- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178369
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance
The Effects of Proximal And Distal Tibiofibular Joint Manipulations on Foot Posture, Ankle Range of Motion, and Balance in Chronic Hemiplegic Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental-Study Group
In addition to the conservative treatment of the control group, proximal and distal tibiofibular joint manipulations will be applied for 6 weeks.
|
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. |
ACTIVE_COMPARATOR: Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Berg Balance Scale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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