations, mobilization with movement technique applied by individual himself and after that same evaluations will be applied |
| Control Group | No intervention | –16 individuals in this control group, Relevant Extremity will assume a lunge position on a firm mattress with the foot in a weight-bearing stance and the foot in a neutral position. The person will feel uncomfortable and/or the parts will suddenly lunge until the end of their range of motion. No mobilization technique will be applied |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-35
- Volunteering to participate in the study
- Active Dorsiflexion range of motion is below 45˚
Key exclusion criteria (3 listed)
- Having a history of ankle pain and injury in the last 6 months
- Having a Neurological, Rheumatological or Systemic disease
- Having had any lower extremity surgery
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 |
|---|---|---|
| Mobilization with movement for AnkleThe participant will assume a lunge position on a rigid serving table with the relevant extremity in a weight-bearing stance and the foot in a neutral position. An inelastic belt will be placed around the clinician's waist, flush with the lower edge of the medial malleolus, around the distal tibia and fibula. The clinician will stabilize the talus and forefoot with the web spacing of the hands and pressure dimensions on the talus and forefoot, and maintain posterior to anterior sliding of the tibia over the talus using the arch. The clinician will continue to apply pressure while the person is reporting discomfort and/or while the lunge moves, which will continue until the end of the range of motion. Mobilization will be performed as a 3 set of 10 repetitions. | Other | The group which mobilization with movement technique applied by clinician, The group which mobilization with movement technique applied by individual himself |
Primary outcome
Active dorsiflexion range of motion (Degree)
Time frame: 2 Minutes
Active dorsiflexion range of motion will be evaluated with the Weight Bearing Lunge test. The Weight Bearing Lunge test will be performed using a digital inclinometer. The inclinometer will be placed 15 cm below the anterior part of the tibia and the maximum tibial inclination will be measured while the participant is standing, knee flexed, while transferring weight without lifting the heel off the ground.
Balance (Centimeter)
Time frame: 10 Minutes
Y balance test will be used to evaluate the dynamic balance. Participants will be asked to stand barefoot on the weight-bearing platform with their toes positioned back. Then, the participants will be asked to reach anteriorly (ANT), posteromedially (PM), and posterolaterally (PL) three times with their non-weight-bearing extremity.
Gait (second, meter)
Time frame: 2 Minutes
Gait analysis will be evaluation with BTS G-WALK device. The G-walk will be placed on the Lumbal 5 level of each participant with the help of a belt. Participants will be asked to walk 8 m at their normal walking speed, turn, and return to their starting point. In this process, the spatiotemporal parameters of the gait will be evaluated.
Jumping (Centimeter)
Time frame: 3 Minutes
Jumping performance will be evaluation with BTS G-WALK device. For evaluation, participants will keep their hands on their hips. Three attempts will be made before proceeding to the test. Individuals will be asked to reach the highest possible vertical length with each jump on the dominant leg. Three attempts will be recorded and the average of the jump height and anaerobic performance values for analysis.
Foot Plantar Pressure (centimeter2, contact area %)
Time frame: 3 Minutes
Foot plantar pressure will be evaluated using a pedobarographic device. For the measurement, the participants will be asked to stand on the pedobarographic device in a fixed position with bare feet and feet at shoulder level. Participants will be instructed to look across at a fixed point with arms relaxed at both sides. Within the plantar pressure analysis measurements; in static conditions, percentage of contact (%), maximal pressure (N/cm²) and contact area for the dominant foot (cm²), contact surface (%), loads on the fore and hind feet (%) will be determined and recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 24679362Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
- Background: PubMed 35042057Hernandez-Guillen D, Roig-Casasus S, Tolsada-Velasco C, Garcia-Gomariz C, Blasco JM. Talus mobilization-based manual therapy is effective for restoring range of motion and enhancing balance in older adults with limited ankle mobility: A randomized controlled trial. Gait Posture. 2022 Mar;93:14-19. doi: 10.1016/j.gaitpost.2022.01.005. Epub 2022 Jan 10.
- Background: PubMed 31681500Brumitt J, Patterson C, Dudley R, Sorenson E, Hill G, Peterson C. COMPARISON of LOWER QUARTER Y-BALANCE TEST SCORES for FEMALE COLLEGIATE VOLLEYBALL PLAYERS BASED on COMPETITION LEVEL, POSITION, and STARTER STATUS. Int J Sports Phys Ther. 2019 Jun;14(3):415-423. doi: 10.26603/ijspt20190415.
- Background: PubMed 28119881Awotidebe TO, Ativie RN, Oke KI, Akindele MO, Adedoyin RA, Olaogun MO, Olubayode TE, Kolawole BA. Relationships among exercise capacity, dynamic balance and gait characteristics of Nigerian patients with type-2 diabetes: an indication for fall prevention. J Exerc Rehabil. 2016 Dec 31;12(6):581-588. doi: 10.12965/jer.1632706.353. eCollection 2016 Dec.
- Background: PubMed 36326313Yazici MV, Cobanoglu G, Yazici G. Test-retest reliability and minimal detectable change for measures of wearable gait analysis system (G-Walk) in children with cerebral palsy. Turk J Med Sci. 2022 Jun;52(3):658-666. doi: 10.55730/1300-0144.5358. Epub 2022 Jun 16.
- Background: PubMed 27172267Rodriguez-Rosell D, Mora-Custodio R, Franco-Marquez F, Yanez-Garcia JM, Gonzalez-Badillo JJ. Traditional vs. Sport-Specific Vertical Jump Tests: Reliability, Validity, and Relationship With the Legs Strength and Sprint Performance in Adult and Teen Soccer and Basketball Players. J Strength Cond Res. 2017 Jan;31(1):196-206. doi: 10.1519/JSC.0000000000001476.
- Background: PubMed 25329350Rabin A, Kozol Z, Spitzer E, Finestone AS. Weight-bearing ankle dorsiflexion range of motion-can side-to-side symmetry be assumed? J Athl Train. 2015 Jan;50(1):30-5. doi: 10.4085/1062-6050-49.3.40. Epub 2014 Oct 20.
- Background: PubMed 34057133Lee J, Park C, Cha Y, You JSH. Comparative effects of different manual techniques on electromyography activity, kinematics, and muscle force in limited ankle dorsiflexion syndrome. J Back Musculoskelet Rehabil. 2021;34(6):1105-1112. doi: 10.3233/BMR-200257.
- Background: PubMed 31944252Hernandez-Guillen D, Blasco JM. A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults. Phys Ther. 2020 Apr 17;100(4):645-652. doi: 10.1093/ptj/pzaa003.
- Background: PubMed 33401232Gogate N, Satpute K, Hall T. The effectiveness of mobilization with movement on pain, balance and function following acute and sub acute inversion ankle sprain - A randomized, placebo controlled trial. Phys Ther Sport. 2021 Mar;48:91-100. doi: 10.1016/j.ptsp.2020.12.016. Epub 2020 Dec 23.
- Background: PubMed 27765557An CM, Jo SO. Effects of Talocrural Mobilization with Movement on Ankle Strength, Mobility, and Weight-Bearing Ability in Hemiplegic Patients with Chronic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):169-176. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.005. Epub 2016 Oct 17.
- Background: PubMed 24834500Gilbreath JP, Gaven SL, Van Lunen L, Hoch MC. The effects of mobilization with movement on dorsiflexion range of motion, dynamic balance, and self-reported function in individuals with chronic ankle instability. Man Ther. 2014 Apr;19(2):152-7. doi: 10.1016/j.math.2013.10.001.
- Individual participant dataSharing planned: No
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.
Muhammed Yusuf DEMIRKAN, Bachelors study chair
Kırıkkale University
Nevin GUZEL, Prof. study chair
Gazi University
Gamze COBANOGLU, Master study chair
Gazi 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 Mobilization with movement for Ankle in people with Dorsiflexion Deformity of Foot, run by Muhammet Ayhan ORAL 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 3 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: finished, as of the sponsor's last update on 29 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Active dorsiflexion range of motion (Degree) (time frame: 2 Minutes). The study lists 5 primary outcomes in all. 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 NCT05814029, which also lists 17 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 29 Mar 2024.