NCT05241015

Brief Summary

There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in PD. In PD, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. Numerous studies show that the main source of motor problems in PD is dysfunction of sensorimotor integration. Since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. Therefore, sensorimotor training targeting the cervical region gains importance. In this study, we aim to reduce PD-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. Patients with Parkinson's disease will be included in the study and randomly divided into 2 groups. While the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

January 7, 2022

Last Update Submit

February 20, 2024

Conditions

Keywords

ParkinsonUpper ExtremitySensorimotor TrainingICFFunction

Outcome Measures

Primary Outcomes (18)

  • Posture Analysis

    New York Posture Rating Chart

    Change from baseline at 8 week

  • Tremor

    Fahn; Tolosa, Marin Clinical Tremor Rating Scale will be used to evaluate tremor. Each item was scored between 0-4. A lower score is an indicator of better status.

    Change from baseline at 8 week

  • Unified Parkinson's Disease Rating Scale

    Unified Parkinson's Disease Rating Scale is a scale that evaluates disability and disorders related to Parkinson's and consists of 4 main subtitles and 42 questions in total . Each item was scored between 0-4 . A lower score is an indicator of better status.

    Change from baseline at 8 week

  • Proprioception

    For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.

    Change from baseline at 8 week

  • Tactile acuity

    For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.

    Change from baseline at 8 week

  • Touch threshold

    Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.

    Change from baseline at 8 week

  • Pain threshold

    Algometer will be used to evaluate upper extremity pain threshold.

    Change from baseline at 8 week

  • Pain intensity

    Visual pain scale (VAS) will be used to evaluate upper extremity pain.In the evaluation, pain averages ranging from 0 to 10 cm are given. "0" indicates that there is no pain, while as the score increases, the severity of pain increases.

    Change from baseline at 8 week

  • Hand Grip Strength

    Hand Dynamometer will be used to measure hand grip strength.

    Change from baseline at 8 week

  • Pinch Grip Strength

    Pinch meter will be used to measure pinch grip strength.

    Change from baseline at 8 week

  • Endurance of Cervical Muscles

    Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles

    Change from baseline at 8 week

  • Fatigue

    Parkinson's Fatigue Scale will be used to evaluate fatigue. It is consists of 16 items related to presence of fatigue. All items are scored by patients using a five-point Likert-type scale including response options ranging from '(1) strongly disagree' to '(5) strongly agree'. A higher score indicates a higher level of fatigue.

    Change from baseline at 8 week

  • Hand functions

    Purdue Pegboard Test (PPT)

    Change from baseline at 8 week

  • Dual Task Performance

    During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.

    Change from baseline at 8 week

  • Disabilities of the Arm, Shoulder and Hand Questionnaire

    It will be used to determine the problems experienced in the use of the upper extremity. It consists of 3 sections. All questions are answered according to a 5-point Likert system. A score between 0-100 is obtained from each section. The higher the score, the higher the disability.

    Change from baseline at 8 week

  • Quality of life evaluation

    Parkinson's Disease Questionnaire (PDQ-39) will be used to evaluate quality of life. It contains 39 items in total. A score between 0 and 4 is given for each question. A high overall score indicates worsening quality of life.

    Change from baseline at 8 week

  • Evaluation of Environmental Factors

    Questions structured by the researchers will be used on the issues of support and attitudes under the environmental factors heading of the ICF model. Questions are scored between 0 and 10. A high score indicates high satisfaction.

    Change from baseline at 8 week

  • Motor speed

    Motor speed will be evaluated using the Finger tapping test.

    Change from baseline at 8 week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks.

Other: Control Group

Exercises Group

EXPERIMENTAL

In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.

Other: Exercises Group

Interventions

Treatment protocol; It will be applied to improve posture, strengthen muscles, eliminate shortness, increase flexibility, balance/coordination, sit up/stand up and in-bed mobilization, and improve gait. Before taking the treatment, a general evaluation will be made and as a result of this evaluation, muscle shortness, loss of strength, postural disorders and the activities and positions they have the most difficulty in daily life will be determined. Treatment programs will be shaped according to the problems determined in line with the evaluations made.

Control Group

In addition to the standard physiotherapy program, sensorimotor training including the cervical region will be given to the this group. Deep cervical flexor and extensor muscles, which provide stability in the cervical region, will be trained. A Pressure Biofeedback Device will be used to train the deep cervical flexors. Both positional and kinesthetic sensory training will be provided by maintaining the stability of the cervical region by means of the laser kit that provides visual feedback.Additionally, oculomotor exercises will be given.

Exercises Group

Eligibility Criteria

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

You may qualify if:

  • Having idiopathic Parkinson's disease over the age of 40
  • Meets the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank
  • Hoehn-Yahr Staging \<3
  • Mini mental test score of 24 and above
  • In the "on" period
  • Receiving oral therapy only

You may not qualify if:

  • Patients receiving device-assisted therapy
  • Patients receiving apomorphine therapy
  • Patients with mini mental test scores below 24
  • Patients who use drugs (antidepressants, etc.) that will affect cognitive functions
  • Patients with hearing and speech problems
  • Patients with orthopedic, neurological and vestibular problems other than Parkinson's that may prevent them from completing the tests and treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Principal Investigator

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 15, 2022

Study Start

December 8, 2021

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations