- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06887114
Can Lumbar Mulligan Mobilization Improve Gait, Balance, and Trunk Position Sense After Stroke?
Effects of Mulligan-Based Lumbar Mobilization on Trunk Position Sense, Balance, and Gait in Stroke Survivors: A Randomized Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wala'a Al-Deges, MSc
- Phone Number: 05457269342
- Email: walaa.deges@yahoo.com
Study Locations
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Ankara, Turkey, 06010
- Recruiting
- Ankara Yıldırım Beyazıt University
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Contact:
- Wala'a AlDEGES, Mac
- Phone Number: 05457269342
- Email: walaa.deges@yahoo.com
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Contact:
- Wala'a Al-deges, MSc
- Phone Number: 05457269342
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Principal Investigator:
- Wala'a AlDEGES
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Group
Participants in this group will receive a combination of Mulligan Sustained Natural Apophyseal Glides (SNAGs) and conventional exercises.
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Mulligan Sustained Natural Apophyseal Glides (SNAGs) applied to the lumbar spine, combined with conventional rehabilitation exercises (neuromuscular training, stretching, strengthening, and balance exercises).
Other Names:
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Active Comparator: Control Group
Participants in this group will receive conventional physiotherapy exercises
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Neuromuscular training, stretching, strengthening, balance exercises, and gait training performed without Mulligan mobilization.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Static Balance Assessment (Mini-BESTest)
Time Frame: Baseline and After 4 Weeks
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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.
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Baseline and After 4 Weeks
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Static Balance Assessment (ALDA Balance Device)
Time Frame: Baseline and After 4 Weeks
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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.
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Baseline and After 4 Weeks
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Dynamic Balance Assessment (Trunk Impairment Scale - TIS)
Time Frame: Baseline and After 4 Weeks
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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.
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Baseline and After 4 Weeks
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Dynamic Balance Assessment (Functional Reach Test - FRT)
Time Frame: Baseline and After 4 Weeks
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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.
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Baseline and After 4 Weeks
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Gait Performance (Dynamic Gait Index (DGI))
Time Frame: Baseline and After 4 Weeks
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Assesses functional mobility and dynamic walking ability under different conditions (e.g., changing speeds, stepping over obstacles).
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Baseline and After 4 Weeks
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Gait Performance (10-Meter Walk Test)
Time Frame: Baseline and After 4 Weeks
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Measures gait speed by recording the time taken to walk 10 meters.
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Baseline and After 4 Weeks
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Trunk Position Sense (Proprioception) inclinometers test
Time Frame: Baseline and After 4 Weeks
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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.
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Baseline and After 4 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Risk (Timed Up and Go (TUG) Test)
Time Frame: Baseline and After 4 Weeks
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Evaluates functional mobility by measuring the time taken to stand from a chair, walk 3 meters, turn, walk back, and sit down.
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Baseline and After 4 Weeks
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Cognitive Function (Standardized Mini Mental Test (SMMT))
Time Frame: Baseline and After 4 Weeks
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Assesses cognitive status, including memory, attention, and visuospatial abilities.
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Baseline and After 4 Weeks
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Functional Independence (Barthel Index)
Time Frame: Baseline and After 4 Weeks
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Assesses independence in daily living activities such as mobility, self-care, and transfers.
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Baseline and After 4 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 14.03.2024/02-592
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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