Objectives: The purpose of this study is to evaluate the effect of vestibular exercises on fatigue in patients with Parkinson's disease. Design: Participants are selected from men and women with Parkinson, aged 50 and older. 28 participants are randomly assigned into control and intervention groups by coded envelops. Setting and conduct: Evaluations are done two times before and after the intervention by a trained Occupational Therapist who is blind to type of groups. Participants: Subjects must be in level 1 to 4 of Parkinson. Intervention: After the baseline assessments, treatment sessions are given, 3 sessions per week, each session about 55-60 minutes for 24 sessions. Vestibular exercises are classified into five general categories, including the body standing without moving on the ground, the body in the form of a stench on the floor, the body standing on the trampoline, walking, and, finally, exercises related to the movements of the eye. Main outcome measures: Functional Independence Measure and Parkinson Fatigue Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709123551N6
Registration date:2017-09-28, 1396/07/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Parvin Raji
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
praji@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education and research,Tehran University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vestibular exercises on fatigue in patients with parkinson’s disease
Public title
The effect of vestibular exercises on fatigue in patients with parkinson’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The diagnosis of Parkinson's disease according to the neurologist; absence of severe visual and auditory disorders; lack of diabetes; osteoarthritis and osteoporosis, especially in the lower limbs; any other neurological disease including stroke; having a Parkinson level of 1 to 4 according to Hoehn and Yahr; all tests and evaluations are done in the phase of the drug (when the medication has most of its effects and symptoms associated with non-drug use have completely subsided), if consumed, it should be discontinued 24 hours before the videonistagmography test; The ability to walk with or without auxiliary equipment at least 100 meters in length; Having a cognitive level above 23 in the MMSE exam; Having fatigue with a mean score of 3.3 according to the Parkinson Fatigue Scale and lack of severe depression (score less than 29) based on the Beck depression inventory; Diagnosis of Central Vestibular Disorder by Audiologist by (VNG) Test Videonystagmography; Not having severe sleep disorder using the Pittsburgh Sleep Quality Index (PSQI-P) score less than 5, and lack of stress and anxiety (score less than 78) by The Depression Anxiety Stress Scales (DASS)
Exclusion criteria: Failure to co-operate with the patient during tests and exercises; Failure to return a patient to perform second-stage tests after interventions; Patients undergoing a change in their diet
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization by coded envelop
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3210
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Parkinson Fatigue
Timepoint
before and immediately after the end of the intervention
Method of measurement
Questionnaire (Parkinson Fatigue Scale)
Secondary outcomes
1
Description
Functional Independence
Timepoint
before and immediately after the end of the intervention
Method of measurement
Questionnaire (Functional Independence Measure)
Intervention groups
1
Description
Control group: muscle stretching+ fatigue management