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THE EFFECT OF TALOCRURAL JOINT AND SUBTALAR JOINT MULLİGAN MOBILIZATION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788629
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Caner Karartı, Hacettepe University

Brief Summary:

Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility is a common impairment in patients with stroke whose DF-PROM has been shown to be approximately half of that in healthy subjects. As a result, these patients have impaired dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM) as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by applying a posteroanterior tibia glide over a fixed talus while the patient actively moves into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle instability and has been proven effective in improving DF-PROM and standing balance. Subtalar MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by flexing patient' knee.

The effects of talocrural and subtalar MWM have not been investigated in patients with stroke. Therefore, the purpose of the present study is to examine the effects of talocrural and subtalar MWM on foot posture, range of motion, gait, and balance in stroke patients with limited ankle mobility.


Condition or disease Intervention/treatment Phase
Hemiplegia, Spastic Other: Talocrural joint MWM mobilization Other: Subtalar joint MWM mobilization Other: Bobath Concept Not Applicable

Detailed Description:

Neural factors, such as spasticity, or an increase in the sensitivity of the myotatic reflex, can contribute significantly to calf muscle stiffness. Likewise, non-neural factors, such as immobilization and age-induced changes in the mechanical properties of muscle and connective tissue, are known to increase resistance to joint movement and to contribute to the limited DF-PROM. Both neural and non-neural factors can impair ankle motion, resulting in balance impairments during standing or gait. Limited DF-PROM can alter foot positioning in weight bearing, resulting in hyperextension of the knee, and decreased ability to shift the center of gravity (COG) during standing and gait. A variety of interventions, such as stretching and joint mobilization, have been attempted to attenuate the effects of limited DF-PROM and to reduce further deterioration in patients post stroke. Both stretching and joint mobilization have been proven effective for improving ankle passive range of motion in patients with stroke; however, there is a limit to the durability of the effect and improvements in functional ability. For this reason, improvements in joint range of motion (ROM) must be accompanied by gains in muscle strength to improve functional ability. This is especially true for patients with hemiplegia who are not capable of weight bearing symmetrically and require additional training, including repetitive and continuous weight bearing on the paretic lower limb.

Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility is a common impairment in patients with stroke whose DF-PROM has been shown to be approximately half of that in healthy subjects. As a result, these patients have impaired dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM) as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by applying a posteroanterior tibia glide over a fixed talus while the patient actively moves into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle instability and has been proven effective in improving DF-PROM and standing balance. Subtalar MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by flexing patient' knee.

The effects of talocrural and subtalar MWM have not been investigated in patients with stroke. Therefore, the purpose of the present study is to examine the effects of talocrural and subtalar MWM on foot posture, range of motion, gait, and balance in stroke patients with limited ankle mobility.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Single (Care Provider)
Masking Description: Single blinded
Primary Purpose: Treatment
Official Title: THE EFFECT OF TALOCRURAL JOINT AND SUBTALAR JOINT MULLİGAN MOBILIZATION ON THE FOOT POSTURE, RANGE OF MOTION, GAIT, AND BALANCE IN CHRONIC HEMIPLEGIC INDIVIDUALS.
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group 1
Talocrural joint Mulligan MWM techniques were applied to this group in addition to conventional therapy.
Other: Talocrural joint MWM mobilization
There were three groups for this study. In addition to conventional treatment group (control group), one of the study groups was performed talocrural joint mobilization.

Active Comparator: Study Group 2
Subtalar joint Mulligan MWM techniques were applied to this group in addition to conventional therapy.
Other: Subtalar joint MWM mobilization
There were three groups for this study. In addition to conventional treatment group (control group), one of the study groups was performed subtalar joint mobilization

Control Group
The therapist used principles that were based on the Bobath concept and aimed at re-educating normal movement during functional activities that were meaningful to the patients in control group. Thirty-five potential treatment techniques or activities in sitting, standing, and supine/side-lying positions were identified. For the purpose of analysis, with the assistance of the 3 therapists who were experienced in the use of the Bobath concept, the treatment techniques and activities were grouped into 4 categories according to the treatment goals of preparation, facilitated movements, gait-specific activities, and functional activities.
Other: Bobath Concept
There were three groups for this study. This group was control group.




Primary Outcome Measures :
  1. Range of Motion [ Time Frame: 6 weeks ]
    To measure passive range of motion (PROM) of the ankle, the subject was seated in the chair of the isokinetic dynamometer with the foot pressed firmly against a foot plate attached to the dynamometer and the knee flexed at 30°. Prior to measurement, the subject's feet and the corresponding footplates were fixed firmly using a Velcro strap; measurements were taken passively from maximal plantarflexion to maximal dorsiflexion. Maximal plantarflexion was defined as the maximum angle before the forefoot lifted from the surface of the foot plate, while maximal dorsiflexion was defined as the maximum angle before the heel lifted off the surface of the foot plate. The ankle active ROM (AROM) test measured the range of active motion from plantarflexion to dorsiflexion.


Secondary Outcome Measures :
  1. Isokinetic Strength Dynamometer [ Time Frame: 6 weeks ]
    Maximal concentric contraction was measured for the dorsiflexors and plantarflexors using an isokinetic dynamometer (Biodex System Pro 4 Isokinetic Strength Dynamomter , Inc., Shirley, NY). The participants were seated with the ankle joint axis aligned.with the mechanical axis of the dynamometer. A performed practice trial to familiarize themselves with the test protocol, the participants were instructed to push and pull the attachment as hard and as fast as possible. Five maximum concentric contractions were performed at 30°/s and the peak torque generated over 5 repetitions was recorded and normalized to body weight (Nm/kg).

  2. Foot Posture Index (FPI-6) [ Time Frame: 6 weeks ]
    It is a clinical tool used to quantify the degree to which a foot is pronated, neutral or supinated. It is a measure of standing foot posture and so is not a replacement for gait assessment where time and facilities exist. It is however a more valid approach than many of the static weightbearing and non-weightbearing goniometric measures currently used in clinic.The patient should stand in their relaxed stance position with double limb support. The patient should be instructed to stand still, with their arms by the side and looking straight ahead. It may be helpful to ask the patient to take several steps, marching on the spot, prior to settling into a comfortable stance position. The patient will need to stand still for approximately two minutes in total in order for the assessment to be conducted. The assessor needs to be able to move around the patient during the assessment and to have uninterrupted access to the posterior aspect of the leg and foot.

  3. Navicular Drop Test (NDT) [ Time Frame: 6 weeks ]
    It's intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position to a relaxed position in standing. Position the patient in standing so there is full weight-bearing through the lower extremity and ensure the foot is in the subtalar joint neutral position ("talar head congruent"). Mark the location of the navicular tuberosity and measure its distance from the supporting surface (floor or step). Ask the patient to relax and then measure the amount of sagittal plane excursion of the navicular with a ruler. Alternatively, the test can also be performed in reverse, i.e. measuring from relaxed position up to talar neutral. Many clinicians also choose to perform this test by marking the start and end position of the navicular on an index card placed along the inside of the foot and then measure the change with a ruler.

  4. Timed up and Go Test [ Time Frame: 6 weeks ]
    To determine fall risk and measure the progress of balance, sit to stand and walking.The patient starts in a seated position.The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. Be sure to document the assistive device used.

  5. Berg Balance Scale [ Time Frame: 6 weeks ]
    The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  6. Biodex Gait Trainer Treadmill System (BGTTS) [ Time Frame: 6 weeks ]
    The BGTTS system is designed specifically for rehabilitation and retraining of gait for patients with neurologic and orthopaedic gait dysfunctions. The treadmill permits walking to be initiated from 0.0 km/h and increased by increments of 0.16 km/h. The patient can also hold onto a horizontal bar attached to the front of the treadmill for stability. The bodyweight support system includes an overhead harness with a pelvic band that attaches around the hips and 2 thigh straps with anterior and posterior attachments to the pelvic band. The harness vertically supports the patient over the treadmill and is attached to a suspension system with a force transducer that signals the amount of body weight supported.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • hemiplegic stroke (>6 months post stroke),
  • ability to perform a single-leg lunge on the paretic lower limb onto a stool from a standing position,
  • ability to walk without an assistive device for more than 10 m,
  • limited dorsiflexion passive ROM with contracture of the paretic ankle, and capability of following simple verbal instructions.

Exclusion Criteria:

  • visual impairment,
  • unilateral neglect,
  • aphasia.
  • contraindications for joint mobilization (i.e., ankle joint hypermobility, trauma, or inflammation),
  • ankle sprain in the previous 6 weeks,
  • any history of ankle surgery,
  • and those concurrently receiving similar interventions outside of the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788629


Locations
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Turkey
Caner KARARTI
Kırşehir, Turkey, 40100
Sponsors and Collaborators
Hacettepe University

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Responsible Party: Caner Karartı, Caner Karartı, Hacettepe University, Hacettepe University
ClinicalTrials.gov Identifier: NCT03788629    
Other Study ID Numbers: 2018500
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caner Karartı, Hacettepe University:
hemiplegia
foot
mobilization
Additional relevant MeSH terms:
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Hemiplegia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paralysis