To determine the effectiveness of high-amplitude intense exercises with the Silverman-voice therapy in improving bradykinesia in Parkinson disease
Design
A randomized, blinded, sham controlled clinical trial with a parallel group design of 30 patients, enrolled between April 2023 and November 2023, and followed for one month
Settings and conduct
Study setting: Physiotherapy Clinic
Study duration: The study will conducted over a period of 8 months.
Outcome measure: .Cognitive and motor TUG tests , Montreal Cognitive Assessment
Procedure: Patients clinically diagnosed as Idiopathic PD by a Neurologist will enroll in the study.patients will assign through purposive sampling method into control and experimental groups.Prior and after 4 weeks each and every subject underwent test using theCognitive and motor TUG tests , Montreal Cognitive Assessment.
The Kolmogorov-Smirnov test will be used to check the normality.
Repeated measures ANOVA with Bonferroni's post hoc test, independent and paired t-tests for inter- and intra-group comparisons will be used. If necessary and analysis of covariance (ANCOVA) is also used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diagnosed as Idiopathic Parkinson and stable medication 4 weeks prior to inclusion
Exclusion criteria: severe depression and any medical or musculoskeletal contraindications to exercise
Intervention groups
Control Group: The patients in the control group will receive conventional muscle strengthening and balance training.
Experimental Group: In the experimental group the patients will given the standard protocol of LSVT training and conventional muscle strengthening and balance training.
Main outcome variables
Cognitive and motor TUG tests , Montreal Cognitive Assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190812044516N2
Registration date:2023-03-07, 1401/12/16
Registration timing:prospective
Last update:2023-03-07, 1401/12/16
Update count:0
Registration date
2023-03-07, 1401/12/16
Registrant information
Name
Nahid Tahan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1723
Email address
na_tahan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of high-amplitude intense exercises with the Silverman-voice therapy on the bradykinesia of patients with Parkinson
Public title
Effects of high-amplitude intense exercises in patients with Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed as Idiopathic Parkinson
stable medication 4 weeks prior to inclusion
Being able to walk for 6 m with or without aids
Exclusion criteria:
Severe depression
Any medical or musculoskeletal contraindications to exercise
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
1
Each sample is a patient
Randomization (investigator's opinion)
Randomized
Randomization description
we use block randomization to allocate participants to the groups with an equal sample size over time.
The groups will labeled (E= experimental, C= control). Then a block size of four will chose.So, there were six possible ways to equally assign participants to a block (EECC, ECEC, ECCE, CEEC, CECE, CCEE). Blocks were randomly chosen to determine the assignment of all 32 individuals (16 participants in each group). Allocation concealment is performed using sealed, opaque envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study do not know which group they are in.
The assessment of patients before and after the intervention will be done by another physiotherapist who is not aware of the study procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid behehsti university of medical sciences
Street address
No.15, Yaman St, Arabi St, Next to Taleghani Hospital, Chamran High way,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.609
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
Motor TUG test
Timepoint
Before the intervention and one month after the start of the intervention
Method of measurement
Time duration of test in second
2
Description
Cognitive TUG test
Timepoint
Before the intervention and one month after the start of the intervention
Method of measurement
Time duration of test in second
3
Description
Montreal Cognitive Assessment
Timepoint
Before the intervention and one month after the start of the intervention
Method of measurement
The score of test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in the intervention group will perform general physical therapy exercises (including stretching and strengthening exercises) along with the Lee Silverman Standard Method exercise program, which includes high-amplitude, high-intensity exercises. The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions
Category
Rehabilitation
2
Description
Control group: The participants in the control group will perform general physical therapy exercises (including stretching and strengthening exercises).The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions