The present study aimed to investigate the immediate effects of plantar vibrationon balance in patients after stroke. The patients were recruited from neurological rehabilitation clinics of Tehran and Iran University of Medical Sciences. The inclusion criteria were patients with spastic hemiplegia who were able to stand and walk independently. Patients were excluded if they were taking anti-spastisity drugs.The patients were referred to neurological physiotherapy clinic, school of rehabilitation, Tehran University of Medical Sciences for vibration therapy. There was one group of subjects with stroke which received 2 interventions with one week interval. Twenty patients underwent treatment with active vibration (frequency 100 Hz, 5 minutes, single session) 7 days after placebo vibration (5 minutes while the device was off, single session). The primary outcome measure, balance control based on mini-BESTest: and the secondary outcome measures, spasticity intensity based on MMAS and passive range of motion; were assessed before and after placebo vibration as well as active vibration, applied to the more affected foot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102230430N1
Registration date:2016-11-18, 1395/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Soofia Naghdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 5132
Email address
naghdi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical study to investigate the immediate effects of plantar vibration on balance in patients after stroke
Public title
Effects of plantar vibration therapy on balance after stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hemiplegia after stroke; Spasticity intensity of affected ankle plantar flexors based on Modified Modified Ashworth Scale(MMAS)>=1; independent standing and walking; Ability to follow instructions.
Exclusion criteria: Taking anti-spastisity drugs; unwillingness to continue the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Department of Physiotherapy, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.TUMS.REC.1394.2152
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I69.4
ICD-10 code description
Sequelae of stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Balance
Timepoint
Before and immediately after plantar vibration and placebo vibration
Method of measurement
Calculating mini BESTest Score
Secondary outcomes
1
Description
Spasticity
Timepoint
Before and immediately after plantar vibration and placebo vibration.
Method of measurement
Based on Modified Modified Ashworth Scale(MMAS) scores
2
Description
Passive Range of Motion
Timepoint
Before and immediately after plantar vibration and placebo vibration.
Method of measurement
Goniometry
Intervention groups
1
Description
Intervention 1: plantar vibration. Vibration stimuli with a frequency of 100 Hz was applied for 5 minutes to the sole of more affected foot for one session.
Category
Rehabilitation
2
Description
Intervention 2: Placebo vibration. The affected foot was placed on the vibrator plate for 5 minutes while the device was off, for one session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurological physiotherapy clinic, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Azam Karimi Ahmadabadi
Street address
Neurological physiotherapy clinic, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Soofia Naghdi
Street address
Department of Physiotherapy, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation,Tehran University of Medical Sciences
Full name of responsible person
Dr. Soofia Naghdi
Position
Associate Professor, Physiotherapy Department of School of Rehabilitation
Other areas of specialty/work
Street address
Department of Physiotherapy, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
naghdi@tums.ac.ir; nakhostin@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation,Tehran University of Medical Sciences
Full name of responsible person
Dr. Soofia Naghdi
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Department of Physiotherapy, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
naghdi@tums.ac.ir; nakhostin@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation,Tehran University of Medical Sciences
Full name of responsible person
Dr. Soofia Naghdi
Position
Associate Professor, Physiotherapy Department of School of Rehabilitation
Other areas of specialty/work
Street address
Department of Physiotherapy, School of Rehabilitation, Pitch-e-Shemiran, Enghelab Avenue.
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)