The effect of extroceptive and proprioceptive sensory stimulation on Activities of Daily Living, motor function and spasticity of upper limb in stroke patients
Objectives: The aim of this study is to evaluate the the effect of extroceptive and proprioceptive sensory stimulation on ADL, motor function and spasticity of upper limb in stroke patients. Design: Participants are from chronic stroke patients 50 years of age who are referred to the rehabilitation clinic in Isfahan Red Crescent. 60 eligible participants, are randomly assigned into control and intervention groups by coded envelopes. Setting and conduct: Evaluations are done three times before and after the intervention, and three weeks after intervention by a trained Occupational Therapist who is blind to type of group.Participants: Participants must have experienced just one stroke and live in chronic period. Interventions: After the initial evaluation sessions, sessions for intervention group is occupational therapy in addition to traditional interventions, including 4 sessions per week for 6 weeks and each session 45 minutes. Each session of intervention includes: Extroceptive and proprioceptive sensory stimulation. The control group receives occupational therapy traditional interventions. The main outcome measures: Barthel-index assessment test to assess activities of daily living, Fugle-meyer test to evaluate hand motor function, and Modified Ashworth scale used to evaluate spasticity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610223551N4
Registration date:2016-11-12, 1395/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-12, 1395/08/22
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,Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of extroceptive and proprioceptive sensory stimulation on Activities of Daily Living, motor function and spasticity of upper limb in stroke patients
Public title
The effect of extroceptive and proprioceptive sensory stimulation on Activities of Daily Living, motor function and spasticity of upper limb in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Only have experienced one stroke; live in chronic phase (more than 6 months have passed since their stroke); able to detect monofilament number 4.31 in their fingers; according to the Brunnstrom assessment criteria are in step 4 or upper than; have the ability to understand commands that have a point. Exclusion criteria: During the study, patients who experienced recurrent stroke or have no appropriate cooperation with the therapist or are absent in their therapy sessions are excluded.
Age
From 50 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed using sealed envelopes.
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
2016-10-17, 1395/07/26
Ethics committee reference number
IR.TUMS.VCR.REC.1395.789
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G45
ICD-10 code description
G45
Primary outcomes
1
Description
Activities of daily living
Timepoint
before intervention, three weeks after intervention, after intervention
Method of measurement
Barthel Index
Secondary outcomes
1
Description
Spasticity
Timepoint
before intervention, three weeks after intervention, after intervention
Method of measurement
Modified Ashworth scale
2
Description
hand function
Timepoint
before intervention, three weeks after intervention, after intervention
Method of measurement
Fugle-meyer test
Intervention groups
1
Description
Exteroceptive sensory stimulation such as brushing, icing, stretch pressure and Proprioceptive stimulation such as weight bearing on upper limb joints, including 4 sessions per week for 6 weeks and each session 45 minutes.
Category
Rehabilitation
2
Description
Traditional occupational therapy interventions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation clinic in Isfahan Red Crescent
Full name of responsible person
Maryam Derakhshanfar
Street address
Rehabilitation clinic in Isfahan Red Crescent
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for education,Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Jalili
Street address
Vice chancellor for education,7th floor,Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran
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 education,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
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
lecturer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
praji@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)