Investigating the effectiveness of visual, auditory and vibrational feedbacks in improving movement disorders in patients with Parkinson's disease
Design
Clinical trial without control group, blinding and randomization did not take place. On 25 patients.
Settings and conduct
in the neurology clinic of Ghaem Hospital and the personal neurology office
Participants/Inclusion and exclusion criteria
patients with an age range of 40 to 80 years has idiopathic Parkinson's diagnosed by a neurologist and has Freezing of gait movement dry movement disorder Grade 2 (occasional dry movement when walking) or grade 3 (frequently walking dry movement and occasionally falling after it) and has acceptable hearing and vision ; Patients with acute movement disorders or other neurological and physical disorders, vision, hearing and heart problems
Intervention groups
Parkinsonian patients
Interventions include the use of visual, auditory, and vibrational feedbacks
Main outcome variables
1- Walking speed (meters per second)
2-The average step length in a certain interval (cm)
3-the number of steps per minute
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240104060608N1
Registration date:2024-05-04, 1403/02/15
Registration timing:prospective
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Amir Ata Mashreghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 3564
Email address
amiratamashreghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of three cueing devices (visual, auditory, and vibration) for people with Parkinson’s disease with freezing of gait difficulties
Public title
Effect of three cueing devices (visual, auditory, and vibration) for people with Parkinson’s disease with freezing of gait difficulties
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with an age range of 40 to 80 years with idiopathic Parkinson's diagnosed by a neurologist
Has dry movement disorder-Freezing of gait-movements Grade 2 (occasional dry movement when walking) or grade 3 (frequently walking dry movement and occasionally falling after it)
Acceptable vision and hearing
Exclusion criteria:
Patients with acute movement disorders or other neurological and physical disorders, vision, hearing and heart problems
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 63, 3rd Yas Ave.,Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9186645745
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.MUMS.REC.1402.235
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Walking speed (velocity)
Timepoint
day 1 and 8
Method of measurement
meters per seconds
2
Description
stride length
Timepoint
day1 and 8
Method of measurement
steps per distance
3
Description
cadence
Timepoint
day1 and day8
Method of measurement
steps per min
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, each patient will be examined by a neurologist before starting the test and the degree of their movement disorder will be determined, then the degree of improvement of the patient's movement disorder will be examined separately or together after using visual, auditory and vibrational feedbacks .In order to evaluate these feedbacks, we have created a device in this field that provides all three required outputs.In this device, a rhythmic auditory pulse based on the number of pulses per minute is used for the auditory indicator.In the visual part, two linear lasers (step-by-step lighting) are used, which are connected to the patient's knee .It should be mentioned that the length of the step can be adjusted based on the patient's ability. Such activation of each laser is done by two sensors that are connected to the heel of the patients.In the following, the functional improvement of patients is measured with the help of sensory and vibrational feedback .Sensory-vibration feedbacks can be evaluated in a dependent or separate manner in such a way that a rhythmic vibrational pulse that can be dependent on the auditory marker is created or based on the patient's steps used by the sensors in the heels, to be activated.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurological clinic of Ghaem hospital
Full name of responsible person
Khashayar Atiaee
Street address
Mahhad, Ahmadabad Blvd, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Street address
in the end of Shahid fakouri Blvd, in front of Fakouri 94, knowledge and health city, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3843 6727
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?