Balance Impairments in Stroke PatientsNCT06887114
Can Lumbar Mulligan Mobilization Improve Gait, Balance, and Trunk Position Sense After Stroke?
A study testing Experimental Group (Mulligan Mobilization + Conventional Therapy) and (Conventional Therapy Only) in people with Balance Impairments in Stroke Patients, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a pathology caused by disturbances in the brain's arterial circulation, leading to high morbidity rates. Individuals who experience a stroke often face neurological impairments such as motor, sensory, and cognitive dysfunctions, which negatively impact muscle strength, postural control, sensation, and gait… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Balance Impairments in Stroke Patients
- What is being tested?
- Experimental Group (Mulligan Mobilization + Conventional Therapy) and (Conventional Therapy Only)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2024to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following conditions to be eligible for the study:
- Diagnosed with stroke by a neurologist.
- Aged 30 to 65 years.
- First-ever stroke (single episode).
- Stroke duration between 6 to 24 months.
- Score of ≤3 on the Modified Rankin Scale (mRS).
- Score of ≥24 on the Mini-Mental State Examination (MMSE).
Who cannot join
- Participants will be excluded if they meet any of the following conditions:
- History of musculoskeletal disorders affecting the spine (e.g., cancer, scoliosis, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis).
- Previous lumbar spine surgery.
- Presence of neurological conditions other than stroke (e.g., Parkinson's disease, multiple sclerosis).
- Severe visual impairment affecting balance or walking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University
Ankara, 06010
Wala'a AlDEGES, Mac, 05457269342, walaa.deges@yahoo.com
Wala'a Al-deges, MSc, 05457269342
About this study
Official title: Effects of Mulligan-Based Lumbar Mobilization on Trunk Position Sense, Balance, and Gait in Stroke Survivors: A Randomized Study
Stroke is a pathology caused by disturbances in the brain's arterial circulation, leading to high morbidity rates. Individuals who experience a stroke often face neurological impairments such as motor, sensory, and cognitive dysfunctions, which negatively impact muscle strength, postural control, sensation, and gait, reducing their independence in daily activities. Balance deficits in stroke patients increase the risk of falls and contribute to a fear of falling. Improving balance control is a key goal in rehabilitation. The importance of the trunk in balance control and rehabilitation is well-established, as it plays a central role in maintaining stability. In individuals with restricted lumbar mobility, weakened trunk muscles and altered muscle activation can lead to a reduction in proprioception, hip strategy, and spinal stabilization, further impairing balance. Combining conventional exercise approaches with other rehabilitation techniques has been shown to yield more effective outcomes. This study aims to investigate the effects of Mulligan-based lumbar spine mobilization on balance, trunk position sense, and gait in individuals with stroke.
Read the detailed description
Stroke is a high-morbidity condition caused by a disruption in the brain's arterial circulation, resulting in various neurological impairments, including motor, sensory, and cognitive deficits. These impairments lead to a decrease in the individual's ability to perform daily activities independently, as muscle strength, postural control, sensation, and gait are negatively affected. Stroke patients often face an increased risk of falls due to balance deficits, which can also contribute to a significant fear of falling. Thus, improving balance control is an essential therapeutic goal in stroke rehabilitation.
The trunk plays a pivotal role in balance control, and it should be the primary focus in rehabilitation programs. In individuals with restricted lumbar mobility, weakened trunk muscles or altered muscle activation patterns lead to decreased lumbar proprioception, impaired hip strategy, and reduced spinal stabilization, all of which contribute to balance difficulties. Recent studies suggest that combining conventional rehabilitation techniques with other interventions can provide more effective results.
In stroke rehabilitation, different mobilization techniques are increasingly being used. One such approach is the Mulligan Concept, which is commonly applied in musculoskeletal disorders, particularly in the treatment of knee, ankle, and shoulder problems in stroke patients. However, there has been limited research on the effectiveness of Mulligan-based lumbar spine mobilization in stroke patients. The Mulligan technique, particularly the Sustained Natural Apophyseal Glides (SNAG) technique, may help improve the individual's ability to move the body freely and enhance mobility and function, ultimately increasing confidence and reducing psychological barriers such as the fear of movement.
This study aims to evaluate the effectiveness of Mulligan-based lumbar mobilization in enhancing balance, trunk position sense, and gait in individuals with stroke. By assessing the impacts of this technique, the study seeks to contribute to the development of more effective rehabilitation strategies that can improve functional outcomes and quality of life for stroke patients.
- Conditions
- Balance Impairments in Stroke Patients
- Being tested
- Experimental Group (Mulligan Mobilization + Conventional Therapy), (Conventional Therapy Only)
- Keywords
- Stroke, Lumbar Mobilization, Mulligan, Balance, Trunk Position Sense and Gait.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group (Mulligan Mobilization + Conventional Therapy)Other
Also called SNAGs technique with conventional rehab, Lumbar SNAGs with rehabilitation exercises, Mulligan spine mobilization with physical therapy exercises, Lumbar mobilization and functional rehabilitation
Mulligan Sustained Natural Apophyseal Glides (SNAGs) applied to the lumbar spine, combined with conventional rehabilitation exercises (neuromuscular training, stretching, strengthening, and balance exercises).
(Conventional Therapy Only)Other
Also called Conventional Physiotherapy, Standard Rehabilitation Exercises, Traditional Physiotherapy Treatment, Conventional Exercise Program
Neuromuscular training, stretching, strengthening, balance exercises, and gait training performed without Mulligan mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants in this group will receive a combination of Mulligan Sustained Natural Apophyseal Glides (SNAGs) and conventional exercises. Receives: Other: Experimental Group (Mulligan Mobilization + Conventional Therapy) |
| Control Group | Active comparator | Participants in this group will receive conventional physiotherapy exercises Receives: Other: (Conventional Therapy Only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance Assessment (Mini-BESTest)
The Mini Balance Evaluation Systems Test (Mini-BESTest) assesses balance control, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. It consists of 14 items scored from 0 to 28, with higher scores indicating better balance.
Measured: Baseline and After 4 Weeks
Static Balance Assessment (ALDA Balance Device)
The ALDA Balance Device uses a motion sensor placed at the L3-5 vertebrae to assess postural sway. It records movement data via a wireless system to analyze balance responses.
Measured: Baseline and After 4 Weeks
Dynamic Balance Assessment (Trunk Impairment Scale - TIS)
The TIS assesses trunk control in stroke patients through three subcomponents: static sitting balance, dynamic sitting balance, and coordination. The scale consists of 17 items, with a total score ranging from 0 to 23, where higher scores indicate better trunk control.
Measured: Baseline and After 4 Weeks
Dynamic Balance Assessment (Functional Reach Test - FRT)
The Functional Reach Test evaluates balance stability by measuring the maximum distance a participant can reach forward while maintaining a fixed base of support. Three trials are conducted, and the average distance is recorded. A reach distance of 15 cm or less indicates a high fall risk.
Measured: Baseline and After 4 Weeks
Gait Performance (Dynamic Gait Index (DGI))
Assesses functional mobility and dynamic walking ability under different conditions (e.g., changing speeds, stepping over obstacles).
Measured: Baseline and After 4 Weeks
Gait Performance (10-Meter Walk Test)
Measures gait speed by recording the time taken to walk 10 meters.
Measured: Baseline and After 4 Weeks
Trunk Position Sense (Proprioception) inclinometers test
Inclinometers are among the most commonly used methods for measuring trunk position sense and proprioception. the participant will be guided into a 30° lumbar flexion position three times while standing and will be asked to memorize this position. Then, the participant will be instructed to close their eyes and attempt to replicate the same position. After returning to an upright stance, they will be asked to find the 30° flexion position again. This process will be repeated three times, and the results will be recorded.
Measured: Baseline and After 4 Weeks
Secondary outcomes (3)
Fall Risk (Timed Up and Go (TUG) Test)
Evaluates functional mobility by measuring the time taken to stand from a chair, walk 3 meters, turn, walk back, and sit down.
Measured: Baseline and After 4 Weeks
Cognitive Function (Standardized Mini Mental Test (SMMT))
Assesses cognitive status, including memory, attention, and visuospatial abilities.
Measured: Baseline and After 4 Weeks
Functional Independence (Barthel Index)
Assesses independence in daily living activities such as mobility, self-care, and transfers.
Measured: Baseline and After 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start8 May 2024
- Primary completion10 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance Impairments in Stroke PatientsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887114
- Sponsor's protocol ID
- 14.03.2024/02-592
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indivudual participant data will be available to the responsible researcher.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan-Based Lumbar Mobilization on Trunk Position Sense, Balance, and Gait in Stroke Survivors: A Randomized Study
- ClinicalTrials.gov ID
- NCT06887114
- Acronym / sponsor ID
- 14.03.2024/02-592
- Conditions
- Balance Impairments in Stroke Patients
- Keywords
- Stroke, Lumbar Mobilization, Mulligan, Balance, Trunk Position Sense and Gait.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
Stroke is a pathology caused by disturbances in the brain's arterial circulation, leading to high morbidity rates. Individuals who experience a stroke often face neurological impairments such as motor, sensory, and cognitive dysfunctions, which negatively impact muscle strength, postural control, sensation, and gait, reducing their independence in daily activities. Balance deficits in stroke patients increase the risk of falls and contribute to a fear of falling. Improving balance control is a key goal in rehabilitation. The importance of the trunk in balance control and rehabilitation is well-established, as it plays a central role in maintaining stability. In individuals with restricted lumbar mobility, weakened trunk muscles and altered muscle activation can lead to a reduction in proprioception, hip strategy, and spinal stabilization, further impairing balance. Combining conventional exercise approaches with other rehabilitation techniques has been shown to yield more effective outcomes. This study aims to investigate the effects of Mulligan-based lumbar spine mobilization on balance, trunk position sense, and gait in individuals with stroke.
Detailed description
Stroke is a high-morbidity condition caused by a disruption in the brain's arterial circulation, resulting in various neurological impairments, including motor, sensory, and cognitive deficits. These impairments lead to a decrease in the individual's ability to perform daily activities independently, as muscle strength, postural control, sensation, and gait are negatively affected. Stroke patients often face an increased risk of falls due to balance deficits, which can also contribute to a significant fear of falling. Thus, improving balance control is an essential therapeutic goal in stroke rehabilitation.
The trunk plays a pivotal role in balance control, and it should be the primary focus in rehabilitation programs. In individuals with restricted lumbar mobility, weakened trunk muscles or altered muscle activation patterns lead to decreased lumbar proprioception, impaired hip strategy, and reduced spinal stabilization, all of which contribute to balance difficulties. Recent studies suggest that combining conventional rehabilitation techniques with other interventions can provide more effective results.
In stroke rehabilitation, different mobilization techniques are increasingly being used. One such approach is the Mulligan Concept, which is commonly applied in musculoskeletal disorders, particularly in the treatment of knee, ankle, and shoulder problems in stroke patients. However, there has been limited research on the effectiveness of Mulligan-based lumbar spine mobilization in stroke patients. The Mulligan technique, particularly the Sustained Natural Apophyseal Glides (SNAG) technique, may help improve the individual's ability to move the body freely and enhance mobility and function, ultimately increasing confidence and reducing psychological barriers such as the fear of movement.
This study aims to evaluate the effectiveness of Mulligan-based lumbar mobilization in enhancing balance, trunk position sense, and gait in individuals with stroke. By assessing the impacts of this technique, the study seeks to contribute to the development of more effective rehabilitation strategies that can improve functional outcomes and quality of life for stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Experimental Group (Mulligan Mobilization + Conventional Therapy)Participants in this group will receive a combination of Mulligan Sustained Natural Apophyseal Glides (SNAGs) and conventional exercises. |
| Control Group | Active comparator | Other: (Conventional Therapy Only)Participants in this group will receive conventional physiotherapy exercises |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must meet all of the following conditions to be eligible for the study:
Key exclusion criteria (5 listed)
- Participants will be excluded if they meet any of the following conditions:
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 |
|---|---|---|
| Experimental Group (Mulligan Mobilization + Conventional Therapy)Also: SNAGs technique with conventional rehab, Lumbar SNAGs with rehabilitation exercises, Mulligan spine mobilization with physical therapy exercises, Lumbar mobilization and functional rehabilitationMulligan Sustained Natural Apophyseal Glides (SNAGs) applied to the lumbar spine, combined with conventional rehabilitation exercises (neuromuscular training, stretching, strengthening, and balance exercises). | Other | Study Group |
| (Conventional Therapy Only)Also: Conventional Physiotherapy, Standard Rehabilitation Exercises, Traditional Physiotherapy Treatment, Conventional Exercise ProgramNeuromuscular training, stretching, strengthening, balance exercises, and gait training performed without Mulligan mobilization. | Other | Control Group |
Primary outcome
Static Balance Assessment (Mini-BESTest)
Time frame: Baseline and After 4 Weeks
The Mini Balance Evaluation Systems Test (Mini-BESTest) assesses balance control, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. It consists of 14 items scored from 0 to 28, with higher scores indicating better balance.
Static Balance Assessment (ALDA Balance Device)
Time frame: Baseline and After 4 Weeks
The ALDA Balance Device uses a motion sensor placed at the L3-5 vertebrae to assess postural sway. It records movement data via a wireless system to analyze balance responses.
Dynamic Balance Assessment (Trunk Impairment Scale - TIS)
Time frame: Baseline and After 4 Weeks
The TIS assesses trunk control in stroke patients through three subcomponents: static sitting balance, dynamic sitting balance, and coordination. The scale consists of 17 items, with a total score ranging from 0 to 23, where higher scores indicate better trunk control.
Dynamic Balance Assessment (Functional Reach Test - FRT)
Time frame: Baseline and After 4 Weeks
The Functional Reach Test evaluates balance stability by measuring the maximum distance a participant can reach forward while maintaining a fixed base of support. Three trials are conducted, and the average distance is recorded. A reach distance of 15 cm or less indicates a high fall risk.
Gait Performance (Dynamic Gait Index (DGI))
Time frame: Baseline and After 4 Weeks
Assesses functional mobility and dynamic walking ability under different conditions (e.g., changing speeds, stepping over obstacles).
Gait Performance (10-Meter Walk Test)
Time frame: Baseline and After 4 Weeks
Measures gait speed by recording the time taken to walk 10 meters.
Trunk Position Sense (Proprioception) inclinometers test
Time frame: Baseline and After 4 Weeks
Inclinometers are among the most commonly used methods for measuring trunk position sense and proprioception. the participant will be guided into a 30° lumbar flexion position three times while standing and will be asked to memorize this position. Then, the participant will be instructed to close their eyes and attempt to replicate the same position. After returning to an upright stance, they will be asked to find the 30° flexion position again. This process will be repeated three times, and the results will be recorded.
3 secondary outcomes
Fall Risk (Timed Up and Go (TUG) Test)
Time frame: Baseline and After 4 Weeks
Cognitive Function (Standardized Mini Mental Test (SMMT))
Time frame: Baseline and After 4 Weeks
Functional Independence (Barthel Index)
Time frame: Baseline and After 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No. Indivudual participant data will be available to the responsible researcher.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (Mulligan Mobilization + Conventional Therapy) and (Conventional Therapy Only) in people with Balance Impairments in Stroke Patients, run by Gulhane School of Medicine 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wala'a Al-Deges, MSc (05457269342, walaa.deges@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance Assessment (Mini-BESTest) (time frame: Baseline and After 4 Weeks). The study lists 7 primary outcomes in all. 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 20 Mar 2025.