Evaluating The effectiveness of bilateral versus unilateral robotic glove-assisted training on hand motor function and functional independence in stroke patients with unilateral involvement
To compare the effects of bilateral and unilateral robotic-glove-assisted hand exercises on hand motor function and functional independence in
Design
This study is a randomized parallel-group clinical trial in which 44 eligible patients will be randomly allocated using block randomization into two intervention groups: bilateral training using a robotic glove and unilateral training using a robotic glove. The sample size was calculated based on 80% power, a 0.05 significance level, and a moderate effect size.
Settings and conduct
This randomized clinical trial will be conducted on patients with stroke. Eligible participants will be enrolled after obtaining written informed consent and will be randomly allocated into two intervention groups. Rehabilitation interventions will be performed at the Comprehensive Rehabilitation Clinic of Mashhad University of Medical Sciences. Outcome assessments will be performed by an independent assessor blinded to group allocation, and statistical analysis will be conducted by a person blinded to the group assignments
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients with unilateral ischemic stroke aged 20–75 years, at least three months post-stroke, with the ability to understand and follow instructions and without severe spasticity. Exclusion criteria included other neurological disorders, upper limb fractures, concurrent participation in other rehabilitation or drug studies, and botulinum toxin injection within the past three months
Intervention groups
Intervention Group 1: bilateral training using a robotic glove
Intervention Group 2: unilateral training using a robotic glove
Main outcome variables
The primary outcome of this study is upper limb motor function, which will be assessed using the Upper Extremity section of the Fugl-Meyer Assessment (FMA-UE) before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221019056245N4
Registration date:2026-08-05, 1405/05/14
Registration timing:prospective
Last update:2026-08-05, 1405/05/14
Update count:0
Registration date
2026-08-05, 1405/05/14
Registrant information
Name
Khodabakhsh Javanshir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 6419
Email address
k.javanshir@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-22, 1405/05/31
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating The effectiveness of bilateral versus unilateral robotic glove-assisted training on hand motor function and functional independence in stroke patients with unilateral involvement
Public title
Comparing one-hand and two-hand robotic glove exercises to improve hand movement in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ischemic stroke
At least three months have passed since the onset of stroke
Age between 20 and 75 years
The patient must be able to understand and follow the therapists instructions as assessed by the Minimal-Mental State Examination
No severe spasticity(Modified Ashworth Scale)
Exclusion criteria:
Patients with a history of other neurological disorders, such as peripheral polyneuropathy, will be excluded from the study.
Patients with a history of fracture of the upper limb or hand will be excluded from the study.
Patients who are simultaneously participating in other pharmacological or rehabilitation studies will be excluded from the study.
Patients who have received botulinum toxin injections within the past three months will be excluded from the study.
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly allocated to either the bilateral robotic glove training group or the unilateral robotic glove training group using block randomization after obtaining informed consent. The unit of randomization will be the individual participant. A computer-generated random sequence will be used for randomization. Allocation concealment will be ensured using sealed, opaque, sequentially numbered envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, complete blinding of participants and therapists is not feasible. Participants will not be aware of their assigned group prior to the initiation of the intervention; however, they will become aware of the type of training after the intervention begins. Outcome assessors will be blinded to group allocation. In addition, statistical analysis will be performed by an analyst who is blinded to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
This study does not have any unique design features beyond those already described in the previous sections
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganj afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2025-12-08, 1404/09/17
Ethics committee reference number
IR.MUBABOL.REC.1404.187
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
n this study, upper limb motor function is considered the primary outcome and will be assessed using the Upper Extremity section of the Fugl-Meyer Assessment (FMA-UE). Assessments will be performed before and after the intervention period.
Timepoint
Primary outcome will be assessed at two time points: before the intervention and immediately after completion of the intervention period.
Method of measurement
Upper limb motor function will be measured using the Upper Extremity section of the Fugl-Meyer Assessment (FMA-UE). All assessments will be performed by a trained and independent assessor who is blinded to group allocation, before and after the intervention.
Secondary outcomes
1
Description
The secondary outcome of this study is functional independence, which will be assessed using the Functional Independence Measure (FIM). This measure reflects the level of independence in activities of daily living and will be evaluated before and after the intervention period.
Timepoint
The secondary outcome will be assessed at two time points: before the intervention and immediately after completion of the intervention period.
Method of measurement
Functional independence as the secondary outcome will be measured using the Functional Independence Measure (FIM). Assessments will be conducted by a trained and independent assessor blinded to group allocation, before and after the intervention.
Intervention groups
1
Description
Intervention group:Group 1 (Bilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions over one month (three sessions per week). Each session consists of two phases:1.Ten minutes of conventional physiotherapy including stretching, weight-bearing, and range of motion exercises 2. Robotic glove training consisting of two types of exercises:1.Finger opening and closing 2.Finger opposition movements. Each exercise will be repeated 100 times. The robotic glove exercises are performed with both hands simultaneously.Group 2 (Unilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions similar to Group 1. The session sequence and duration are the same (ten minutes of physiotherapy followed by robotic glove training). The difference is that robotic glove exercises are performed only with the affected hand, including finger opening and closing and finger opposition, each repeated 100 times.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Rehabilitation Center
Full name of responsible person
Hossein Negahban
Street address
Comprehensive Rehabilitation Center, Parastar 2 Alley, Ahmadabad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz St, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences,Ganjafrooz St., Babol
City
Babol
Province
Mazandaran
Postal code
471767745
Phone
+98 11 3219 9592
Email
Khodabakhshjavanshir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganjafrooz St, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
Khodabakhshjavanshir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganjafrooz St, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
Khodabakhshjavanshir@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available