Hemiplegia, SpasticNCT03788629
THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE
A study testing Talocrural joint MWM mobilization and Subtalar joint MWM mobilization in people with Hemiplegia, Spastic, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- Talocrural joint MWM mobilization and Subtalar joint MWM mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 20 Sep 2018
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECTS OF SUBTALAR JOINT MOBILIZATION WITH MOVEMENT ON MUSCLE STRENGTH, BALANCE, FUNCTIONAL PERFORMANCE AND GAIT PARAMETERS IN PATIENTS WITH CHRONIC STROKE
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.
Read the 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.
- Conditions
- Hemiplegia, Spastic
- Being tested
- Talocrural joint MWM mobilization, Subtalar joint MWM mobilization
- Keywords
- hemiplegia, foot, mobilization
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talocrural joint MWM mobilizationOther
There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.
Subtalar joint MWM mobilizationOther
There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group. Receives: Other: Talocrural joint MWM mobilization |
| Study Group 2 | Active comparator | Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques Receives: Other: Subtalar joint MWM mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
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 posted27 Dec 2018
- Study start30 Jun 2018
- Primary completion20 Aug 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, SpasticStudies 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 (actual)
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
- NCT03788629
- Sponsor's protocol ID
- 2018500
- Status last verified
- Apr 2020
- First submitted
- 25 Dec 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF SUBTALAR JOINT MOBILIZATION WITH MOVEMENT ON MUSCLE STRENGTH, BALANCE, FUNCTIONAL PERFORMANCE AND GAIT PARAMETERS IN PATIENTS WITH CHRONIC STROKE
- ClinicalTrials.gov ID
- NCT03788629
- Acronym / sponsor ID
- 2018500
- Conditions
- Hemiplegia, Spastic
- Keywords
- hemiplegia, foot, mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 27 Dec 2018 (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.
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.
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 |
|---|---|---|
| Study Group 1 | Experimental | Other: Talocrural joint MWM mobilizationBobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group. |
| Study Group 2 | Active comparator | Other: Subtalar joint MWM mobilizationSubtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- visual impairment,
- unilateral neglect,
- aphasia.
- contraindications for joint mobilization (i.e., ankle joint hypermobility, trauma, or inflammation),
- ankle sprain in the previous 6 weeks,
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 |
|---|---|---|
| Talocrural joint MWM mobilizationThere were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed. | Other | Study Group 1 |
| Subtalar joint MWM mobilizationThere were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed. | Other | Study Group 2 |
Primary outcome
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).
3 secondary outcomes
Timed up and Go Test
Time frame: 6 weeks
Berg Balance Scale
Time frame: 6 weeks
Biodex Gait Trainer Treadmill System (BGTTS)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talocrural joint MWM mobilization and Subtalar joint MWM mobilization in people with Hemiplegia, Spastic, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Strength Dynamometer (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.