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THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE

Primary Purpose

Hemiplegia, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Talocrural joint MWM mobilization
Subtalar joint MWM mobilization
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia, Spastic focused on measuring hemiplegia, foot, mobilization

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Caner KARARTI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group 1

Study Group 2

Arm Description

Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group.

Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques

Outcomes

Primary Outcome Measures

Isokinetic Strength Dynamometer
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).

Secondary Outcome Measures

Timed up and Go Test
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.
Berg Balance Scale
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.
Biodex Gait Trainer Treadmill System (BGTTS)
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.

Full Information

First Posted
December 25, 2018
Last Updated
April 5, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03788629
Brief Title
THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE
Official Title
THE EFFECTS OF SUBTALAR JOINT MOBILIZATION WITH MOVEMENT ON MUSCLE STRENGTH, BALANCE, FUNCTIONAL PERFORMANCE AND GAIT PARAMETERS IN PATIENTS WITH CHRONIC STROKE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

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
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 subtalar MWM have not been investigated in patients with stroke. Therefore, the purpose of the present study is to examine the effects of subtalar MWM on muscle strength, balance, functional performance, and gait parameters in patients with chronic stroke.
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 subtalar MWM have not been investigated in patients with stroke. Therefore,the purpose of the present study is to examine the effects of subtalar MWM on muscle strength, balance, functional performance, and gait parameters in patients with chronic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Spastic
Keywords
hemiplegia, foot, mobilization

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group.
Arm Title
Study Group 2
Arm Type
Active Comparator
Arm Description
Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques
Intervention Type
Other
Intervention Name(s)
Talocrural joint MWM mobilization
Intervention Description
There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.
Intervention Type
Other
Intervention Name(s)
Subtalar joint MWM mobilization
Intervention Description
There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.
Primary Outcome Measure Information:
Title
Isokinetic Strength Dynamometer
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Timed up and Go Test
Description
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.
Time Frame
6 weeks
Title
Berg Balance Scale
Description
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.
Time Frame
6 weeks
Title
Biodex Gait Trainer Treadmill System (BGTTS)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Caner KARARTI
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

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THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE

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