Parkinson DiseaseNCT05350709
Action Observation Therapy and Mirror Therapy in Parkinson's Disease
A study testing mirror therapy in people with Parkinson Disease and Tremor, run by Kirsehir Ahi Evran Universitesi.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Tremor
- What is being tested?
- mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Parkinson Disease, Tremor
- Being tested
- mirror therapy
- Keywords
- mirror therapy, action observation therapy
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyOther
Also called action observational therapy, conventional therapy
15 patients will be recruited to each group. Patients will receive a total of 20 sessions of treatment, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| mirror therapy | Active comparator | 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. Receives: Other: mirror therapy |
| action observational therapy | Active comparator | 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. Receives: Other: mirror therapy |
| conventional therapy | Active comparator | 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. Receives: Other: mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start25 Apr 2022 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmanur Aybala KOÇAK, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350709
- Sponsor's protocol ID
- 2022-02/02
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27563470Temporiti 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.
PubMed 32903559Carod-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.
PubMed 17516479
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05350709
- Acronym / sponsor ID
- 2022-02/02
- Conditions
- Parkinson Disease, Tremor
- Keywords
- mirror therapy, action observation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mirror therapy | Active comparator | Other: mirror therapyAn 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. |
| action observational therapy | Active comparator | Other: mirror therapyAn 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 | Active comparator | Other: mirror therapyConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirror therapyAlso: action observational therapy, conventional therapy15 patients will be recruited to each group. Patients will receive a total of 20 sessions of treatment, 5 days a week. | Other | action observational therapy, conventional therapy, mirror therapy |
Primary outcome
improvement in hand functions
Time frame: 3 months
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.
5 secondary outcomes
Hand and Finger Grip Strength
Time frame: 3 months
quality of life
Time frame: 3 months
dexterity
Time frame: 3 months
dexterity
Time frame: 3 months
dexterity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 27563470Bonassi 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.
- Background: PubMed 32903559Temporiti 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.
- Background: PubMed 17516479Carod-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy in people with Parkinson Disease and Tremor, run by Kirsehir Ahi Evran Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatmanur Aybala Kocak, assoc. prof. (5052470739 ext. +90, faybalarem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in hand functions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350709, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.