The Acute Effect of Lumbosacral Mobilization in Parkinson's Disease

NCT ID: NCT04524182

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Parkinson's disease is a neurodegenerative disease defined by James Parkinson in 1817, resulting from the progressive loss of dopaminergic neurons in the basal ganglion and substantia nigra. The four main motor signs of the disease are 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. Turning is a complex action that involves head and trunk rotation in the transverse plane. En bloc turning occurs with the decrease of inter-segment coordination in Parkinson's patients with loss of axial rotation, which refers to the almost simultaneous rotation of the head, trunk and pelvis. This problem affects a large percentage of people with Parkinson's disease, hinders daily living activities, is associated with falls, and has a significant impact on quality of life. Losses in axial rotation also can affect properties of gait such as speed and stride length.

Physiotherapy is effective in improving gait, balance and functional activities in Parkinson's patients. Classical physiotherapy methods 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). Grade A (mobilization) is active, active-assisted or passive mobilization in the spinal joints within the painless range of motion. It is generally applied in the middle range in spinal joints. It is especially preferred in the treatment of acute, irritable spinal lesions. Grade B (mobilization) refers to mobilization in the form of continuous stretching at the end of the range of motion in the spinal joints. Grade C (manipulation) is a minimal amplitude high velocity passive pushing motion performed at the end of the joint range of motion.

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

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type OTHER

control group

Intervention Type 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

mobilization group

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)

Group Type EXPERIMENTAL

control group

Intervention Type 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

mobilization group

Intervention Type 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

Interventions

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control group

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

Intervention Type OTHER

mobilization group

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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ayla fil balkan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Büşra Seçkinoğulları, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ayla Fil Balkan, Assoc. Prof

Role: STUDY_CHAIR

Hacettepe University

Bülent Elibol, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Gül Yalçın Çakmaklı, Assoc. Prof

Role: STUDY_DIRECTOR

Hacettepe University

Songül Aksoy, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25936847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18344392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17692315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20212362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14667948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12360535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16738867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18691929 (View on PubMed)

Other Identifiers

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KA-19006

Identifier Type: -

Identifier Source: org_study_id