1. To compare the effect of robot glove and rubber balls exercise on the hand function.
2. To find the relationship between the demographical data and the function of hand after rubber ball exercise and soft robot glove rehabilitation.
Design
A randomized control trial
Settings and conduct
A physical rehabilitation center was opened in Iraq (Mosul).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The participants were at least 2 weeks after the onset of stroke.
2. Muscle spasticity during extension at the finger joints and the wrist joint was below 3, as measured by the Modified Ashworth Scale (MAS).
3. The patient’s age is ≥ 20 years old.
4. No visual deficit and able to understand and follow simple instructions.
Exclusion criteria:
1. Patients who have cognitive deficits, visual impairment, and other medical disorders (tremors, diabetes).
2. Contractures of the affected upper limb interfering with positioning in the device.
Intervention groups
Samples were divided into three groups: two experiments and one control. The data were collected by standardized measures, and all study groups were assessed on a on a pre-rehabilitation program to assess the level of the patient’s hand function using study tools. 20 rehabilitation sessions were conducted per week, two to three sessions per week, every session lasted 10 minutes, eight for exercise and two for rest, as all patients were evaluated every week to determine the improvement of hand function.
Main outcome variables
Improved hands function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240623062222N1
Registration date:2024-07-15, 1403/04/25
Registration timing:prospective
Last update:2024-07-15, 1403/04/25
Update count:0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Tameem Thamir
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 770 165 7085
Email address
tameem.mayuf2202p@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-01, 1403/05/11
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the Soft Robotic Glove and Rubber Ball to restoring Hand Function for Patients with Stroke
Public title
Comparison between the Soft Robotic Glove and Rubber Ball to restoring Hand Function for Patients with Stroke
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1. The participants were at least 2 weeks after the onset of stroke.
2. Muscle spasticity during extension at the finger joints and the wrist joint was below 3, as measured by the Modified Ashworth Scale (MAS).
3. The patient’s age is ≥ 20 years old.
4. No visual deficit and able to understand and follow simple instructions.
Exclusion criteria:
1. Patients who have cognitive deficits, visual impairment, and other medical disorders (tremors, diabetes).
2. Contractures of the affected upper limb interfering with positioning in the device.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
The graphPad program (GraphPad Software, San Diego, California, USA) simply selected samples at random and performed online. Samples were then divided into three groups: two experiments and one control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ministry of Planning - Authority of statistics / Iraq.
Street address
Mosul, Al-Wahda street
City
Mosul
Postal code
41001
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
1/3/1/18/3799
Health conditions studied
1
Description of health condition studied
patients with stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
The patients’ motor performance will improve after applying rehabilitation (picking up stuff, eating, and writing).
Timepoint
before intervention and 2, 4, 6, 8, 10, 12, and 14 weeks after intervention
Intervention group: After randomization, the patients will be divided into three groups. then obtaining the patient's consent and explaining the device's operation to him. Intervention Group 1: A soft robotic glove will be used to rehabilitate the patients’ hands for a period of 14 weeks, with two sessions each week. Intervention Group 2: will use a rubber ball to rehabilitate the patients’ hands for a period of 14 weeks, with two sessions each week. All groups will be evaluated every week to show hand function improvement.
Category
Rehabilitation
2
Description
Control group: The control group will use the rehabilitation program followed in the center, where the data is to be collected.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
A physical rehabilitation center was opened in Iraq / Mosul
Full name of responsible person
Saad Allah Abdul Aziz Khadr
Street address
Mosul, Al-Wahda street
City
Mosul
Postal code
41001
Phone
+964 774 086 7453
Email
tameem.thamer@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Baghdad
Full name of responsible person
Mohammed Baqer Abas Al-Jubouri
Street address
Baghdad
City
Baghdad
Postal code
480001
Phone
+964 770 165 7085
Email
tameem.thamer@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personally
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Mohammed Baqer Abas Al-Jubouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad
City
Baghdad
Province
Baghdad
Postal code
480001
Phone
+964 773 768 4460
Email
maaljubouri@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Tameem Thamir
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Baghdad
City
Baghdad
Province
Baghdad
Postal code
480001
Phone
+964 770 165 7085
Email
tameem.thamer@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Tameem Thamir
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Baghdad
City
Baghdad
Province
Baghdad
Postal code
480001
Phone
+964 770 165 7085
Email
tameem.thamer@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be published after being statistically analyzed and compared with previous research.
When the data will become available and for how long
starting in September 2025
To whom data/document is available
academic institutions and others
Under which criteria data/document could be used
for academic use or research use
From where data/document is obtainable
Tameem Thamir
tameem.thamer@gmail.com
What processes are involved for a request to access data/document