The Acute Effect of Lumbosacral Mobilization in Parkinson's Disease

NCT04524182 | Completed

• 1 other identifier: KA-19006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is a neurodegenerative disease including resting tremor, bradykinesia, rigidity and postural instability. In addition, postural disorders, motor freezing, gait disturbances, decreased arm swing and axial rotation loss accompany the disease. There is an important relationship between axial rotation and turning, which is one of many activities in daily life. Parkinson's patients with loss of axial rotation have a difficulty gait, daily living activities and is associated with falls. Classical physiotherapy methods for Parkinson's patients such as stretching, strengthening and posture exercises, balance, coordination and gait training, and different methods such as motor imagery, sensory stimuli and neurophysiological approaches can be used in the treatment of Parkinson's patients. Although there are applications that can increase axial rotation in physiotherapy programs, all programs may be able to focus adequately on the treatment of this symptom. In addition, according to the literature, the effects of all physiotherapy approaches emerge as a result of long-term training. Mobilization techniques are applications that are included in physiotherapy programs and have a wide area of use. It is divided into three subtitles according to its severity and degree: Grade A (mobilization), grade B (mobilization) and grade C (manipulation). Considering the effects of mobilization on muscle activation and balance, grade A and grade B mobilization applications are likely to increase the mobility of this area when applied on the lumbosacral region. Therefore, these practices can affect balance, gait and functional activities by regulating muscle tone (rigidity) and muscle activation and reducing axial symptoms in Parkinson's patients. Based on this information, the aim of our study is to investigate the acute effect of lumbosacral mobilization on balance, gait and functional activities in patients with Parkinson's disease.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's disease; Lumbosacral Region; Postural Balance; Gait; Manual Therapies; Activities of Daily Living

Outcome Measures

Primary Outcomes (3)

• Static Posturography Assesment (NeuroCom® Balance Master® Systems)

  It measures stability while standing statically and dynamically. The device has a computerized force platform that measures the vertical forces (center of pressure) applied on the feet of the patients to measure the position of the center of gravity and postural control. Among the parameters evaluated by the device (stability limits test, modified sensory integration and clinical assessment of balance test, sit to stand test, straight walking (walk across), standing and fast walking test (step / There are tests such as quick turn)).

  Baseline and immediately after mobilization

• Dynamic Gait Index

  It is a measurement tool that can be used to assess dynamic balance, gait, and risk for falls. Balance and walking pattern changes are scored during tasks such as changing gait speed, gait with vertical and horizontal head turns, pivot turn, step over obstacle, step around obstacles and climbing stairs. Each item of this 8-item scale is scored between 0 and 3. "0" indicates the lowest level of function and "3" the highest level of function.Total score is 24 for this scale and higher scores indicate higher level of function.

  Baseline and immediately after mobilization

• Modified Parkinson Activity Scale

  It is used to determine the limitations in daily activities. It consists of three sub-sections: chair transfer, walking akinesia and bed mobility. There are 2 items for chair transfer, 6 items for walking akinesia and 6 items for bed mobility. The scoring of each item in the scale consisting of 14 items is between 0 (dependent)-4(normal). The total score range is between 0-56. Higher scores indicate higher level of function.

  Baseline and immediately after mobilization

Secondary Outcomes (1)

• Unified Parkinson's Disease Rating Scale

  Baseline and immediately after mobilization

Other Outcomes (2)

• Mini-Mental State Examination

  Baseline

• The Modified Hoehn and Yahr Scale

  Baseline

Study Arms (2)

control group

OTHER

There was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)

Other: control group

mobilization group

EXPERIMENTAL

Lumbo-sacral mobilization was applied to the mobilization group. Lumbo-sacral mobilization techniques were applied for 10 minutes to lumbo-sacral region in the supine position. (At the end of study all patients were received home-based exercise)

Other: control group; Other: mobilization group

Interventions

control group OTHER

There was no intervention in the control group during study. At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise

control group; mobilization group

mobilization group OTHER

Lumbosacral mobilization for 10 minutes in the study group (pelvis forward and backward distraction, passive rotation of the lower body, short lever rotation, long lever rotation, lumbar central posterior-anterior, lumbar unilateral posterior-anterior, anterior rotation-posterior superior iliac spine- down, posterior rotation-posterior superior iliac spine-up were applied. At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise

mobilization group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with Idiopathic Parkinson's disease
• Being between the ages of 50-80
• Patients scoring \>24 on Standardized Mini Mental State Examination
• Modified Hoehn and Yahr stage 2-3
• No medication or dose changes during treatment
• Not participating in the physiotherapy and rehabilitation program in the last 6 months
• Volunteering to participate in the study

You may not qualify if:

• Having other neurological diseases
• Presence of postural hypotension affecting balance
• Vision problem (not compensated for with the correct lens) or presence of vestibular disorder
• Cardiopulmonary diseases affecting gait (previous history of myocardial infarction)
• Orthopedic problems that cause movement limitation and affect gait and evaluations
• Previous use of corticosteroids

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (8)

• Rana AQ, Ahmed US, Chaudry ZM, Vasan S. Parkinson's disease: a review of non-motor symptoms. Expert Rev Neurother. 2015 May;15(5):549-62. doi: 10.1586/14737175.2015.1038244.

  PMID: 25936847 BACKGROUND

• Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.

  PMID: 18344392 BACKGROUND

• Wright WG, Gurfinkel VS, Nutt J, Horak FB, Cordo PJ. Axial hypertonicity in Parkinson's disease: direct measurements of trunk and hip torque. Exp Neurol. 2007 Nov;208(1):38-46. doi: 10.1016/j.expneurol.2007.07.002. Epub 2007 Jul 17.

  PMID: 17692315 BACKGROUND

• Hong M, Earhart GM. Effects of medication on turning deficits in individuals with Parkinson's disease. J Neurol Phys Ther. 2010 Mar;34(1):11-6. doi: 10.1097/NPT.0b013e3181d070fe.

  PMID: 20212362 BACKGROUND

• Vaugoyeau M, Viallet F, Mesure S, Massion J. Coordination of axial rotation and step execution: deficits in Parkinson's disease. Gait Posture. 2003 Dec;18(3):150-7. doi: 10.1016/s0966-6362(03)00034-1.

  PMID: 14667948 BACKGROUND

• Ramaker C, Marinus J, Stiggelbout AM, Van Hilten BJ. Systematic evaluation of rating scales for impairment and disability in Parkinson's disease. Mov Disord. 2002 Sep;17(5):867-76. doi: 10.1002/mds.10248.

  PMID: 12360535 BACKGROUND

• Geldhof E, Cardon G, De Bourdeaudhuij I, Danneels L, Coorevits P, Vanderstraeten G, De Clercq D. Static and dynamic standing balance: test-retest reliability and reference values in 9 to 10 year old children. Eur J Pediatr. 2006 Nov;165(11):779-86. doi: 10.1007/s00431-006-0173-5.

  PMID: 16738867 BACKGROUND

• Keus SH, Nieuwboer A, Bloem BR, Borm GF, Munneke M. Clinimetric analyses of the Modified Parkinson Activity Scale. Parkinsonism Relat Disord. 2009 May;15(4):263-9. doi: 10.1016/j.parkreldis.2008.06.003. Epub 2008 Aug 8.

  PMID: 18691929 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Büşra Seçkinoğulları, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ayla Fil Balkan, Assoc. Prof

  Hacettepe University

  STUDY CHAIR

• Bülent Elibol, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

• Gül Yalçın Çakmaklı, Assoc. Prof

  Hacettepe University

  STUDY DIRECTOR

• Songül Aksoy, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: randomized controlled

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)