NCT05350709

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable parkinson-disease

Status
unknown

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

April 18, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 18, 2022

Last Update Submit

April 22, 2022

Conditions

Keywords

mirror therapyaction observation therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Hand and Finger Grip Strength

    3 months

  • quality of life

    3 months

  • dexterity

    3 months

  • dexterity

    3 months

  • dexterity

    3 months

Study Arms (3)

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.

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.

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.

Other: mirror therapy

Interventions

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

Also known as: action observational therapy, conventional therapy
action observational therapyconventional therapymirror therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 27563470BACKGROUND
  • 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.

    PMID: 32903559BACKGROUND
  • 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.

    PMID: 17516479BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseTremor

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Central Study Contacts

Fatmanur Aybala Kocak, assoc. prof.

CONTACT

Hakan Hatırlı, resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
via closed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Physical Medicine and Rehabilitation Specialist, Principal Investigator, Associate Professor

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 28, 2022

Study Start

April 25, 2022

Primary Completion

September 15, 2022

Study Completion

October 15, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04