HemiplegiaNCT04178369
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance
A study testing Proximal And Distal Tibiofibular Joint Manipulations and Bobath Treatment in people with Hemiplegia and Gait, Hemiplegic, run by Hacettepe University.
Trial summary
Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemiplegia, Gait, Hemiplegic, Mobility Limitation
- What is being tested?
- Proximal And Distal Tibiofibular Joint Manipulations and Bobath Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2019to 20 Apr 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of chronic hemiplegia (˃6 months),
- the ability to stand on the hemiplegic leg on a 30-cm-high step-board,
- the ability to walk at least 10 m without any assistive device,
- presence of limitation in ankle passive dorsiflexion (contracture),
- the ability to understand and follow verbal commands,
- to be volunteer to participate in the study.
Who cannot join
- presence of any condition that is considered as a contraindication for mobilization (such as hypermobility, trauma, inflammation, etc.),
- presence of any visual, verbal, or cognitive defects (such as aphasia, unilateral neglect, etc.),
- having ankle sprain during the past 6 weeks,
- patients who had undergone foot-ankle surgeries,
- to receive any additional treatment within the time period of our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance in Chronic Hemiplegic Individuals
Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. While biomechanical studies emphasized the importance of proximal tibiofibular joint and distal tibiofibular joint manipulations for ankle dorsiflexion, no studies examining the effect of corrective manipulation techniques applied to these two joints on foot posture, range of motion and balance were observed.
Read the detailed description
In chronic hemiplegic individuals, gait loss due to biomechanical disorders of the talocrural joint (TCJ) and subtalar joint (STJ) affects 50% of the population. Although foot posture is seen at the same rate in pronation and supination, approximately 30% of individuals have abnormal and asymmetric foot posture. In particular, foot posture in the direction of plantar flexion and inversion leads to limited ankle mobility. Loss of mobility can be caused by non-neural factors as well as neural factors such as spasticity and increased myostatic reflex. Due to long-term immobilization, negative changes are seen in the tissues such as bone, muscle, tendon and ligament and especially ankle dorsiflexion is limited. Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. The main problem is the timing of the posterior foot plantar flexion after the first contact at the beginning of the posture phase; in the late phase, defective heel and forefoot rocker roll mechanism due to the failure of forward weight transfer. For these reasons, foot posture, ankle joint range of motion and balance are adversely affected in hemiplegic individuals. Biomechanical problems related to foot deformities in chronic hemiplegic individuals have been frequently associated with TCJ and STJ anomalies. However, in biomechanical studies, it is emphasized that proximal tibiofibular joint (PTFJ) and distal tibiofibular joint (DTFJ) have important roles in optimal ankle dorsiflexion. Although PTFJ is anatomically belonging to the knee, it is evaluated within the foot-ankle complex as a function. PTFJ makes slip movements during movement in TCJ. Limitations in PTFJ movement result in limitation of the endpoints of normal ankle joint movement and anterior pain in the ankle during weight bearing. Increased tension in the lateral ligaments due to plantar flexion and inversion anomalies and traumas of the ankle applies inferior directional traction force to the distal fibula.This leads to fibular rotation in the parasagittal plane. Anterior and inferior movement of the distal fibula causes inferior and posterior shifting of the PTFJ and the PTFJ locks. This locking restricts the movement of the entire fibula during ankle movements and leads to a limitation of dorsiflexion of TCJ. It is emphasized that ankle posture significantly affects DTFJ in addition to PTFJ. The anterior ligament of DTFJ is closely related to the anterior talofibular ligament (ATFL). Plantar flexion and inversion of the trauma or supination of the foot posture, etc. conditions increase the tension in the lateral ligaments and cause pathologies in ATFL. This situation adversely affects the anterior ligament of DTFJ, leading to instability risk in this joint and loss of dorsiflexion in TCJ. While biomechanical studies emphasized the importance of proximal tibiofibular joint and distal tibiofibular joint manipulations for ankle dorsiflexion, no studies examining the effect of corrective manipulation techniques applied to these two joints on foot posture, range of motion and balance were observed. It is thought that PTFJ and DTFJ also have an effect on the above mentioned biomechanical chain in functional deficiencies caused by foot posture in the direction of plantar flexion and inversion. Therefore, we aimed to investigate the effects of PTFJ and DTFJ manipulation techniques on foot posture, range of motion and balance parameters in chronic hemiplegic subjects.
- Conditions
- Hemiplegia, Gait, Hemiplegic, Mobility Limitation
- Being tested
- Proximal And Distal Tibiofibular Joint Manipulations, Bobath Treatment
- Medical subject headings
- Hemiplegia, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal And Distal Tibiofibular Joint ManipulationsOther
For PTFJ, the experimental intervention will be based on previously published methods. Physiotherapist will make contact with the fibular head, extending to the popliteal fossa. The associated soft tissue will be pulled in a lateral direction until the metacarpophalangeal joint will be firmly stabilized behind the fibular head.
For DTFJ, the experimental intervention will be conducted according to previously published methods. Physiotherapist will grasp and stabilize the distal tibia with one hand and grasp the distal fibula between the finger and thenar eminence of the other hand. The fibula will be translated posteriorly until the restrictive barrier (end range) will be engaged. Then a high-velocity, low-amplitude thrust will be applied through the fibula in a posterior-superior direction.
Bobath TreatmentOther
All participants will be given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept for 5 days a week, 45 minutes each. The techniques will be applied by a physiotherapist who is specialized in Bobath concept. 35 different techniques will be used to improve the selective control and weight transfer of the pelvis in sitting, standing and supine/side lying positions. Moreover, soft tissue mobilization will be also used to relieve tension and loosen stiff tissues to provide biomechanical alignment and reduce pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Study Group | Experimental | In addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks. Receives: Other: Proximal And Distal Tibiofibular Joint Manipulations |
| Control Group | Active comparator | All participants were given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept (conservative treatment) for 5 days a week, 45 minutes each. Receives: Other: Bobath Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index
This index will be used to evaluate foot posture. During the assessment, all individuals will be asked to stand in the position where they fell the most comfortable. Six different parameters of the foot posture will be evaluated and scored between (-2) and (+2). These six parameters will be as follows: the palpation of talus head in hindfoot with the thumb and forefinger, the slope above and beneath the lateral malleolus, calcaneal supination and pronation, domination at the talonavicular joint area in the forefoot, the structure of medial longitudinal arc, and adduction and abduction of the forefoot compared to the hindfoot. The parameters scored as 0 will be considered as neutral position, while positive values represent pronation, and negative values express supination.
Measured: 6 weeks
Secondary outcomes (2)
Range of Motion
Ankle ROM will be measured in the prone position and asked to flex the knee to 90°. The central axis of a 14 in. plastic goniometer will be placed on the lateral malleolus. The stationary arm of the goniometer will be placed parallel to the lateral side of the fifth metatarsal bone. The moving arm of the goniometer will be placed parallel to the center of the fibular head, and the 3 axes will be marked with a dot. The 3 marked dots will be maintained in the same position throughout the duration of the test. One physical therapist will maintain a neutral subtalar joint position while applying force to the plantar surface of the forefoot and midfoot until further movement will be firmly restricted. The second physical therapist will confirm the neutral subtalar joint position and independently measure the ankle passive and active ROM. Measurements of ankle ROM will be repeated 3 times, with results averaged for ankle ROM data analysis.
Measured: 6 weeks
Berg Balance Scale
Berg Balance Scale will be used to evaluate balance. Each of the 14 items of this scale will be scored between 0 to 4, where 0 indicated that the movement cannot be performed and 4 indicated that the movement is performed in the best possible way. The highest possible score on this scale is 56. High scores indicate increased postural control.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Dec 2019 (estimated)
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Randomized
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178369
- Sponsor's protocol ID
- 2019600
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
An CM, Won JI. Effects of ankle joint mobilization with movement and weight-bearing exercise on knee strength, ankle range of motion, and gait velocity in patients with stroke: a pilot study. J Phys Ther Sci. 2016 Jan;28(2):689-94. doi: 10.1589/jpts.28.689. Epub 2016 Feb 29.
PubMed 27065565An 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 27765557Kluding PM, Santos M. Effects of ankle joint mobilizations in adults poststroke: a pilot study. Arch Phys Med Rehabil. 2008 Mar;89(3):449-56. doi: 10.1016/j.apmr.2007.12.005.
PubMed 18295622
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance in Chronic Hemiplegic Individuals
- ClinicalTrials.gov ID
- NCT04178369
- Acronym / sponsor ID
- 2019600
- Conditions
- Hemiplegia, Gait, Hemiplegic, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (estimated)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. While biomechanical studies emphasized the importance of proximal tibiofibular joint and distal tibiofibular joint manipulations for ankle dorsiflexion, no studies examining the effect of corrective manipulation techniques applied to these two joints on foot posture, range of motion and balance were observed.
Detailed description
In chronic hemiplegic individuals, gait loss due to biomechanical disorders of the talocrural joint (TCJ) and subtalar joint (STJ) affects 50% of the population. Although foot posture is seen at the same rate in pronation and supination, approximately 30% of individuals have abnormal and asymmetric foot posture. In particular, foot posture in the direction of plantar flexion and inversion leads to limited ankle mobility. Loss of mobility can be caused by non-neural factors as well as neural factors such as spasticity and increased myostatic reflex. Due to long-term immobilization, negative changes are seen in the tissues such as bone, muscle, tendon and ligament and especially ankle dorsiflexion is limited. Limited ankle dorsiflexion adversely affects the weight bearing capacity, increases the knee extensor moment and causes insufficient maneuvers to change the center of gravity of the body in patients with hemiplegia. The main problem is the timing of the posterior foot plantar flexion after the first contact at the beginning of the posture phase; in the late phase, defective heel and forefoot rocker roll mechanism due to the failure of forward weight transfer. For these reasons, foot posture, ankle joint range of motion and balance are adversely affected in hemiplegic individuals. Biomechanical problems related to foot deformities in chronic hemiplegic individuals have been frequently associated with TCJ and STJ anomalies. However, in biomechanical studies, it is emphasized that proximal tibiofibular joint (PTFJ) and distal tibiofibular joint (DTFJ) have important roles in optimal ankle dorsiflexion. Although PTFJ is anatomically belonging to the knee, it is evaluated within the foot-ankle complex as a function. PTFJ makes slip movements during movement in TCJ. Limitations in PTFJ movement result in limitation of the endpoints of normal ankle joint movement and anterior pain in the ankle during weight bearing. Increased tension in the lateral ligaments due to plantar flexion and inversion anomalies and traumas of the ankle applies inferior directional traction force to the distal fibula.This leads to fibular rotation in the parasagittal plane. Anterior and inferior movement of the distal fibula causes inferior and posterior shifting of the PTFJ and the PTFJ locks. This locking restricts the movement of the entire fibula during ankle movements and leads to a limitation of dorsiflexion of TCJ. It is emphasized that ankle posture significantly affects DTFJ in addition to PTFJ. The anterior ligament of DTFJ is closely related to the anterior talofibular ligament (ATFL). Plantar flexion and inversion of the trauma or supination of the foot posture, etc. conditions increase the tension in the lateral ligaments and cause pathologies in ATFL. This situation adversely affects the anterior ligament of DTFJ, leading to instability risk in this joint and loss of dorsiflexion in TCJ. While biomechanical studies emphasized the importance of proximal tibiofibular joint and distal tibiofibular joint manipulations for ankle dorsiflexion, no studies examining the effect of corrective manipulation techniques applied to these two joints on foot posture, range of motion and balance were observed. It is thought that PTFJ and DTFJ also have an effect on the above mentioned biomechanical chain in functional deficiencies caused by foot posture in the direction of plantar flexion and inversion. Therefore, we aimed to investigate the effects of PTFJ and DTFJ manipulation techniques on foot posture, range of motion and balance parameters in chronic hemiplegic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental-Study Group | Experimental | Other: Proximal And Distal Tibiofibular Joint ManipulationsIn addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks. |
| Control Group | Active comparator | Other: Bobath TreatmentAll participants were given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept (conservative treatment) for 5 days a week, 45 minutes each. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of chronic hemiplegia (˃6 months),
- the ability to stand on the hemiplegic leg on a 30-cm-high step-board,
- the ability to walk at least 10 m without any assistive device,
- presence of limitation in ankle passive dorsiflexion (contracture),
- the ability to understand and follow verbal commands,
Key exclusion criteria (5 listed)
- presence of any condition that is considered as a contraindication for mobilization (such as hypermobility, trauma, inflammation, etc.),
- presence of any visual, verbal, or cognitive defects (such as aphasia, unilateral neglect, etc.),
- having ankle sprain during the past 6 weeks,
- patients who had undergone foot-ankle surgeries,
- to receive any additional treatment within the time period of our study.
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 |
|---|---|---|
| Proximal And Distal Tibiofibular Joint ManipulationsFor PTFJ, the experimental intervention will be based on previously published methods. Physiotherapist will make contact with the fibular head, extending to the popliteal fossa. The associated soft tissue will be pulled in a lateral direction until the metacarpophalangeal joint will be firmly stabilized behind the fibular head. For DTFJ, the experimental intervention will be conducted according to previously published methods. Physiotherapist will grasp and stabilize the distal tibia with one hand and grasp the distal fibula between the finger and thenar eminence of the other hand. The fibula will be translated posteriorly until the restrictive barrier (end range) will be engaged. Then a high-velocity, low-amplitude thrust will be applied through the fibula in a posterior-superior direction. | Other | Experimental-Study Group |
| Bobath TreatmentAll participants will be given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept for 5 days a week, 45 minutes each. The techniques will be applied by a physiotherapist who is specialized in Bobath concept. 35 different techniques will be used to improve the selective control and weight transfer of the pelvis in sitting, standing and supine/side lying positions. Moreover, soft tissue mobilization will be also used to relieve tension and loosen stiff tissues to provide biomechanical alignment and reduce pain. | Other | Control Group |
Primary outcome
Foot Posture Index
Time frame: 6 weeks
This index will be used to evaluate foot posture. During the assessment, all individuals will be asked to stand in the position where they fell the most comfortable. Six different parameters of the foot posture will be evaluated and scored between (-2) and (+2). These six parameters will be as follows: the palpation of talus head in hindfoot with the thumb and forefinger, the slope above and beneath the lateral malleolus, calcaneal supination and pronation, domination at the talonavicular joint area in the forefoot, the structure of medial longitudinal arc, and adduction and abduction of the forefoot compared to the hindfoot. The parameters scored as 0 will be considered as neutral position, while positive values represent pronation, and negative values express supination.
2 secondary outcomes
Range of Motion
Time frame: 6 weeks
Berg Balance Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Results publication: PubMed 27065565An CM, Won JI. Effects of ankle joint mobilization with movement and weight-bearing exercise on knee strength, ankle range of motion, and gait velocity in patients with stroke: a pilot study. J Phys Ther Sci. 2016 Jan;28(2):689-94. doi: 10.1589/jpts.28.689. Epub 2016 Feb 29.
- Results publication: 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.
- Results publication: PubMed 18295622Kluding PM, Santos M. Effects of ankle joint mobilizations in adults poststroke: a pilot study. Arch Phys Med Rehabil. 2008 Mar;89(3):449-56. doi: 10.1016/j.apmr.2007.12.005.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal And Distal Tibiofibular Joint Manipulations and Bobath Treatment in people with Hemiplegia and Gait, Hemiplegic, run by Hacettepe University.
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 6 inclusion and 5 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Caner KARARTI, PT, MSc. (03862805362, fzt.caner.92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Posture Index (time frame: 6 weeks). 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 NCT04178369, which also lists 3 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 26 Nov 2019.