NCT03854747

Brief Summary

Parkinson's disease (PH); it occurs due to dopamine deficiency due to the loss of dopaminergic neurons in a degenerative process in the substantia nigra found in the middle brain; resting tremor, bradykinesia, trunk and extremities rigidity, mask facial and postural instability characterized by a neurodegenerative disease. These findings are basic and also motor symptoms of Parkinson's Disease. Non-motor symptoms include many problems ranging from autonomic dysfunction to sensory symptoms. Treatment of Parkinson's disease requires a multidisciplinary approach such as medical treatment, physiotherapy and rehabilitation, surgical treatment. Physiotherapy programs applied to patients with Parkinson's disease include classical physiotherapy methods and neurophysiological based methods. Spinal stabilization is an important concept for proper control of body balance and extremity movements. Spinal stabilization training was based on biomechanics, neurophysiology and physiotherapy research. Stabilization exercises, which form the basis of spinal stabilization training, increase the strength and endurance of the postural and stabilizing muscles using the basic principles of motor learning and improve stability control in stable and unstable positions, provides postural smoothness. The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Although studies have been carried out to investigate the effect of spinal stabilization exercises in Parkinson's patients, there is no study on the effect of cervical region stabilization exercises in the literature despite these important connections of the cervical region. For these reasons, this study is planned to investigate the effects of cervical spinal stabilization exercises on spinal posture, cervical proprioception and postural instability in Parkinson's patients. Hypothesis 1: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, it will be more effective in correcting spinal posture. Hypothesis 2: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, cervical proprioception will develop better. Hypothesis 3: In the case of Parkinson's patients, when the cervical spinal stabilization exercises are added to the traditional physiotherapy program, postural stability may be more pronounced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

February 16, 2019

Last Update Submit

October 18, 2021

Conditions

Outcome Measures

Primary Outcomes (16)

  • Static Posturography

    balance measurement (Number of Participants estimated 20 individuals)

    baseline to 8 week after

  • X-Ray Measure

    scoliosis graphy

    baseline to 8 week after

  • Bubble Inclinometer

    measurement of spine curvature angle (Number of Participants estimated 20 individuals)

    baseline to 8 week after

  • Scoliometer

    measurement of spine curvature angle

    baseline to 8 week after

  • UPDRS

    Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.

    baseline to 8 week after

  • Berg Balance Scale

    balance measurement. It is a 14-item balance scale. The range of points is between 0 and 56. The total score is calculated by summing the points of each item. high score good balance, low score indicates bad balance.

    baseline to 8 week after

  • Posture Analyse

    is a scale that evaluates the participant's 13 different regions from posterior and lateral to postural disorder. the scoring of each region is 1-3-5. if normal is 5 points, moderate level is 3 points, if there is any advanced disorder 1 point is given. the total score is determined by summing all the values. total maximum 65, minimum 13 points. high score good posture, low score indicates bad posture

    baseline to 8 week after

  • Cervical Proprioception

    A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device

    baseline to 8 week after

  • Visual Analog Scale

    Visual Analog Scala. Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. the participant is asked to say a value in this range according to the severity of pain.

    baseline to 8 week after

  • 10 meter walk test

    walking speed calculation

    baseline to 8 week after

  • Timed Get up and Walk Test

    walking time and cadence calculation

    baseline to 8 week after

  • Cervical Ventral Endurance Evaluation

    Endurance evaluation will be done to deep cervical flexor extensor muscles

    baseline to 8 week after

  • Muscle Strength Assessment

    evaluation of the strength of the muscles in the cervical region and shoulder circumference

    baseline to 8 week after

  • Evaluation of Muscle Shortness

    measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure

    baseline to 8 week after

  • Normal Joint Movement Assessment

    measurement of normal range of motion

    baseline to 8 week after

  • Short Form-36

    SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.

    baseline to 8 week after

Study Arms (2)

control group

NO INTERVENTION

working group

EXPERIMENTAL
Other: cervical spinal stabilization exercise

Interventions

The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.

working group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic Parkinson's disease,
  • Having planned a traditional physiotherapy program for Parkinson's disease and referring to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department,
  • to 80 years old,
  • According to Hoehn-Yahr scale to be in stage 2 or 3,
  • Having scored 30 points above the posture evaluation
  • Postural disorder in the femoral region, but the absence of structural disorder (congenital spinal deformities in medical evaluations prior to the study, structural disorders caused by other diseases should be determined that the spine does not have problems),
  • points higher than the mini-mental test,
  • Disease duration is 3 years and above,
  • The absence of any other neurological disease other than vestibular and / or Parkinson's, which may affect muscle strength, balance and coordination,
  • Spinal colon and lower extremity musculoskeletal system, which may affect the stabilization of any surgery has been identified as.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

  • Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.

    PMID: 22895940BACKGROUND
  • 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: 18344392BACKGROUND
  • Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.

    PMID: 19711119BACKGROUND
  • Shujaat F, Soomro N, Khan M. The effectiveness of Kayaking exercises as compared to general mobility exercises in reducing axial rigidity and improve bed mobility in early to mid stage of Parkinson's disease. Pak J Med Sci. 2014 Sep;30(5):1094-8. doi: 10.12669/pjms.305.5231.

    PMID: 25225533BACKGROUND
  • Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.

    PMID: 16686575BACKGROUND
  • Kaya DO, Ergun N, Hayran M. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial. J Back Musculoskelet Rehabil. 2012;25(2):109-16. doi: 10.3233/BMR-2012-0318.

    PMID: 22684202BACKGROUND
  • Demircan EN, Kose N, Cakmakli GY, Aksoy S, Gocmen R, Zengin HY, Elibol B. Do cervical stabilization exercises change the effects of conventional exercises in patients with Parkinson's disease? Neurol Res. 2023 Oct;45(10):936-946. doi: 10.1080/01616412.2023.2249699. Epub 2023 Aug 22.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phsiotherapist

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 26, 2019

Study Start

March 4, 2019

Primary Completion

July 26, 2019

Study Completion

August 2, 2019

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations