Investigating the effectiveness of biofeedback exercise on reducing hand tremors in Parkinson's patients
Design
A clinical trial with two parallel groups (intervention group and sham) with triple blind strains on 18 patients
Settings and conduct
Parkinson's patients are treated for 10 sessions at the neurologist's office. According to their nature, the intended messages are checked before the session, during the test and after the session.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:
1) Diagnosis of Parkinson's disease based on UPDRS criteria
2) Presence of resting tremor in at least one hand
3) Absence of mood disorders (depression or anxiety disorder) Informed consent
4) Consent to participate in the study.
Conditions for not entering the study:
1) Severe disability that prevents the patient from cooperating in the trial
2) Symptoms of neuropathy and other neurological disorders affecting feedback
Intervention groups
The intervention group performs 10 sessions of biofeedback exercises to control hand tremors at rest.
The Sham group tries to control their hand tremors in 10 sessions by using the device in off mode
Main outcome variables
In this study, tremor measurement based on UPDRS and accelerometer data are measured as the main outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230226057541N1
Registration date:2023-10-17, 1402/07/25
Registration timing:prospective
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Sajedeh Movahedian Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3729 8358
Email address
s.movahedian.91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of biofeedback exercise on reducing hand tremors in Parkinson's patients
Public title
Investigating the effectiveness of biofeedback on reducing hand tremors in Parkinson's patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Parkinson's disease based on UPDRS criteria
rest tremor in at least one hand
Absence of mood disorders (depression or anxiety disorder)
Informed consent
Exclusion criteria:
Severe disability that prevents the patient from cooperating in the trial
Symptoms of neuropathy and other neurological disorders affecting feedback
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster randomization using Excel software; to assign the participants to each of the intervention and sham groups, we use the rand and rank functions in Excel software. By using these functions, half of the participating population is selected for the intervention group and the other half is assigned to the sham group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The clinical trial will be done in a triple-blind way.
1- The person who divides the patient into two groups is one of those interventions that does not identify the patients. The list of patients is divided into two intervention and sham groups by random selection in Excel.
2- It is clear whether they are in the intervention or sham group.
3- All the recorded data are analyzed, and it is determined whether it belongs to the intervention or sham group. Patients are divided into two groups by random selection of Excel software, and each person is assigned a code, and data analysis is performed for each code, and the analyst is completely blinded to the patients.
Placebo
Not used
Assignment
Parallel
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
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.235
Health conditions studied
1
Description of health condition studied
Parkinson
ICD-10 code
G520
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Postural tremor of hands
Timepoint
Before starting interventions, after completing interventions, follow-up session
Method of measurement
Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS)
2
Description
Kinetic tremor of hands
Timepoint
Before starting interventions, after completing interventions, follow-up session
Method of measurement
Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS)
3
Description
Rest tremor amplitude
Timepoint
Before starting interventions, after completing interventions, follow-up session
Method of measurement
Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS)
4
Description
Constancy of rest tremor
Timepoint
Before starting interventions, after completing interventions, follow-up session
Method of measurement
Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS)
5
Description
Characteristics of hand tremor accelerometer
Timepoint
During training with the device
Method of measurement
Using an accelerometer
Secondary outcomes
1
Description
Quality of life scale in Parkinson's disease PDQ-39
Timepoint
Before starting interventions, after completing interventions, follow-up session
Method of measurement
Quality of life in Parkinson's disease PDQ-39 Questionnaire
Intervention groups
1
Description
Intervention group: 10 sessions of biofeedback training to control hand tremors
Category
Rehabilitation
2
Description
Control group: trying to control the hand tremor, by holding the device in turned-off mode in 10 sessions