A comparison between the effects of Task-Oriented Training combined with Bobath programme and Task-Oriented Training alone on the function of upper extremity in post-stroke hemiparesis patients
Stroke is the third cause of death worldwide. Upper extremity function is one of the important factors that are affected by stroke and it can cause disability. Some rehabilitation approaches specifically developed for hemiparesis after stroke is Task Oriented Training and Bobath program. Researchers have shown the best approach to improve upper limb function is still not evident and there is no article showing that one of the approaches gives better outcomes than the others.
Methods: Sixteen patients with hemiparesis due to stroke were allocated randomly to either an intervention or control group. The intervention group will receive a combination of Task-Oriented Training with Bobath program for 60 minutes 3 days in a week for 6 weeks, and the control group will receive a Task-Oriented Training alone for 60 minutes. Fugl Meyer Test, Wolf Motor Function Test, Barthel ADL Index, Hand Strength Test, Modified Functional Reach Test, and the Modified Ashworth Scale will be done before treatment, in the 6th session, and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051316680N4
Registration date:2017-07-16, 1396/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-16, 1396/04/25
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2018-03-14, 1396/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effects of Task-Oriented Training combined with Bobath programme and Task-Oriented Training alone on the function of upper extremity in post-stroke hemiparesis patients
Public title
A comparison between the effects of Task-Oriented Training combined with Bobath programme and Task-Oriented Training alone on the function of upper extremity in post-stroke hemiparesis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: first unilateral hemiparesis following stroke ranging between 2-12 months (sub-acute and chronic stage); MMSE more than 20; Motor recovery of hand Brunnstrom stages ≥ 3; score of spasticity of the elbow flexors ≤ 3 based on the Modified Ashworth Scale (MAS); they must have 45-70 years of age; score of Depression based on the Geriatric Depression Scale (GDS) ≤ 8; and they do not receive any upper-limb rehabilitation programs during the participation in this study.
Exclusion criteria: they have previous injury, disease, or contracture of the upper extremity; no sitting balance; any co-morbid neurological disease or condition such as multiple sclerosis, Parkinson disease, spinal cord injury, traumatic brain lesions, brain tumor, epilepsy, or dementia; and they have Hemineglect phenomena.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-08-24, 1395/06/03
Ethics committee reference number
IR.IUMS.REC.1395.9323699003
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G81.1
ICD-10 code description
Cerebral palsy and other paralytic syndromes
Primary outcomes
1
Description
Upper limb function
Timepoint
Exactly before the treatment, in the six treatment session,and exactly after the treatment
Method of measurement
By Wolf Motor Function Test
2
Description
Strength of the hand
Timepoint
Exactly before the treatment, in the six treatment session,and exactly after the treatment
Method of measurement
by using Hand Strength Test
3
Description
Motor function of upper extremity
Timepoint
Exactly before the treatment, in the six treatment session,and exactly after the treatment
Method of measurement
By using Fugl Meyer Test
4
Description
Sitting balance
Timepoint
Exactly before the treatment, in the six treatment session,and exactly after the treatment
Method of measurement
By using Modified Functional Reach Test
Secondary outcomes
1
Description
Activities of Daily Living
Timepoint
Exactly before the treatment, in the sixth treatment session,and exactly after the treatment
Method of measurement
By using Barthel ADL Index
2
Description
Muscle tone
Timepoint
Exactly before the treatment, in the sixth treatment session,and exactly after the treatment
Method of measurement
By using Modified Ashworth Scale
Intervention groups
1
Description
The control group will receive Task-Oriented Training program alone for 60 min.
Category
Rehabilitation
2
Description
The intervention group will receive combination of Task-Oriented Training with Bobath programfor 60 min: 30 min Bobath programme and 30 min Task-Oriented Training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
College clinic of physiotherapy at School of Rehabilitation Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Street address
School of Rehabilitation Sciences, Nezam Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Cancellor for Research of Iran University of Medical Sciences
Full name of responsible person
Sima Khalina
Street address
School of Rehabilitation Sciences, Nezam Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Cancellor for Research of Iran 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
Technology and Research Deputy of Iran University of Medical Sciences
Full name of responsible person
Seyyed Ali Javad Mousavi
Position
Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
research@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitat Sciences, Iran University of Medical Sciences.
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Postal code
Phone
+98 212222712
Fax
Email
Noorizadeh.sh@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitat Sciences, Iran University of Medical Sciences.
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
Noorizadeh.sh@iums.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)