search
Back to results

Action Observation Therapy and Mirror Therapy in Parkinson's Disease

Primary Purpose

Parkinson Disease, Tremor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mirror therapy
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring mirror therapy, action observation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18 years and older,
  2. Diagnosed with idiopathic Parkinson's disease,
  3. Parkinson's disease stage (patients with Hoehn Yahr≤3)
  4. Patients who can hear and follow verbal instructions.

Exclusion Criteria:

  1. Patients who cannot cooperate,
  2. Patients with dementia or comorbidities affecting cognitive functions,
  3. Patients with serious comorbidities (such as decompensated heart failure, decompensated kidney failure) and significant disability (such as vision loss, hearing loss) affecting functionality,
  4. Patients with another disease (such as inflammatory diseases, polyneuropathy, brachial plexus lesion, loss of range of motion after trauma) affecting upper extremity functions.
  5. Patients diagnosed with secondary Parkinson's disease
  6. Patients with acute neurological disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    mirror therapy

    action observational therapy

    conventional therapy

    Arm Description

    An exercise program has been prepared for patients for use in mirror therapy. In this exercise program, firstly, joint movements of the hand and fingers (opening and closing the fingers one by one, making a fist, moving the hand to the right and left, turning the wrist) are shown. Then, activities with some small objects used in daily life (squeezing ball, putting clothespins, collecting paper clips from the table, using tongs, turning cards, turning pages) is shown. The patient will repeat the movement for 3 minutes. The patient will hold the affected extremity behind the mirror with the healthy extremity, the patient will look towards the affected side from the mirror and try to do the movements with the affected extremity. . The treatment period will be 20 sessions, 5 days a week, for 4 weeks.The exercises will take 1 hour, including half an hour of mirror therapy and half an hour of conventional exercises.

    An exercise video has been prepared for the patients to watch for the action observation therapy. In this video, first of all, joint movements of the hand and fingers (opening and closing the fingers one by one, making a fist, moving the hand to the right and left, turning the wrist, etc.) are shown. Then, activities with some small objects used in daily life (squeezing ball, putting clothespins, collecting paper clips from the table, using tongs, turning cards, turning pages, etc.). is shown. The patient will first watch the video of each movement, and then repeat the movement for 3 minutes. The treatment period will be 5 days a week, a total of 20 sessions for 4 weeks.The exercises will take 1 hour, including half an hour of action observational therapy and half an hour of conventional exercises.

    Conventional therapy includes range of motion exercises, walking and balance exercises. The treatment period will be 5 days a week, a total of 20 sessions for 4 weeks. The exercises will last for half an hour daily.

    Outcomes

    Primary Outcome Measures

    improvement in hand functions
    The Movement Disorder Society-Sponsored Revision of the Unified, which is used to evaluate the symptoms and signs of Parkinson's Disease, consists of a total of 4 chapters and 42 items. Each item is scored between 0 (normal) and 4 (most severe). The scores obtained are evaluated as a percentage. As the total score increases, it is understood that the mental status for the first part and the functional status for the other parts are worse. In this study, the motor part of the evaluation scale will be used. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the results of the scale (The Movement Disorder Society-Sponsored Revision of the Unified) evaluating the improvement in hand functions will be evaluated.

    Secondary Outcome Measures

    Hand and Finger Grip Strength
    Hand rough grip strength will be measured with a Jamar hydraulic hand dynamometer. A pinchmeter will be used for lateral, tip and triple grip measurement. The Jamar dynamometer has five stages. Measurements will be made in the position of the jamar suitable for the hand size of the patients, in the dominant extremity, with the patients in an upright position, shoulder adduction, elbow 90 degrees flexion, anterior colmidrotation and wrist 30 degrees extension, and maximum voluntary grasping will be requested from the patients. Measurements will be made 3 times and the average value will be recorded in kilograms. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the Hand and Finger Grip Strength will be evaluated.
    quality of life
    Parkinson's Disease questionnaire; It consists of eight sections and thirty-nine questions: mobility 10 questions, activities of daily living 6 questions, stigma 4 questions, emotional status 6 questions, cognition 4 questions, social support 3 questions, physical discomfort 3 questions, communication 3 questions. Each question is scored between 0 and 4. It is expressed as '0 never, 1 rarely, 2 sometimes, 3 often, 4 always'. The total value obtained is converted into points between 0-100. A low score indicates a good quality of life, and a high score indicates a poor quality of life. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the results of the scale (Parkinson's Disease questionnaire) evaluating the quality of life will be evaluated.
    dexterity
    Nine-hole peg test will be used for the evaluation of hand dexterity. Nine-hole peg test consists of nine small sticks and a board with nine holes on which these sticks can be placed. Patients will be asked to sit at the table and insert the sticks into the holes one by one as quickly as possible, and then collect them again. The elapsed time will be measured with recorded in seconds. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.
    dexterity
    Minnesota Manual Dexterity test will be used for the evaluation of hand dexterity. The test consisted of 20 movable discs that could go from one hole to another. Removing, turning and placing the discs from the cavities was performed bilaterally in the right and left upper extremities, and the result was recorded in 'seconds'. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.
    dexterity
    Box and block test will be used for the evaluation of hand dexterity. In the box and block test, there are 150 cubes in total in a box with a two-sided compartment. The cubes are 2.5 cm. edged. The patient is asked to move the cubes from one compartment to the other compartment one by one. The number of cubes carried in 60 seconds gives the test score. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.

    Full Information

    First Posted
    April 18, 2022
    Last Updated
    April 22, 2022
    Sponsor
    Kirsehir Ahi Evran Universitesi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05350709
    Brief Title
    Action Observation Therapy and Mirror Therapy in Parkinson's Disease
    Official Title
    Comparison of the Effectiveness of Action Observation Therapy and Mirror Therapy on Upper Extremity Functions and Quality of Life in Patients With Parkinson's Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 25, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    October 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kirsehir Ahi Evran Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Small muscles of the hand are affected due to involuntary movements and slowing of voluntary movements seen in Parkinson's disease. There is a loss of fine dexterity and coordination in the hand. It becomes difficult for patients to grasp and release of the objects. They become unable to perform daily activities such as buttoning up, holding keys, brushing teeth, holding forks, spoons and glasses, and writing. Therefore, a certain part of the rehabilitation program should be devoted to upper extremity rehabilitation. The aim of this study was to compare the effects of action observation therapy and mirror therapy, which have been used in the literature for many years, on upper extremity functions and quality of life in individuals with Parkinson's disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Tremor
    Keywords
    mirror therapy, action observation therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    via closed envelopes
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mirror therapy
    Arm Type
    Active Comparator
    Arm Description
    An exercise program has been prepared for patients for use in mirror therapy. In this exercise program, firstly, joint movements of the hand and fingers (opening and closing the fingers one by one, making a fist, moving the hand to the right and left, turning the wrist) are shown. Then, activities with some small objects used in daily life (squeezing ball, putting clothespins, collecting paper clips from the table, using tongs, turning cards, turning pages) is shown. The patient will repeat the movement for 3 minutes. The patient will hold the affected extremity behind the mirror with the healthy extremity, the patient will look towards the affected side from the mirror and try to do the movements with the affected extremity. . The treatment period will be 20 sessions, 5 days a week, for 4 weeks.The exercises will take 1 hour, including half an hour of mirror therapy and half an hour of conventional exercises.
    Arm Title
    action observational therapy
    Arm Type
    Active Comparator
    Arm Description
    An exercise video has been prepared for the patients to watch for the action observation therapy. In this video, first of all, joint movements of the hand and fingers (opening and closing the fingers one by one, making a fist, moving the hand to the right and left, turning the wrist, etc.) are shown. Then, activities with some small objects used in daily life (squeezing ball, putting clothespins, collecting paper clips from the table, using tongs, turning cards, turning pages, etc.). is shown. The patient will first watch the video of each movement, and then repeat the movement for 3 minutes. The treatment period will be 5 days a week, a total of 20 sessions for 4 weeks.The exercises will take 1 hour, including half an hour of action observational therapy and half an hour of conventional exercises.
    Arm Title
    conventional therapy
    Arm Type
    Active Comparator
    Arm Description
    Conventional therapy includes range of motion exercises, walking and balance exercises. The treatment period will be 5 days a week, a total of 20 sessions for 4 weeks. The exercises will last for half an hour daily.
    Intervention Type
    Other
    Intervention Name(s)
    mirror therapy
    Other Intervention Name(s)
    action observational therapy, conventional therapy
    Intervention Description
    15 patients will be recruited to each group. Patients will receive a total of 20 sessions of treatment, 5 days a week.
    Primary Outcome Measure Information:
    Title
    improvement in hand functions
    Description
    The Movement Disorder Society-Sponsored Revision of the Unified, which is used to evaluate the symptoms and signs of Parkinson's Disease, consists of a total of 4 chapters and 42 items. Each item is scored between 0 (normal) and 4 (most severe). The scores obtained are evaluated as a percentage. As the total score increases, it is understood that the mental status for the first part and the functional status for the other parts are worse. In this study, the motor part of the evaluation scale will be used. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the results of the scale (The Movement Disorder Society-Sponsored Revision of the Unified) evaluating the improvement in hand functions will be evaluated.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Hand and Finger Grip Strength
    Description
    Hand rough grip strength will be measured with a Jamar hydraulic hand dynamometer. A pinchmeter will be used for lateral, tip and triple grip measurement. The Jamar dynamometer has five stages. Measurements will be made in the position of the jamar suitable for the hand size of the patients, in the dominant extremity, with the patients in an upright position, shoulder adduction, elbow 90 degrees flexion, anterior colmidrotation and wrist 30 degrees extension, and maximum voluntary grasping will be requested from the patients. Measurements will be made 3 times and the average value will be recorded in kilograms. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the Hand and Finger Grip Strength will be evaluated.
    Time Frame
    3 months
    Title
    quality of life
    Description
    Parkinson's Disease questionnaire; It consists of eight sections and thirty-nine questions: mobility 10 questions, activities of daily living 6 questions, stigma 4 questions, emotional status 6 questions, cognition 4 questions, social support 3 questions, physical discomfort 3 questions, communication 3 questions. Each question is scored between 0 and 4. It is expressed as '0 never, 1 rarely, 2 sometimes, 3 often, 4 always'. The total value obtained is converted into points between 0-100. A low score indicates a good quality of life, and a high score indicates a poor quality of life. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the results of the scale (Parkinson's Disease questionnaire) evaluating the quality of life will be evaluated.
    Time Frame
    3 months
    Title
    dexterity
    Description
    Nine-hole peg test will be used for the evaluation of hand dexterity. Nine-hole peg test consists of nine small sticks and a board with nine holes on which these sticks can be placed. Patients will be asked to sit at the table and insert the sticks into the holes one by one as quickly as possible, and then collect them again. The elapsed time will be measured with recorded in seconds. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.
    Time Frame
    3 months
    Title
    dexterity
    Description
    Minnesota Manual Dexterity test will be used for the evaluation of hand dexterity. The test consisted of 20 movable discs that could go from one hole to another. Removing, turning and placing the discs from the cavities was performed bilaterally in the right and left upper extremities, and the result was recorded in 'seconds'. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.
    Time Frame
    3 months
    Title
    dexterity
    Description
    Box and block test will be used for the evaluation of hand dexterity. In the box and block test, there are 150 cubes in total in a box with a two-sided compartment. The cubes are 2.5 cm. edged. The patient is asked to move the cubes from one compartment to the other compartment one by one. The number of cubes carried in 60 seconds gives the test score. The patients will be evaluated three times. Once in the beginning (before the study), second evaluation will be made in the 1st month after the treatment and the 3rd month after the treatment the 3rd evaluation will be made. The change in the hand dexterity will be evaluated.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years and older, Diagnosed with idiopathic Parkinson's disease, Parkinson's disease stage (patients with Hoehn Yahr≤3) Patients who can hear and follow verbal instructions. Exclusion Criteria: Patients who cannot cooperate, Patients with dementia or comorbidities affecting cognitive functions, Patients with serious comorbidities (such as decompensated heart failure, decompensated kidney failure) and significant disability (such as vision loss, hearing loss) affecting functionality, Patients with another disease (such as inflammatory diseases, polyneuropathy, brachial plexus lesion, loss of range of motion after trauma) affecting upper extremity functions. Patients diagnosed with secondary Parkinson's disease Patients with acute neurological disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatmanur Aybala Kocak, assoc. prof.
    Phone
    5052470739
    Ext
    +90
    Email
    faybalarem@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hakan Hatırlı, resident
    Phone
    5386461474
    Ext
    +90
    Email
    hakanhatirli@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27563470
    Citation
    Bonassi G, Pelosin E, Ogliastro C, Cerulli C, Abbruzzese G, Avanzino L. Mirror Visual Feedback to Improve Bradykinesia in Parkinson's Disease. Neural Plast. 2016;2016:8764238. doi: 10.1155/2016/8764238. Epub 2016 Aug 1.
    Results Reference
    background
    PubMed Identifier
    32903559
    Citation
    Temporiti F, Adamo P, Cavalli E, Gatti R. Efficacy and Characteristics of the Stimuli of Action Observation Therapy in Subjects With Parkinson's Disease: A Systematic Review. Front Neurol. 2020 Aug 13;11:808. doi: 10.3389/fneur.2020.00808. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    17516479
    Citation
    Carod-Artal FJ, Vargas AP, Martinez-Martin P. Determinants of quality of life in Brazilian patients with Parkinson's disease. Mov Disord. 2007 Jul 30;22(10):1408-1415. doi: 10.1002/mds.21408.
    Results Reference
    background

    Learn more about this trial

    Action Observation Therapy and Mirror Therapy in Parkinson's Disease

    We'll reach out to this number within 24 hrs