The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance
Primary Purpose
Hemiplegia, Gait, Hemiplegic, Mobility Limitation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proximal And Distal Tibiofibular Joint Manipulations
Bobath Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental-Study Group
Control Group
Arm Description
In addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04178369
First Posted
November 25, 2019
Last Updated
November 25, 2019
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT04178369
Brief Title
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance
Official Title
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance in Chronic Hemiplegic Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Anticipated)
Primary Completion Date
March 20, 2020 (Anticipated)
Study Completion Date
April 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Gait, Hemiplegic, Mobility Limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Care Provider
Masking Description
Single blinded
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental-Study Group
Arm Type
Experimental
Arm Description
In addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proximal And Distal Tibiofibular Joint Manipulations
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bobath Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot Posture Index
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Range of Motion
Description
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.
Time Frame
6 weeks
Title
Berg Balance Scale
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caner KARARTI, PT, MSc.
Phone
03862805362
Email
fzt.caner.92@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Çağdaş BASAT, Assoc. Prof.
Phone
+905057721489
Email
cagdasbasat@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27065565
Citation
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.
Results Reference
result
PubMed Identifier
27765557
Citation
An 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 Reference
result
PubMed Identifier
18295622
Citation
Kluding 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.
Results Reference
result
Learn more about this trial
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance
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