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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05350709
Other study ID # 2022-02/02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date October 15, 2022

Study information

Verified date April 2022
Source Kirsehir Ahi Evran Universitesi
Contact Fatmanur Aybala Kocak, assoc. prof.
Phone 5052470739
Email faybalarem@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date October 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
mirror therapy
15 patients will be recruited to each group. Patients will receive a total of 20 sessions of treatment, 5 days a week.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary 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.
3 months
Secondary 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.
3 months
Secondary 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.
3 months
Secondary 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.
3 months
Secondary 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.
3 months
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