Can Lumbar Mulligan Mobilization Improve Gait, Balance, and Trunk Position Sense After Stroke?

NCT06887114 | Recruiting

• 1 other identifier: 14.03.2024/02-592
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Balance Impairments in Stroke Patients

Keywords

Stroke, Lumbar Mobilization, Mulligan, Balance, Trunk Position Sense and Gait.

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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).

  Baseline and After 4 Weeks

• Gait Performance (10-Meter Walk Test)

  Measures gait speed by recording the time taken to walk 10 meters.

  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.

  Baseline and After 4 Weeks

Secondary Outcomes (3)

• Fall Risk (Timed Up and Go (TUG) Test)

  Baseline and After 4 Weeks

• Cognitive Function (Standardized Mini Mental Test (SMMT))

  Baseline and After 4 Weeks

• Functional Independence (Barthel Index)

  Baseline and After 4 Weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Participants in this group will receive a combination of Mulligan Sustained Natural Apophyseal Glides (SNAGs) and conventional exercises.

Other: Experimental Group (Mulligan Mobilization + Conventional Therapy)

Control Group

ACTIVE COMPARATOR

Participants in this group will receive conventional physiotherapy exercises

Other: (Conventional Therapy Only)

Interventions

Experimental Group (Mulligan Mobilization + Conventional Therapy) OTHER

Mulligan Sustained Natural Apophyseal Glides (SNAGs) applied to the lumbar spine, combined with conventional rehabilitation exercises (neuromuscular training, stretching, strengthening, and balance exercises).

Also known as: SNAGs technique with conventional rehab, Lumbar SNAGs with rehabilitation exercises, Mulligan spine mobilization with physical therapy exercises, Lumbar mobilization and functional rehabilitation

Study Group

(Conventional Therapy Only) OTHER

Neuromuscular training, stretching, strengthening, balance exercises, and gait training performed without Mulligan mobilization.

Also known as: Conventional Physiotherapy, Standard Rehabilitation Exercises, Traditional Physiotherapy Treatment, Conventional Exercise Program, Conventional Physiotherapy with Balance and Strengthening Exercises

Control Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Wala'a Al-Deges, MSc

CONTACT

05457269342; walaa.deges@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Outcomes Assessor) single (outcomes assessor) single (outcomes assessor) the evaulation of the patients will be carried out by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocc. Prof.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: May 8, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)